FDA Clarifies Stance on Clinical Trial Reimbursements for Patient Travel, Lodging

The FDA has updated its guidance to institutional review boards and clinical investigators clearly allowing reimbursements to patients in clinical trials for lodging and travel.

While paying subjects for participation in clinical research may raise difficult questions that should be addressed by an IRB, reimbursements for travel expenses to and from trial sites are not considered to raise issues regarding undue influence, according to the agency’s Office of Good Clinical Practice.

FDA Commissioner Scott Gottlieb highlighted the new passage in the guidance on travel reimbursement, saying the agency hopes “this clarity encourages recruitment in clinical trials.”

The change in the FDA’s guidance reflects how the industry has begun to shift how it conducts clinical trials, said Lindsay McNair, chief medical officer of WIRB-Copernicus Group.

“It used to be that people who were participating in clinical trials were very near a clinical site,” McNair said. “They would have some parking expenses, or they might have taxi fare.”

“But especially as we move into rare disease areas — where people may be coming from other parts of the country to special treatment centers to participate in research — the amount of reimbursement for travel expenses becomes plane tickets for someone and their spouse and two nights in a hotel.”

For instance, a study on hypertension may have many potential participants available locally; studies in Duchenne muscular dystrophy patients carrying a particular genetic mutation, however, would require a larger recruiting footprint, she said, meaning a higher likelihood of paying travel expenses.

In contrast to reimbursement, the guidance states that ethics reviews should continue to examine how much compensation participants receive, including for reasons such as time, inconvenience or discomfort.

“IRBs should be sensitive to whether other aspects of proposed payment for participation could present an undue influence, thus interfering with the potential subjects’ ability to give voluntary informed consent,” the guidance said, adding that payments should be just and fair.

IRBs should receive the amounts and schedule of all payments, including end-of-study bonuses, during the initial review to ensure that they are not coercive according to federal regulations, including 21 CFR 50.20, the agency said. All information concerning payment should be spelled out in the informed consent document.

Credits for payment should accrue as the study continues, and not be contingent on study completion; however, a small proportionate payment to incentivize completion is acceptable, as long as it is not coercive, according to the guidance.

The question of what type of reimbursement crosses the line into undue influence or coercion has typically caused more stress for sponsors and researchers than IRBs, McNair said.

By comparison, IRBs — as well as Phase I research units with experience recruiting healthy volunteers to studies — all have a pretty good idea of what kind of compensation amounts will be considered appropriate.

“It’s something they’ve been very used to considering,” McNair said. “We very rarely see anything come through where we need to push back on a payment plan,” especially in a study that an IRB has already decided has a reasonable risk.

Many research organizations and sponsors keep payment schedules — detailing how much they compensate for blood draws, nights spent in the clinic and other study procedures, for example — creating a guide to what they know IRBs have considered appropriate in the past.

But sponsors in all phases of clinical trials can be very concerned with the optics of offering patients money to participate in research, and often seek IRB input.

The FDA guidance is a welcome update, McNair said. “It’s nice to have them explicitly clarify the difference between compensation and reimbursement.”

“The previous guidance didn’t really separate those two things out, and I think it did cause some confusion to people in trying to plan what they wanted to do in a study,” she said, adding that it probably won’t change how IRBs weigh the issue.

When examining a submission, the boards typically break those two considerations apart to judge them individually, even if the two are not explicitly described by the sponsor in the protocol or consent form.

“We do think it’s generally appropriate for people not to have to pay out-of-pocket expenses to participate in research,” said McNair. “We don’t want the subject to incur those expenses, and we also look at it from the concept of justice and equitable subject selection.”

If only the people who can participate in research are those who can afford the travel expenses upfront, that could greatly limit who can be recruited into a study, she said. The larger issue of research subject compensation has had a tremendous amount of discussion in the IRB space, and how study protocols should balance the issue of undue influence and respect for patients.

The full FDA guidance is available here: https://www.fda.gov/RegulatoryInformation/Guidances/ucm126429.htm .

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Chart the course to success.

When you are deciding whether to join a clinical trial, you should consider logistics.

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  • Clinical trials vary in length and time commitment. The research team can work with your regular CF care team to accommodate your schedule and make participating as easy as possible.
  • Clinical trials happen at CF care centers all over the country. You can volunteer for any trial you qualify for, regardless of location.
  • You will not be charged a fee to participate in a clinical trial, but you may incur expenses ⁠— such as meals, mileage, and parking ⁠— as a result of participating. Most studies offer reimbursement for these kinds of study-related expenses.

Accommodating Your Schedule

Some studies only require a single visit, while others require many visits over a longer period of time. Study visits can also vary in length ⁠— one study might only require a quick blood draw, while another may require several hours of testing. Ask the research team about the time commitment for the trial so you know how many visits you will need to make and how long they will last.

If the trial is taking place at your care center, the research team can coordinate with your CF care team so that you can do the study visit and your regular quarterly visit on the same day. Appointments can be moved to the beginning or end of the day to accommodate your work schedule.

If you believe there are other obstacles to participating, your research team might be able to engage in some creative problem-solving with you. For example, some parents have had problems with schools allowing time off for children with CF to participate in clinical trials. If that is the case, your care center doctor can send a letter to the school stating why the children need to participate.

Traveling to a Different Care Center

Some trials may take place at your usual care center, but other trials are happening at different care centers all over the country. You can ask to participate in any clinical trial you qualify for, regardless of location.

If you choose to participate in a trial that is farther away, you'll need to think about travel to the study site:

  • Will you drive, fly, or take other transportation to get there?
  • Will you need to stay overnight in a hotel?
  • Will you need to take time off from work?
  • Will you need child care during the study visit?

In some cases, the research team may be able to arrange for some of the study visits to take place closer to you. For Brandon Erhart, an adult who has CF, the research team was able to arrange for him to get the study's routine blood draws at a hospital close to his college campus. This saved him from having to travel two hours to get them done at the study site.

“I've just had nothing but collaboration on all ends, which has been really positive.” — Brandon Erhart, who participated in three CF clinical trials

Compensation and Reimbursement

You will not be charged a fee to participate in a clinical trial, but you may incur expenses as a result of participating.

Most studies offer reimbursement for these kinds of study-related expenses:

Some expenses, such as child care, may not be covered. Before enrolling in a trial, ask the research team if these costs will be reimbursed.

