Why Should You Consider Participating in Diabetes Research?
By Nicole Kofman and Alexander Wolf
Twitter Summary: Clinical trials need more participants. Why should you get involved?
One in seven Americans now has diabetes. That means in an average room of 100 people, 14 will have diabetes. Take that same room in 2050, and some estimates indicate that as many as 33 people would have diabetes. We need more prevention, better treatments, and ultimately a cure.
Studies are necessary to accomplish those goals, but one major challenge for researchers is finding people to participate. In this piece, we talk to leading diabetes researchers on why research is so critical, the benefits for patients, and ways to get involved.
Note: Before enrolling in any study, please discuss the pros and cons carefully with a healthcare provider. Studies vary in their potential risks and benefits.
Background
A century ago, doctors and scientists had no universally established methods for determining how effective medical treatments were. While modern, controlled research trials date back as far as 1747, a major milestone came in 1946 with the first randomized "curative" clinical trial. The concept of randomization, in which people are randomly assigned to a “treatment” group and a “control” group to compare the results between the two, was originally introduced to clinical research in 1923. This model was quickly adopted as the basis of clinical research, setting the stage for the continued development of the field.
Over time, regulatory guidelines were introduced to protect participants. These rules include, but are not limited to, obtaining informed, voluntary consent from participants and terminating the study if it has demonstrated more harm than benefit. Today, institutional review boards (IRBs) perform ethical reviews of proposed research, with the goal of protecting the participants. Independent Data Monitoring Committees, groups of experts with no relation to a trial's researchers or its sponsors, also supervise clinical trials to ensure the ongoing safety of study participants.
Challenges in research trials
While clinical research is vital for advancing scientific and medical discovery, it is also challenging for several reasons. Funding is always pressing, particularly for younger scientists, as public and private dollars for new research in diabetes is not meeting needs.
Recruiting participants can often be a close runner-up for the most significant challenge in research. According to Tufts, up to two-thirds of clinical trial locations fail to meet patient recruiting requirements. Dr. Desmond Schatz, president-elect of the ADA, told us that research is hampered by patient recruitment, which leads to higher costs, longer trials, fewer trials, and slower progress for the field. This is de-motivating for sponsors to fund researchers, and de-motivating for researchers to work in diabetes.
Why is it hard to enroll patients in trials?
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Access and inconvenience: USC endocrinologist Dr. Anne Peters shared that access to healthcare can be a hurdle for many patients to participate in research. Several issues can come up: Does a trial require participants to take time off of work or away from their families? Is it easy for people to get to the trial centers? Many trials struggle to recruit patients from minority ethnic and racial backgrounds, which makes it difficult to recruit a patient group that realistically represents people living with diabetes. Dr. Peters has addressed this problem by using a van to pick up patients who otherwise wouldn’t have transportation, and providing daycare for the children of her patients who otherwise wouldn’t be able to have time to participate in her trials.
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Fear of risks: Patients may also be deterred by the risk that inherently comes with many clinical trials, particularly those investigating a new drug or treatment. The goal of many clinical trials is to evaluate if a drug is safe, meaning participants enter trials knowing the drug might possibly lead to undesirable and unexpected consequences.
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Lack of understanding and awareness: Ms. Davida Kruger, previous Chair of the ADA Research Foundation, said that often people aren’t fully informed about the potential benefits of clinical trials. Moreover, according to the NIH, as many as 85% of people are unaware that clinical trials could be an option for them when diagnosed with a disease.
Benefits of participating in research
In a global survey of over 5,000 people on perceptions of clinical trials, 33% of respondents said “advancing science and treatment” is the top perceived benefit of clinical research, and 29% said to “help or improve lives.” In addition to these big-picture benefits, there are several near-term reasons people may consider participating in research.
According to Dr. David Wendler, Head of Research Ethics at the NIH, people in research studies often receive better care than those who receive standard clinical care, since they are often cared for by some of the top researchers in their field at leading centers. The fact that studies are designed to collect data does not imply that they are worse than standard care – often they are far better.
Additionally, he argued that in the same way that volunteering for a charity can be emotionally beneficial for someone, participating in research can be seen as an effort to help others, resulting in a “more valuable, meaningful, and interesting life.”
Dr. Anastasia Albanese-O’Neil discussed enrolling her own daughter in type 1 trials at this year’s CWD Friends for Life. Dr. Albanese-O’Neil mentioned how participating in research pays it forward to the next generations of people with diabetes. After all, without the thousands of people who had participated in trials before her daughter was diagnosed, she would not have new insulins, pumps, CGMs – all the things she relies on every day. Dr. Albanese-O’Neil also wants her own daughter, now 16, to have the best possible chance in life with the least burden. “Other people can’t do it for us,” she says referring to research, and “time is of the essence.”
Lastly, trial participants are often compensated for their time, providing some financial benefit. It’s hard to get rich off research – especially given time off of work – but compensation does help.
How can you get involved in research?
1) Use Online Resources to Find Clinical Trials
We’ve compiled a list of reliable websites that may be helpful in locating a research study near you:
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Trial watch on the diaTribe website makes it easier to understand clinical trials listed on government websites, making it clear what the trial is testing, why it’s important, it’s length, location, and more.
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Trial reach is a new initiative to make it easier to search for trials nearby one’s home that they might qualify for and benefit from.
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Registries and databases such as clinicaltrials.gov, NIH, and Diabetes Trial Net all are good places to find research opportunities.
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Type 1 Diabetes Exchange is an organization committed to “mitigating barriers and inefficiencies for clinical research” to improve outcomes for people with diabetes. It runs the Glu online community, which aims to accelerate research by connecting patients.
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ResearchMatch asks basic questions about yourself and your health background and then allows researchers who think you will be a good match for their study to contact you.
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JDRF Clinical Trials Connection helps people understand what is involved with participating in type 1 diabetes clinical trials and simplifies the process of finding trials.
2) Talk To Your Doctor
Here is list of questions from the National Institute on Aging to potentially discuss with a healthcare provider or the research team itself regarding clinical trials:
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What is the purpose of the study? What is this study trying to find out?
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What will I have to do as a participant?
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What treatment or tests will I have? Will they hurt?
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What are the chances I will get the experimental treatment?
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What are the possible risks, side effects, and benefits of the study treatment compared to my current treatment?
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How will I know if the treatment is working?
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How will you protect my health while I am in the study?
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What happens if my health problem gets worse during the study?
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How will the study affect my everyday life?
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How long will the clinical trial last?
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Where will the study take place? Will I have to stay in the hospital?
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Will you provide a way for me to get to the study site if I need it?
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Will being in the study cost me anything? If so, will I be reimbursed? Will my insurance cover my costs?
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Can I take my regular medicines while in the trial?
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Who will be in charge of my care while I am in the study? Will I be able to see my own doctor?
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Will you follow up on my health after the end of the study?
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Will you tell me the results of the study?
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Whom do I call if I have more questions?
Special thanks to Cara Dartnell-Steinberg and Lizzie Lacy for their research and contribution to this piece.
