The Clinical Trial Accessibility Checklist: How Does Your Organization Measure Up?
7 Actions Biopharma Can Take To Create A More Accessible Environment For Clinical Trial Participants
This year marks the 30th anniversary of the NIH revitalization act that required women and minorities to be included in clinical research in the US. Putting that into perspective, we have only really been collecting data at scale on women and minorities since the movie Jurassic Park was launched. If we want more people to participate in clinical trials, it is time to get real about reducing the burden of research on volunteers.
Here are seven pragmatic actions the biopharma sector can take today to create a more accessible environment for clinical trial participants.
Remuneration: We can pay clinical trial participants more. The amount that participants are paid varies greatly, from nothing or a small stipend per visit, to up twenty-thousand per year. This payment can help reduce the burden of participating in research, opening the door for a wider segment of the population to get involved. Everyone in a study should get the same payment. While there are no hard limits set on remuneration to a participant and their caregiver, an institutional review board (IRB) must approve that the amount does not cause undue influence or coercion.
Pre-Pay Expenses: It is no longer acceptable to expect people to pay upfront for transportation, flights, hotels, gas, meals, child-care and parking while taking time away from work to participate in research. We can reimburse more, and do it better. Reimbursement is not considered taxable income. And prepayment of expenses is not considered taxable income if the participant provides receipts within a reasonable time. Companies can provide gas cards, parking vouchers, uber credits and meal cards. This pre-payment and direct payment lowers the hurdles to participating in research, and enables more people to get involved.
Cover More: The hidden cost to participating in research varies by study. Depending on the research, studies can offer access to groceries or nutritional meal delivery services. Studies that require women not to be pregnant should reimburse birth control. If the study requires digital engagement, include access to Wi-Fi and cell phone services. If the study is using a platform to find and collect a person’s health data, give the participant access to the platform at no cost. When studies require the support of a caregiver to help the participant make it to appointments, reimbursement should be provided to them also.
Study Design: Make the study protocol less burdensome. Before finalizing a clinical trial protocol, have it checked by experts to see if it can be made easier for participants. Can some visits be combined? Is every test required? Can you accomplish the same goals while making the study a little easier for the volunteers? Often studies are complex, so adding in this step to prioritize the participant experience can make a big difference.
Home Study Option: It is no longer necessary to restrict clinical trials to specific academic medical centers or study sites. Some or all of the trial visits can come to the participant, or even be done virtually. Mobile research centers, home research teams, clinics and telehealth services can bring the research to the volunteer, instead of requiring long drives, flights, hotels and the burden of travel.
Share Results And Credit: Industry should give credit where credit is due. Without research volunteers, we would not have clinical trials. When a study ends, provide a letter of appreciation to each participant from the sponsor and principal investigator. Share information about what is happening with the study data. Will it be presented at an upcoming congress? If yes, share the abstract or a video recording with the investigators. If the data is published, share the publication. If that publication is quoted in another publication, share it also. As long as the data is being used for advancements, continue to update the study participants so they can see the breadth of their impact over time.
Partner Better: Stop calling the people that participate in research “subjects.” These are volunteers choosing to help make the world better for others. Call them volunteers, participants or partners.
These seven actions are doable now. Study sponsors, clinical research organizations, institutional review boards and patient advocacy organizations can take action immediately. But in the future, industry can do more. Here is a wish-list of things leaders in the sector can prioritize.
Stop Taxing Research Stipends
The current guidelines allow for $600 per year in clinical trial payments before it is considered taxable. It is time to stop taxing research stipends and instead, provide tax credits for research participation. If you can get a tax credit for making a donation to a non-profit, you should certainly get one for making a donation to the future of science and the well-being of humanity.
In the US, 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. This is good but we can do more. Let’s remove the cap so volunteers can participate more fully in research without worrying about their eligibility for benefits.
Today, when the study is over, the sponsor will no longer provide the study drug. For participants that volunteered for the study, this can be devastating. It is time for regulators and sponsors to solve this. It is not rocket science. Find a way to ensure that individuals who volunteered to test a treatment can continue to access it, and importantly, can also afford access to it.
ClinicalTrials.gov is an important hub for research but we can make it much easier for people to match with studies. The process of finding people that meet the criteria for a study and are willing to participate is a significant hurdle for developers and patients. It is time for clinicaltrials.gov to upgrade their matchmaking capabilities. It is technically doable and has the potential to expand both the access and the speed of research.
At the end of the day, if we want new treatments for our loved ones and ourselves, for our society and our world, we need more people from all backgrounds to be able to participate in research. And that is a problem we cannot wait another thirty years to solve.
About The Author
Jessica Federer is a board member and investor for companies improving research and care. She was previously chief digital officer at Bayer AG, and has experience across the pharmaceutical industry. Jessica has been passionate about clinical trial participation since she was a student intern at the Office for Human Research Protection in the Department of Health and Human Services. She served on her first institutional review board during graduate school, then known as the Yale Human Investigations Committee, where she continues to serve today. She chairs the NYSE Women’s Health Investor Summit, and co-chairs the SCOPE Clinical Trial Partnering Summit and the DIA Digital Acceleration Community. Jessica shared these actions at the Rock Health Member Forum on September 28, 2023.