If the trial is more than 200 miles away, the study sponsor will usually cover the cost of flying. For minors, the study sponsor will pay for the participant and one parent or guardian. Consideration may be given to offsetting the travel costs of a travel companion for adults.

If you are unable to cover study-related expenses upfront, ask the research team if they can make arrangements for you. They may be able to cover certain costs ⁠— such as providing a prepaid gas card or a ride service to and from study visits — so that you don’t need to wait to be reimbursed.

How Does Compensation Work?

In addition to reimbursing your expenses, some clinical trials may compensate you for participating. This is a decision made by the trial sponsor, who is paying for the study. You will receive information about compensation during the informed consent process before the study begins.

Compensation varies and is given to pay for your time. It can help offset the costs of participating that are not reimbursed, such as time taken off from work. For trials within the Therapeutics Development Network , the most recent guidelines for compensation for a participant (or a parent who needs to take time off of work to bring a child in for a study visit) suggest a maximum of $30 an hour, up to a maximum of $300 for a single visit. These amounts may be adjusted in areas where the cost of living is higher than the rest of the country.

The Cystic Fibrosis Foundation spearheaded an effort to ensure that those with rare diseases such as CF can receive compensation for participating in clinical trials without losing critical benefits. The Ensuring Access to Clinical Trials Act allows participants in clinical trials for rare disease therapies to receive up to $2,000 a year without that compensation affecting their eligibility for Supplemental Security Income or Medicaid benefits.

Compensation and Taxes

The IRS requires research institutions to report compensation to clinical trial participants if the amount is $600 or more a year. Your study site will send you IRS Form 1099 as a record of this payment for you to include with your tax return. Reimbursement of expenses is not considered compensation.

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  • Payment and Reimbursement to Research Subjects


Payment and Reimbursement to Research Subjects Guidance for Institutional Review Boards and Clinical Investigators January 2018

This guidance represents the current thinking of the Food and Drug Administration (FDA or Agency) on this topic.  It does not establish any rights for any person and is not binding on FDA or the public.  You can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations.  To discuss an alternative approach, contact the FDA staff responsible for this guidance as listed below.

The Institutional Review Board (IRB) should determine that the risks to subjects are reasonable in relation to anticipated benefits [21 CFR 56.111(a)(2)] and that the consent document contains an adequate description of the study procedures [21 CFR 50.25(a)(1)] as well as the risks [21 CFR 50.25(a)(2)] and benefits [21 CFR 50.25(a)(3)].

Paying research subjects in exchange for their participation is a common and, in general, acceptable practice.  Payment to research subjects for participation in studies is not considered a benefit that would be part of the weighing of benefits or risks; it is a recruitment incentive. FDA recognizes that payment for participation may raise difficult questions that should be addressed by the IRB.  For example, how much money should research subjects receive, and for what should subjects receive payment, such as their time, inconvenience, discomfort, or some other consideration.  In contrast to payment for participation, FDA does not consider reimbursement for travel expenses to and from the clinical trial site and associated costs such as airfare, parking, and lodging to raise issues regarding undue influence.  Other than reimbursement for reasonable travel and lodging expenses, IRBs should be sensitive to whether other aspects of proposed payment for participation could present an undue influence, thus interfering with the potential subjects’ ability to give voluntary informed consent.  Payment for participation in research should be just and fair. The amount and schedule of all payments should be presented to the IRB at the time of initial review. The IRB should review both the amount of payment and the proposed method and timing of disbursement to assure that neither are coercive or present undue influence [21 CFR 50.20].

Any credit for payment should accrue as the study progresses and not be contingent upon the subject completing the entire study. Unless it creates undue inconvenience or a coercive practice, payment to subjects who withdraw from the study may be made at the time they would have completed the study (or completed a phase of the study) had they not withdrawn. For example, in a study lasting only a few days, an IRB may find it permissible to allow a single payment date at the end of the study, even to subjects who had withdrawn before that date.

While the entire payment should not be contingent upon completion of the entire study, payment of a small proportion as an incentive for completion of the study is acceptable to FDA, providing that such incentive is not coercive. The IRB should determine that the amount paid as a bonus for completion is reasonable and not so large as to unduly induce subjects to stay in the study when they would otherwise have withdrawn. All information concerning payment, including the amount and schedule of payment(s), should be set forth in the informed consent document.

Office of Good Clinical Practice, Updated Jan. 25, 2018

Also see these FDA Information Sheets: "A Guide to Informed Consent" "Recruiting Study Subjects."

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Submit comments on this guidance document electronically via docket ID: FDA-2013-S-0610 - Specific Electronic Submissions Intended For FDA's Dockets Management Staff (i.e., Citizen Petitions, Draft Proposed Guidance Documents, Variances, and other administrative record submissions)

If unable to submit comments online, please mail written comments to:

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All comments should be identified with the title of the guidance.

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Clinical Trial and Travel Tribulations

Improving Access and Outcomes for Patients and Caregivers, Sites and Sponsors

In this paper, we dive into the logistical and financial challenges which increasingly impact all clinical trial stakeholders - from patients and sites, to sponsors and CROs.

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With proper planning and the right partner on board, travel arrangements and reimbursement programs can make the trial and patient experience more comfortable and successful for everyone.

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It would be an understatement to say that at no time in our history has the importance of clinical trials been so severely tested.

As COVID-19 vaccines are being developed in all parts of the world, we are now seeing an unprecedented system taking place where clinical trials that use to take years are now taking mere months to come to fruition.

Still, such unique development does not come without barriers in place. The pandemic has, in essence, shrunk our world, as countries close borders to the point of virtually isolating themselves from their geographic neighbors. Thus travel, which had become collateral damage to the pandemic, has become restrictive and forced clinical trials to adapt to a more compact world. Yes, visits can still happen safely but combining central site visits and local doctor visits could be the way to go. And who better to coordinate this new normal in clinical trial travel than a Travel Management Company (TMC)?

Specialized clinical trials’ travel services were developed more than a decade ago. The demand for these services grew as it became apparent that CROs were struggling to manage travel and expenses for their trial subjects. Confidentiality rules and regulations stipulated by regulatory bodies such as the FDA and EMA meant that the sponsor could not access specific information on subjects, and this in turn meant that it was extremely difficult to arrange the reimbursement of clinical travel costs and other expenses with the participants.

