Picture this: you sign up for a clinical trial testing a new medication, perhaps because you want to help advance Parkinson’s disease (PD) research.
You learn that as part of the trial, you have to spend one weekend a month at a major medical center, which is a three-hour drive away. You are unable to drive so your spouse or care partner has to come with you, missing a day at work. But the study will not cover the out-of-pocket expenses you incur for gas, tolls, or hotel — not to mention that lost day at work.
What do you do? If you are like most of us, you might decline to participate in the study. In a small survey PDF conducted recently among a group of volunteer Research Advocates, one in four respondents told us that they have declined to be a part of a clinical study because it did not offer travel reimbursement.
This poses a challenge for all of us, and for the future of Parkinson’s drugs. If people are not signing up for trials for financial reasons, then those trials will take longer to complete. Longer trials, in turn, result in higher costs for the manufacturers, and most importantly, delays for the people with Parkinson’s who are hoping for new and better treatments.
At PDF, we work to identify the obstacles that are delaying better treatments, and then to implement strategies to overcome them. In this new series, “What’s Delaying New Drugs?” we’ll be sharing with you the obstacles we have identified since we began our research advocacy program almost a decade ago, and then letting you know what we are doing to solve them — and how you can help. Our first topic is the matter of travel reimbursement.
A Complicated Issue
Do the sponsors of drug trials routinely reimburse travel expenses? If so, what type of costs will they typically cover? And if lack of adequate reimbursement is a significant reason for why recruitment takes so long and trials are delayed, what can we do to fix it?
The answers vary greatly. In some clinical trials, such as those sponsored by the National Institutes of Health (NIH) in its own facilities in Bethesda, MD, participants can show proof of travel costs, and be reimbursed for some or all out-of-pocket expenses. But in PDF’s survey, an astonishing 58 percent of respondents who traveled to and from a study site over a two-year period reported that they received no form of travel reimbursement. For the 42 percent that did receive reimbursement of some kind, the most common expenses covered were for meals, parking and gas or mileage.
Why don’t all the trial coordinators reimburse legitimate expenses? In some cases, sponsors or scientists may not have funds in their budget to reimburse for travel. In other cases, sponsors say they would like to offer reimbursement, but the boards that oversee the ethics of studies, called Institutional Review Boards (IRBs) may discourage or reject the request to reimburse, on the grounds that reimbursement could be interpreted as a form of coercion. In yet other cases, the coordinators running clinical studies may not be aware that lack of travel reimbursement is the reason people are not signing up. We cannot point the finger at one person or institution for creating this problem; there may in fact be many reasons. And each one may require its own solution.
What Can Be Done?
PDF, through its network of more than 230 PDF Research Advocates, is using several strategies to understand and solve the problem. And you can help.
First, we are collaborating with scientists at four leading institutions in the US to examine transportation reimbursement and other barriers to research. These institutions are all recipients of the first crop of Leadership Awards through the program we call Parkinson’s Advocates in Research (PAIR). A condition of the award, each of which carries a grant of $5,000 to establish a formal collaboration between scientists and patient advocates, is that study sponsors discuss travel reimbursement and other barriers with PDF Research Advocates and subsequently develop solutions.
Second, we will be redoing the original pilot survey on a wider scale, requesting feedback on travel reimbursement from people with Parkinson’s and care partners across the US. If you have participated in a clinical study in which travel reimbursement has been an issue — positive or negative — please share your experiences with us at www.pdf.org/travel14.
Lastly, we are making a special effort to support the work of our Research Advocates who are tackling this issue locally. Below, see examples of their inspiring work.
We all want better treatments for Parkinson’s at a faster pace. And while many factors are delaying new drugs, including transportation costs, there are solutions for each one. Together, we can all make a difference in overcoming those obstacles and come closer to our ultimate goal: a cure for Parkinson’s disease.
How PDF Research Advocates Are Helping to Remove Roadblocks to Drug Development by Transporting Volunteers to Trials
PDF Research Advocate Steve DeWitte of New Preston, CT, told us a few years back, “When I ask people with Parkinson’s why they are not involved in PD studies, many reply, ‘Because I have no transportation.’” His solution was launching the Clinical Trial Transportation Program (CTTP). By partnering with Beth Israel Deaconess Medical Center in Boston, MA, and Columbia University Medical Center in New York, NY, CTTP has helped 37 volunteers to participate in studies by driving them to these two medical centers.
PDF Research Advocate Ken Reck of Chicago, IL, saw the same issue in his community. So he asked Lucy Blasucci, R.N., program coordinator at the PDF Research Center at Rush University Medical Center in IL, if he could serve as a volunteer driver for those unable to get to trials. So far, he has provided transportation for two participants, driving them to Rush twice a month. Ms. Blasucci, said, “Ken realized what’s really important in research — people. You can have all the money in the world, but you can’t do anything without people volunteering for trials. Ken is a prime example of how one individual really can make a difference.”
PDF Research Advocate Carolyn Weaver of Freeland, MI, knew back in 2008 that a clinical trial at the NIH in Maryland needed more volunteers. But instead of asking friends to travel, she thought, “Why not bring the trial to the people?” She invited scientists from the NIH to travel to her home state and recruited 43 people with PD and loved ones to participate. They all completed the clinical study that day! In addition, she provided transportation (a donated bus) for many of those participants, some of whom traveled from as far as 100 miles away.
PDF Research Advocates Marilyn and Jay Phillips of Charleston, SC, thought if travel is so difficult, why not let people participate in trials remotely? They are helping to study the potential role of telehealth, which would allow people to participate in trials using their computers to see and talk to scientists from home. So far, they have helped PDF medical advisor, Christina Vaughan, M.D., of the Medical University of South Carolina, to recruit 17 people to her Parkinson’s telehealth study. As Marilyn said, “Enabling people to volunteer for trials remotely will encourage greater and more diverse enrollment.”