The solution was that the TMC would intervene between the investigating site and the sponsor. And as they are classed as independent organizations, the subjects were given the choice as to whether or not to use the service. Those who did were able to contact the service provider directly. As the service is optional and is operated in conjunction with pre-approved travel and expense guidelines, Institutional Review Boards (IRBs) are satisfied that the subjects are not being enticed to use the service.

By assigning codes for the subject and the study in place of personal information, travel is organized on the subject’s behalf. All the bills are sent directly to the TMC, where they are desensitized and then charged back to the sponsor. The sponsor’s corporate credit cards cannot be used for any element of the travel reservation process, as the details of the subjects would appear on the credit card bills.

To guarantee that there is no leaking of personal information, the corporate accounts of the TMC are used for all billing, reimbursement and reservation processes. Using a three-stage manual check process, information is desensitized and then reported back to the sponsor, who is only able to see the subject’s IDs, dates of booking, types of travel and cost (they are not able to access specific information on subjects). This level of reporting allows the sponsor to maintain control of costs and to ensure the subject IDs correspond with dates of clinic visits.

But in today’s shifting world, some things have to be observed through the prism of a pandemic, where the well-being of the test subject is paramount. This means budgets have been changed to allow for apartments over hotels, car rentals instead of Uber, etc. Most patient guidelines are now put in place to minimize the subject’s proximity to the general public in order to mitigate exposure. We’re still seeing key visits at central sites as before, but now there are more sites local to the patients and the patient’s MD, not only cutting down on the risk of COVID-19 by keeping all patient travel local, but to help the study keep to its timetable. We’re also looking at options for hospitals where they can discharge patients early after procedures into a “clean” environment chosen so that the hospitals can get through their backlog. For this, we work with trusted apartment vendors and we instruct the cleaners and lay out the standards required for post hospital stay patients.

One of the first things we do when engaging with a pharma (Trial Sponsor) is ask for a copy of the study protocol. The protocol lays out the “road map” for the study as well as the site visits (days at clinic). Each one of those days on site can be three days away from home. For instance, an entire day visit in Houston for someone from Atlanta means travelling the day before, having the day on site and then likely staying the night of the visit. Once we read the protocol we ask these questions and lay out a patient expectation and associated budget. This helps the pharma understand what a one-day visit will cost but also, once we’ve created the patient guidelines, these can be used as part of the enrolment process. Something as simple as taking away the stress of the unknown and spelling out the exact participant expectations can bring us one step closer to the overly claimed, but often not achieved, goal of “patient centric clinical trials.”

Make no mistake, when it comes to clinical trials, travel was always a daunting task. But now we have to step up our game. For example, during one trial, subjects from Paraguay were happy to travel by ferry from Montevideo to Buenos Aires and back again in one day, in order to receive infusions. But as more and more countries shutter their borders, trials must adapt to working within their own geographic space. And in some countries, such as the USA, individual states are putting in place protocols for travelling from one state to another.

The good news is that by combining a study timetable and details of site locations, we now allow for effective travel and expense budgeting for clinical trials. Advance planning of medical trial logistics is key to keeping control of costs. It is wrong to assume that because we are unable to travel between countries that we no longer have to be budget-conscious. A common error when planning trial logistics can be underestimating the size of a country. Certain studies, including rare disease studies, may only have three or four sites that are suitable for testing in any given region. It is easy to assume that domestic travel is relatively straight forward and cost effective, this is often not the case. However, very often precise relocation can be a more cost-effective option than regular cross border travel. Limiting travel can also be less of an ordeal to the subject than a gruelling travel schedule that can last a couple of years. A travel management service with clinical expertise will have the ability to help with relocation services.

Being proactive is key when organizing travel services for clinical trials. Often study protocols and timetables focus only on the science and not on the travel times involved. One day on site can mean three days travel time for subjects, depending on the length of appointment and availability of transport. Through viewership of the protocol the TMC can humanize the study schedule, which means subjects know exactly the time commitment required before joining the study. Communication of the actual time expectations, not just the number of visits, at the enrolment stage results in a higher retention rate.

A travel management service is seen by the subject as a neutral party and this generally means that subjects will communicate both willingly and freely, which allows the TMC to help them and, in turn, maintain their confidence. Each requirement is contemplated individually and every aspect and detail of the operation, from home to clinic, is arranged for them. For example, air travel can be unnerving for subjects who require special care and assistance, such as those in wheelchairs and those who require access to oxygen. By liaising with airlines and using established partnerships, a TMC can ensure travel is as seamless as possible for the subjects. If a subject requires specialized medical care while travelling, arrangements can be made for road or air ambulances, ensuring optimum comfort and medical care for the journey.

The benefits of working with a TMC on these crucial aspects of clinical trials are numerous. Ultimately the sponsors retain control of costs and receive meaningful reporting. The CRO has a greatly reduced amount of administration, removing the hassle of organizing subjects’ travel and reimbursing expenses, allowing them to concentrate on their primary role.

Additionally, improved budget control and cost savings can help the sponsor reduce expenditure by providing a study schedule that ensures travel can be effectively planned in advance. In turn, this ensures smooth travel arrangements, which leads to improved continuity in studies, happier and motivated subjects and a reduced risk of missed appointment visits or subjects leaving a study early, which are both an inconvenience and an expense to the sponsor.

Reports indicate that as many as 30% of subjects taking part in Phase III clinical trial participation drop out. Gruelling schedules, high travel costs and the time taken to be reimbursed for expenses are all factors in these high drop-out rates and this can cause a trial to be delayed or even cancelled. But as the world begins to stare down a pandemic, thanks to the outstanding work of our scientific community, it’s important to make sure that something as simple as travel restrictions does not slow down the progress.

Franc Jeffrey CEO of EQ Trave

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What it's like to participate in a clinical trial

Once you go through the process of finding a clinical trial you can participate in and the informed consent process for a study, here's what you can expect from participating in a trial.

If you take part in a clinical trial, you may get tests or treatments in a hospital, clinic, or doctor's office. Participants in a clinical trial are often treated in the same way as other patients who aren’t in a clinical trial, but are more carefully monitored and may have more tests done.

Clinical trials take place in doctors’ offices, medical centers, community hospitals and clinics, and veterans’ hospitals around the world. A particular trial may be offered at only one location, but some are conducted at many different hospitals across the world.


"To my surprise the entire experience felt no different from any other hospitalization, or procedure; honestly, it was probably the best care I have ever received in my many years as a patient!"

Chanel White, a patient advocate and scleroderma clinical trial participant

Additional medical tests and monitoring

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One of the main differences between receiving treatment as part of a clinical trial versus standard care is that there might be more medical tests and attention from medical staff as part of a clinical trial.

Before starting the new treatment, members of the study team will usually look through your full medical history. Depending on the trial, you may need to have blood tests, imaging tests, and/or a physical exam done if you haven’t had them recently. These are needed to be sure that you meet the requirements to participate, and to help ensure your safety.

You may also have tests done more often to find out how well the treatment is going, and check on how you’re doing. You’ll likely get more attention as a participant in a trial than you would otherwise. The doctors and nurses may examine you more often and will want to know if you’re having any side effects (also known as adverse events) while being treated.

Because the possible side effects may not fully be established, it’s very important to let the research team know how you're feeling. They can use this information to decide if symptoms you’re having are related to the clinical trial, if you need any special attention, or your treatment needs to be changed.

Safety of participants is strongly regulated by many organizations , and it's important to remember that you can always leave a study at any time, for any reason.

Keeping a health journal during the trial

An overhead shot of a pencil on an open planner next to a cup of coffee

While participating in a clinical trial, you may be asked to write a health journal to record your symptoms, diet, and everyday life. This information can help determine common side effects of the treatment.

If you’re required to keep a health journal during the study, what you need to include will be outlined for you. For example, you may be asked to record side effects and symptoms in more detail than your daily activities. Ask about their expectations for patient journals to make sure you’re recording the right details.

Even if your study isn’t requesting a health journal, having a health journal can help you keep track of your health. Some patients find it helpful to keep a digital health journal on their phone or mobile device. This can speed up the journaling process and also allows you to easily share information with your doctors and nurses.

We recommend choosing a consistent place to take notes, written or typed, that can travel easily or be accessed remotely at your appointments.

What to include in your journal

While each patient’s journal looks a little different, entries usually address similar topics. Recording the date of the entry will help you keep track of patterns in your health. Here is a list of some items you might want to include in your journal:

Details about each appointment (information received, lab work done, procedures and subsequent reactions etc...)

Name and dose of prescribed drugs, especially if it is information that is not immediately available through a paper prescription

A running list of questions, concerns, and comments (what's working, what isn't, etc...)

Time(s) of the day you take your medicine

Diet and timing of meals

Daily activities and exercise

Symptom progression

New or recurring side effects

Changes in mood

Preparing to participate in a trial

There are a number of things that you can start to keep in mind, even before you start participating in a study. Planning around insurance coverage, travel and lodging logistics, and the general schedule changes that come with participation can help you feel ready and will ensure that your entire process runs smoothly.

Your team of researchers and the clinical trial coordinator (in addition to your primary care doctor, your friends, and your family), can all help support you throughout your clinical trial journey to make things easier.

Telling others you're participating

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While participating in your trial, you may want to discuss your trial with your friends, family, and even coworkers. Here’s some advice on how to navigate these conversations.

Talking to friends and family

Discussing your trial with family and friends can be an important step in your journey, as they can provide a strong emotional support system. Letting them know your needs, and ways they can best support you can ensure that you both feel more comfortable.

When you first tell your friends and family about your trial, they’ll probably have a lot of questions. Consider preparing your responses to the following commonly asked questions:

Why are you participating in a trial?

Will there be any side effects or risks in the trial?

How long will the trial last?

How can I help you throughout your trial?

It’s natural for your loved ones to have questions or concerns about the study. Helping them understand the ins and outs of how the FDA, Institutional Review Boards, and trial coordinators ensure patient safety can be a great place to start this conversation.

Finally, some patients also find it helpful to bring a family member or friend to trial appointments. This is just one more way to feel supported through your trial and can make discussing your trial easier.

Informing your employer

First, it’s important to note that you are not obligated to inform your employer. Some patients use vacation days to participate in their trial, and don't find it necessary to inform their workplace. Still, you may decide to inform your employer should you need to request time off from work.

If you decide to inform your employer, let them know that you are enrolling in a clinical trial and may require time off from work. Once you receive your official trial schedule, you'll want to include the start date, end date, and frequency of appointments of your trial, if possible. Also, make sure to review your company’s medical leave policy to determine the pay status and availability of medical leave.

You may find it necessary to outline your reasoning for enrolling in a trial, such as advancing treatment options for others with your condition. It’s best to notify your workplace sooner, rather than later to make coordinating time off from work easier.

Managing your travel and lodging

View from the back seat on a man in glasses driving in heavy traffic

Before enrolling, you should be notified if and how your trial plans to compensate its participants. Make sure to discuss all available travel compensation, because this can be one of the most expensive parts of trial participation. All the different amounts of travel compensation should be included in your Informed Consent Form. Once this form is signed, it is very difficult for researchers to change the terms of compensation, even if there was a mistake.

To get to your clinical trial, you’ll likely have to make travel arrangements for your appointments. Whether that’s driving yourself, taking a taxi, or flying, planning your travel to a clinical trial can be difficult. Here’s some advice for when you're trying to make those plans.

Common forms of reimbursement

Here are some ways researchers compensate for travel:

Prepaid gas cards

Parking vouchers

Taxi and ride sharing vouchers

Airfare credits

It's important to note that not all trials cover patient travel expenses - and even the ones that do may not fully cover your expenses. That’s why it is important to save all necessary receipts for travel costs. Without these, you may not receive reimbursement. Also, medical-related travel is tax deductible, which is another reason you’ll want to keep track of your receipts.

Overnight stays

For overnight clinical trials, you’ll also have to consider where you'll be staying. For some trials, you are able to sleep overnight at the trial site, but for others, you will likely need to stay in a hotel or Airbnb .

Like travel expenses, lodging expenses are sometimes covered by trial sponsors. If this is the case, you may have to pay for your hotel room out of pocket and then be reimbursed for the charges later. Other trials will pay for the room in advance, and you won’t need to get reimbursed.

Even if your lodging expenses are not covered, make sure to save your receipts. As with travel, lodging expenses for medical care are tax deductible.

When packing for an overnight trial, you’ll want to contact your study site; researchers often provide snacks, music, games, basic toiletries, and other items that you won’t need to pack. Here are some common items to make sure you have on hand:

1. Identification and Medical Forms

To start your trial, you’ll most likely need a government-issued photo ID, such as a driver’s license or passport, to check in. Also, make sure to bring all relevant medical information that you may need.

2. Clothes In general, you’ll want to bring comfortable clothing that is relatively light and warm. You should pack one outfit per day you'll be at the trial site and one extra outfit just in case you lose any clothing.

Here's a breakdown for each clothing item:

  • Shirts: flexible and breathable. Dri-fit shirts are an especially good choice, since they wick sweat and keep you warm.
  • Pants: loose-fitting and lightweight. Thin sweatpants and athletic pants should work well.
  • Underwear and socks: comfortable and breathable. Comfort is key here, because you may be sitting for long periods of time during your trial visit.

3. Toiletries

If your study site doesn’t provide toiletries or you want to bring your own, don’t forget to pack all liquids in travel containers to save space.

Here's a list of toiletries you may want to pack:

  • Shampoo, conditioner & body wash
  • Toothbrush & toothpaste
  • Razor & shaving cream

4. Entertainment

You’ll probably want to bring your phone or tablet for communication and entertainment during your stay at the trial site. Also, consider bringing a laptop if you’ll be at the site for several nights. Finally, think about bringing along a good book for some reading during downtime.

Organizing information

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As you go through your trial experience, you will receive a lot of information, and have a busy schedule to keep track of. Planning ahead will help you with keeping track of your progress through the study, and staying on top of your schedule.

We recommend setting up an organizational system before you begin the clinical trial process. It’s helpful to keep all documents in one place (whether they’re electronic or physical), with notes, and a calendar of important dates.

Here’s an outline of useful information to organize, and tips on how to go about doing it.

Documents to keep on file

These are all the things you should have a physical and/or electronic copy of:

Treatment plans


The most current copy of your medical insurance coverage

Insurance claims filed by you, your doctor, or your hospital

Explanation of benefits (EOBs) statements from your insurer

Insurance reimbursements and claim rejections

Appeal letters

Check and credit card receipts

Dates to keep in a calendar

For time specific information, we recommend recording the dates in a calendar format so you can quickly glance at it for reference. Particularly important dates include:

Upcoming medical visits and calls

Treatments received

Communication with insurance (such as the date an appeal was filed)

Medication (time of start and finish)

Additional organization tips

1. File your bills with their corresponding statements Even though you may receive the explanation of benefits (EOB) statement separately from the bill, keeping them together will make cross-checking easy and efficient. To this point, always compare the bill you receive with the EOB statement from your insurance company. Inquire about any differences you might detect between them, and always speak up if you’re concerned your bill is incorrect.

2. Organize in chronological order This one might seem obvious, however, it is hard to predict the amount of documents you'll end up needing to store. Organizing your records in order of when you received them will allow you to easily find a file if you ever need to reference a certain one.

3. Backup your files If you choose to store things electronically, make sure you have a secure backup system in place. Whether it's printed hard copies, a flash drive, or the cloud, have a backup plan in case your computer crashes.

Likewise, if you are keeping paper copies, it would be a good idea to scan them electronically as well.

4. Hire a specialist to help This is, of course, completely optional. That said. health insurance claims assistants exist to provide professional help for dealing with all your insurance records. Their services include filing and keeping track of an unlimited number of claims, reviewing medical bills for accuracy, and appealing rejected claims. If you have a particularly demanding need, these professionals can be an effective resource.

5. Online tool for people on Medicare If you receive Medicare, it is important to know that there is an online tool for storing and accessing your personal information . You can use this resource to help you stay organized!

Finishing up the trial

As you're wrapping up participating in the study, you might have questions about what happens after the clinical trial ends . The end of the clinical trial does not mark the end of all communication between you and the research team. After your exit interviews with the research team to give you a chance to provide feedback on your experiences, you'll typically go back to having the standard care you were receiving before participating in the study. In some cases, you can continue on the study treatment - that and other details about what happens when the trial is over should be covered with you during the informed consent process before you enroll in the study.

The study staff will share details about the findings of the study with participants as soon as possible. If the results are positive, the treatment will become available to all patients as part of standard care.

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Key Cost Drivers in Clinical Research: Guide to Successful Budgeting

It's almost impossible to map out study budgets with absolute precision. Planning for the unexpected costs, such as those associated with slow enrollment, protocol amendments, and other contingencies—is vital.

Proper study budget is vital for a successful trial for both parties, contract research organizations (CRO) and pharma companies. Therefore, it is essential to take the time and prepare your financial plan by thoroughly thinking of all expenses.

So, what does a typical clinical trial budget consist of? First of all, the study budget can be broken into two main big parts: the cost of CRO services, and pass-through costs (PTC).

PTC, for their part, are all the expenses that are passed directly to the Sponsor at actual cost:

  • Site and PI grant fees —grant fees paid to principal investigators and sites for the recruitment of patients; these costs often comprise the most significant part of the study budget;
  • Vendors’ costs —Central Labs, IDMC, depots, ePRO, and any other vendors, if they are subcontracted by the CRO;
  • Comparator and concomitant medication —depending on the study design, purchase, and logistics of these might add up to quite a significant sum that should be planned for in advance.
  • Study supplies, equipment —complexity of study procedures may require specific equipment not usually used at site in routine practice, so there might be a need to purchase it for the study. Sometimes it can be expensive to procure, deliver, and then at the end of the study, collect it from the site.
  • Travel costs, investigator meeting costs —keep in mind that travel costs may also form a substantial part of the budget, depending on the study design and needs (for example, frequency of on-site monitoring visits and site geography). Another important factor to be taken into consideration, especially when planning a multinational clinical study, are currency fluctuations that may influence the cost of travel, which is very hard to predict or plan for.
  • Logistics and courier costs, depot services —these costs do not only depend on the study geography, but on the number of subjects (and, as a consequence—sites) as well. The larger the sample size is, the more medication and biosamples shipments, thus the more expensive the study is. And again, do not forget about currency fluctuations. So, it is imperative that logistics managers help plan the budget as precisely as possible.
  • Regulatory authorities’ fees and patients’ insurance —make sure to include all local RA (as well as LECs—where applicable) fees and patients’ insurance that directly depends on the sample size and on the study phase and local country requirements.
  • Questionnaire license fees —don’t forget about the licensing fees that can be both paid and free of charge. In certain cases, they can be accompanied by considerable costs.
  • Taxes and bank commissions —local specific requirements for taxes and bank commissions vary among countries. So, your partner CRO should be responsible for double-checking that.

Taking a deeper dive into the structure of the CRO service costs we will see the following:

  • Site management and monitoring —one of the highest in the overall structure of service fees, and it may account for the largest part of the clinical study budget. Amount of monitoring (including site initiation visits, interim monitoring visits, and closeout visits) will depend on both the sample size and Sponsor’s requirements towards SDV (Source Data Verification) percentage.
  • EDC, data management and biostatistics —in general, data management costs strongly depend on the number of patients and sites. Another powerful cost driver for the cost of these services, is the complexity of CRF (which, in turn, depends on the amount of study procedures) as well as the duration of the study.
  • Project management —the cost of project management (PM) depends on study duration and complexity (including number of sites, countries and specific vendors involved). And even though there is no direct connection between the number of subjects and cost of PM, if the increased number of subjects requires involvement of additional sites or even countries—this of course will add to the project management cost.
  • RA support/CTA submission —geography definitely has an impact on the cost of regulatory support services, as the duration of clinical trial approval and the CTA process itself varies (sometimes significantly) from country to country. Different countries and regions may have their own requirements for submission packages and sometimes it can be a challenge to put everything together. For instance, in Russia, the package is relatively easy to collect as it is similar to what EMA and FDA require, but all documents should be translated into Russian language, which takes time and some additional costs. In Ukraine, the package is also simple, as they EU CTA for initial submission and EU requirements (for example, submission of complete IMPD for IMP), but the Ministry of Health requires a lot of documents from investigators, not only principal investigators. Accreditation and certification of each medical institution involved in the trial have to be collected and reviewed for validity. Of course, collection of such packages takes more time and costs are higher with respect to the services. Meanwhile, there is no need in full translation of study core documents into Ukrainian.
  • Medical writing —even though the cost of services connected with medical writing, and CTA package preparation are normally lower than other project costs, it is hard to overestimate the importance of biostatisticians’ and medical writers’ work - both experts’ decisions regarding study approval and the efficiency of the clinical trial depend directly on properly and expertly prepared study design.
  • Logistics —when we say “logistics” here, we are talking about CRO support in coordinating the import and shipments of investigational drugs, study supplies, concomitant or comparator medications, biosamples (while the cost of those shipments are pass-through costs, described above).
  • Pharmacovigilance and quality assurance —quality assurance costs spent on maintenance of QA and QC systems, training and audit expenses, as well as PVG, even though highly important, usually comprise a smaller part of the overall study budget.

What if out-of-scope happens?

However, contingencies are hard to avoid in real life, therefore it is necessary to be ready to face the out-of-scope. So, how to find ways to effectively manage it? Indeed, with large-scale international studies, especially in the long term, it is almost impossible to map out study budgets with 100% precision. The majority of companies have all the responsibilities of project managers or those of other project-related specialists listed in their SOPs and project management plans. What is more, take a tip from insiders—if a project manager not only presents an issue of out-of-scope to Sponsor, but also comes up with a possible solution within the current study budget, it will be clear evidence of his professional competence and individual approach to clients. There might be some internal monetary resources if you look into the budget carefully. For example, depending on how the enrollment goes at each site, you can adjust monitoring frequency and extend the break between visits but make them longer. This is an opportunity to cut back on travel costs which, in case of big countries like Russia, might be quite significant. Besides, the CRO service cost for a two-day monitoring visit will be lower than two one-day visits, as the CRA will not have to spend additional time travelling to site. One more thing which can help avoid out-of-scope situations is an accurate and detailed budget grid. For example, the budget template of OCT Clinical CRO consists of over 400 items and covers all the tasks that will be done for a particular project, which provides maximum transparency and reduces the risks of hidden costs. Planning for the unexpected, such as costs associated with slow enrollment, protocol amendments, additional IMP imports and other contingencies—is, indeed, of paramount importance.

Irina Petrova , MD, is the Director of Clinical Operations,  OCT Clinical ​

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Boeing accepts plea deal to avoid criminal trial over 737 Max crashes

B oeing will plead guilty to a criminal fraud charge stemming from two crashes of 737 Max jetliners that killed 346 people, the Justice Department said late Sunday, after the government determined the company violated an agreement that had protected it from prosecution for more than three years.

Federal prosecutors gave Boeing the choice last week of entering a guilty plea and paying a fine as part of its sentence or facing a trial on the felony criminal charge of conspiracy to defraud the United States.

Prosecutors accused the American aerospace giant of deceiving regulators who approved the airplane and pilot-training requirements for it.

The plea deal, which still must receive the approval of a federal judge to take effect, calls for Boeing to pay an additional $243.6 million fine. That was the same amount it paid under the 2021 settlement that the Justice Department said the company breached. An independent monitor would be named to oversee Boeing's safety and quality procedures for three years. The deal also requires Boeing to invest at least $455 million in its compliance and safety programs.

The plea deal covers only wrongdoing by Boeing before the crashes in Indonesia and in Ethiopia, which killed all 346 passengers and crew members aboard two new Max jets. It does not give Boeing immunity for other incidents, including a panel that blew off a Max jetliner during an Alaska Airlines flight over Oregon in January, a Justice Department official said.

The deal also does not cover any current or former Boeing officials, only the corporation. In a statement, Boeing confirmed it had reached the deal with the Justice Department but had no further comment.

In a filing Sunday night, the Justice Department said it expected to submit the written plea agreement with a U.S. District Court in Texas by July 19. Lawyers for some of the relatives of those who died in the two crashes have said they will ask the judge to reject the agreement.

“This sweetheart deal fails to recognize that because of Boeing’s conspiracy, 346 people died. Through crafty lawyering between Boeing and DOJ, the deadly consequences of Boeing’s crime are being hidden,” said Paul Cassell, a lawyer for some of the families.

Federal prosecutors alleged Boeing committed conspiracy to defraud the government by misleading regulators about a flight-control system that was implicated in the crashes, which took place than less five months apart.

As part of the January 2021 settlement, the Justice Department said it would not prosecute Boeing on the charge if the company complied with certain conditions for three years. Prosecutors last month alleged Boeing had breached the terms of that agreement.

U.S. District Judge Reed O'Connor, who has overseen the case from the beginning, has criticized what he called “Boeing’s egregious criminal conduct.” O'Connor could accept the plea and the sentence that prosecutors offered with it or he could reject the agreement, likely leading to new negotiations between the Justice Department and Boeing.

The case goes back to the crashes in Indonesia and in Ethiopia. The Lion Air pilots in the first crash did not know about flight-control software that could push the nose of the plane down without their input. The pilots for Ethiopian Airlines knew about it but were unable to control the plane when the software activated based on information from a faulty sensor.

The Justice Department charged Boeing in 2021 with deceiving FAA regulators about the software, which did not exist in older 737s, and about how much training pilots would need to fly the plane safely. The department agreed not to prosecute Boeing at the time, however, if the company paid a $2.5 billion settlement, including the $243.6 million fine, and took steps to comply with anti-fraud laws for three years.

Boeing, which blamed two low-level employees for misleading the regulators, tried to put the crashes behind it. After grounding Max jets for 20 months, regulators let them fly again after the company reduced the power of the flight software. Max jets logged thousands of safe flights and orders from airlines picked up, increasing to about 750 in 2021, about 700 more in 2022 and nearly 1,000 in 2023.

That changed in January, when a panel covering an unused emergency exit blew off a Max during the Alaska Airlines flight over Oregon.

Pilots landed the 737 Max safely and no one was seriously injured, but the incident led to closer scrutiny of the company. The Justice Department opened a new investigation, the FBI told passengers on the Alaska plane that they might be victims of a crime and the FAA said it was stepping up oversight of Boeing.

A criminal conviction could jeopardize Boeing’s status as a federal contractor, according to some legal experts. The plea announced Sunday does not address that question, leaving it to each government agency whether to bar Boeing.

The Air Force cited “compelling national interest” in letting Boeing continue competing for contracts after the company paid a $615 million fine in 2006 to settle criminal and civil charges, including that it used information stolen from a rival to win a space-launch contract.

The company based in Arlington, Virginia, has 170,000 employees and dozens of airline customers spanning the globe. The best customers for the 737 Max include Southwest, United, American, Alaska, Ryanair and flydubai.

But 37% of its revenue last year came from U.S. government contracts. Most of it was defense work, including military sales that Washington arranged for other countries.

Boeing also makes a capsule for NASA. Two astronauts will remain at the International Space Station longer than expected while Boeing and NASA engineers troubleshoot problems with the propulsion system used to maneuver the capsule.

Even some Boeing critics have worried about crippling a key defense contractor.

“We want Boeing to succeed,” Richard Blumenthal, a Connecticut Democrat, said during a Senate hearing last month on what he termed the company’s broken safety culture. “Boeing needs to succeed for the sake of the jobs it provides, for the sake of local economies it supports, for the sake of the American traveling public, for the sake of our military.”

Relatives of the Max crash victims have pushed for a criminal trial that might illuminate what people inside Boeing knew about deceiving the FAA. They also want the Justice Department to prosecute top Boeing officials, not just the company.

“Boeing has paid fines many a time, and it doesn’t seem to make any change,” said Ike Riffel of Redding, California, whose sons Melvin and Bennett died in the Ethiopian Airlines crash. “When people start going to prison, that’s when you are going to see a change.”

At a recent Senate hearing, Boeing CEO David Calhoun defended the company’s safety record after turning and apologizing to Max crash victims’ relatives seated in the rows behind him “for the grief that we have caused.”

Hours before the hearing, the Senate investigations subcommittee released a 204-page report with new allegations from a whistleblower who said he worried that defective parts could be going into 737s . The whistleblower was the latest in a string of current and former Boeing employees who have raised safety concerns about the company and claimed they faced retaliation as a result.

Koenig and Richer write for the Associated Press

This story originally appeared in Los Angeles Times .

Boeing accepts plea deal to avoid criminal trial over 737 Max crashes


Medical Visas for Clinical Trial Travel: What Patients Should Know

The U.S. and many other countries have various types and requirements when it comes to visas for international visitors. The type of visa required often depends on the nature of travel – whether it is for business, tourism, or if it’s related to medical care. The Visa Waiver Program (VWP), also referred to as Electronic System for Travel Authorization (ESTA) permits citizens of 38 countries to travel to the U.S. for business or tourism for stays up to 90 days. Countries that have adopted the VWP have a reciprocal agreement to allow U.S. citizens and nationals to travel to their countries for a similar length of time for business or tourism without a visa. The ESTA is an online application that needs to be completed by the traveler prior to the date of departure. The cost of the ESTA is approximately $15 USD.

This may sound daunting to someone who is traveling in order to receive medical care or participate in a clinical trial. Clinical trials often require extended stays, sometimes beyond 90 days. Luckily, there is an alternative option for those travelling to the U.S. to participate in a clinical trial. If there is the possibility of an extended stay beyond 90 days, or travel is from a country not in the VWP/ESTA program, then it is recommended that the traveler obtain a B2 medical visa. In the ever-changing political environment regarding immigration in the U.S., it is important to obtain the correct visa.

The application process for the B2 visa

The application process for the B2 visa can be lengthy and involved, and the timeline is subject to how quickly potential applicants can provide their information. A few of the requirements needed include a medical letter describing the trial, the diagnosis and treatment for the applicant and how they will financially support themselves during their trial participation. In addition, there is a detailed questionnaire that all applicants must complete that will require personal information such as: evidence of home ties (like an employer letter), utility bills for up to 12 months, deed of property ownership, past visas and other proof of ties to their home country. Once the application is complete, and assuming the applicant has a valid passport, an in-person interview is scheduled at the traveler’s local consulate or embassy. Wait times vary by location and can be as short as 5 days or long as 18 days or more. The whole process from start to finish can take up to the 3 months.

Once the B2 visa is granted it becomes the entry ticket to the U.S. and will allow for multiple trips to the U.S. for the validity of the visa. It’s important to note that visa validity and admission period are completely separate. Depending on the country, most visas are valid between 5 to 10 years, but for a few countries, validity may only last 1 year. The admission period is determined each time a foreign national enters the U.S. and normal admission for the U.S. is 6 months. Extensions are available in 6 month increments.  While there is no limit to the number of extensions one can apply for, the adjudicating officer always has the discretion whether to approve or not.

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Hezly Rivera of Oradell, NJ makes U.S. Olympic gymnastics squad

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Hezly Rivera of Oradell made the U.S. Olympic gymnastics squad late Sunday evening, joining Simone Biles, Suni Lee, Jordan Chiles and Jade Carey ― four athletes who were also on the team for the Tokyo games in 2021.

Joscelyn Roberson and Leanne Wong will travel to Paris in July as alternates.

Rivera, who is the youngest member of the team at age 16, has earned two first place all around finishes as a junior at national competitions, most recently at the 2023 U.S. Gymnastics Championships in San Jose, California. She took another all-around at the 2023 Winter Cup.

PARIS OLYMPICS: When are Opening Ceremonies? Your questions answered

In 2024 at the Winter Cup, she finished third in the all around, but grabbed a gold medal on the balance beam.

When the team was announced after the trials ended in Minneapolis, Rivera said she was "ecstatic" about making the team and credited her family and the sacrifices she and other have made to achieve this goal.

Men's U.S. Olympic gymnastic team

The men's gymnastic team is also set, with  Frederick Richard , Brody Malone, Paul Juda, Asher Hong, Stephen Nedoroscik and alternates Shane Wiskus and Khoi Young going to Paris.

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Getting the most out of public transportation

Tuesday, 09 Jul 2024

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Tour de France stage 7 time trial start times

GC shake up expected once 174 riders complete 25.3km race against the clock from Nuits-Saint-Georges to Gevrey-Chambertin

World Champion in the time trial Remco Evenepoel (Soudal-QuickStep)

Start times CEST

The first of two individual time trials at the 2024 Tour de France takes place on stage 7 , a 25.3km route from Nuits-Saint-Georges to Gevrey-Chambertin, and it is expected to rearrange the general classification after a pair of sprint stages left the top 10 undisturbed with Tadej Pogačar (UAE Team Emirates) in command.

The race against the clock is an opportunity for second-placed Remco Evenepoel (Soudal-QuickStep) to flash the rainbow stripes and make a dent in a 45-second deficit to Pogačar in the GC standings .

Reigning time trial Olympic champion Primož Roglič (Red Bull-Bora-Hansgrohe) is 1:14 back in fifth overall and will use the opportunity to carve away at his fellow Slovenian’s race lead. Expect a strong showing from two-time Tour champion Jonas Vingegaard (Visma-Lease a Bike), who won the Tour’s hilly time last year on stage 16. He is currently third overall, 50 seconds back.

Watch for USA’s Matteo Jorgenson (Visma-Lease a Bike) to take advantage of the undulating course to make a jump into the top 10. Currently 11th overall in a group of four riders 3:21 behind the race leader, Jorgenson finished fourth in the ITT at Critérium du Dauphiné and then used podiums in two climbing stages to finish second overall in that Tour tuneup.

While there is a climb across the route, a rise that averages 6.1% across 1.6km through Reulle-Vergy to Curley, it comes at the mid-point of the race, so it provides any lost momentum to be regained on the 10.9km remaining to the flat finish.

Mark Cavendish , followed by his Astana-Qazaqstan teammate Michael Mørkøv, will lead the process of 174 riders down the start ramp, beginning at 13:05 local time. 

The top 10 riders take the course from 16:42 to 17:00, with two-minute intervals. There are three time checks along the route, the first before the climb in Mesanges after 8.6km, the second at the crest of the climb at 14.4km and a third on Morey-Saint-Denis with 6.4km to race.

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Organisers estimate the winning time to be in the 29-minute range, so be sure to be tuned into Cyclingnews' live report for all of the updates before the winner is decided.

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Jackie has been involved in professional sports for more than 30 years in news reporting, sports marketing and public relations. She founded Peloton Sports in 1998, a sports marketing and public relations agency, which managed projects for Tour de Georgia, Larry H. Miller Tour of Utah and USA Cycling. She also founded Bike Alpharetta Inc, a Georgia non-profit to promote safe cycling. She is proud to have worked in professional baseball for six years - from selling advertising to pulling the tarp for several minor league teams. She has climbed l'Alpe d'Huez three times (not fast). Her favorite road and gravel rides are around horse farms in north Georgia (USA) and around lavender fields in Provence (France), and some mtb rides in Park City, Utah (USA).

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7 warnings in effect for 11 counties in the area

‘game changer’: vaccine developed at university of houston to end fentanyl overdoses headed for human clinical trials.

Brittany Taylor , Senior Digital Content Producer

HOUSTON – A vaccine that was developed at the University of Houston to prevent fentanyl deaths has been licensed by a new medical startup and will head for human clinical trials, according the the university.

OVAX Inc. raised $10 million to commercialize research from the lab of Colin Haile, a research associate professor of psychology at UH and the Texas Institute for Measurement, Evaluation and Statistics (TIMES), and a founding member of the UH Drug Discovery Institute.

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The vaccine, named Fentanyl Armour, prevents the drug from reaching the brain, thus eliminating the drug’s “high.” When developing the vaccine, Haile and his team called it a “game changer” in the war on fentanyl.

“We believe Fentanyl Armour could have a significant impact on a very serious problem plaguing society for years – opioid misuse,” Haile said.

Fentanyl is 50 times more potent than heroin and illicit fentanyl kills approximately 200 Americans every single day, according to studies. Fentanyl is now weaponized and hidden in drugs like cannabis, counterfeit pills, cocaine, heroin, meth, and even altered nicotine vapes.

  • ‘We’ve made great progress’: UH scientists who created anti-fentanyl vaccine step closer to becoming FDA-approved

OVAX said it plans to begin human trials of Fentanyl Armour early next year.

“This breakthrough discovery could have major implications for the nation’s opioid epidemic by becoming a relapse prevention agent for people trying to quit using opioids,” Haile said.

While research reveals Opioid Use Disorder (OUD) is treatable, an estimated 80% of those with this disorder eventually relapse.

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Brittany taylor.

Award-winning journalist, mother, YouTuber, social media guru, millennial, mentor, storyteller, University of Houston alumna and Houston-native.


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