The development of new therapies to treat diseases, including inflammatory bowel disease (IBD), isn’t possible without clinical research. And clinical trials are at the core of this research. Clinical trials help us understand more about a potential treatment or drug, such as side effects, safety, and if the drug works for a particular disease (efficacy). Clinical trials also help us understand if a drug works better than others that are already available.
Unfortunately, clinical trials often don’t represent the real-world diversity of patients with IBD and other diseases.(1) This lack of diversity may present challenges for determining the safety and efficacy for patients regardless of sex, race, ethnicity, age, or genetic background. Continuing with the current state of clinical trials fails both patients and their health care providers (HCPs) and deepens the existing health inequities experienced by underserved communities.
Health inequity occurs when groups of people experience differences in the way they receive health care. This may impact disease diagnosis, treatment offerings, and receipt of equitable services.
The pharmaceutical industry acknowledges that there is mistrust of clinical research because of historical events and societal inequities, particularly within health care. Clear and open communication from those involved in clinical research, including the pharmaceutical industry, is needed to move forward. The pharmaceutical industry recognizes its responsibility and has increased its efforts to understand the issue and take actionable steps to make clinical trials more diverse, equitable, and inclusive.
The lack of diversity and inclusion in clinical trials is one of many barriers to health equity. Data show that minority patients with chronic diseases are more likely to be undiagnosed or experience a longer time to diagnosis, which may result in more severe disease and at times poorer health outcomes.(2-4) These patients may also face reduced access to equitable health care, socioeconomic disadvantages, lower rates of insurance coverage, and unconscious bias from HCPs.(2-4) These barriers contribute to the lack of diversity in clinical trials that we see today.
Access, awareness, and education are 3 areas that can drive change. For example, to improve access, clinical trials should be conducted in more diverse communities and in local clinics (rather than in large academic medical centers). Partnering with community HCPs (not typically involved in clinical research) and trusted community leaders helps increase awareness about ongoing clinical trials. People can be empowered through education about clinical trials to address their concerns, inform them of what to expect during a clinical trial, and clearly explain the possible risks and benefits of participation. This will allow them to make an informed choice about whether to participate in clinical trials.
One way for people to learn more about clinical trial opportunities is to visit ClinicalTrials.gov, an online database that can be searched using key words for any disease, such as IBD. By searching the site, patients can review information for trials that are currently recruiting participants. For example, the COMPASS-CD trial is recruiting patients 18 years or older who have been diagnosed with Crohn’s disease in the past 5 years and have not had any disease-related complications. This study explores the real-world use of a tool called CDPATH that helps predict a patient’s risk of developing Crohn’s disease complications. The tool may help patients and HCPs engage in more productive discussions about their health.(5) Patients who choose to participate in a clinical trial can also help by sharing their story with others in their community.
By working together to improve diversity and inclusion in clinical trials, all stakeholders can help ensure that drug therapies are safe and effective for patients of diverse backgrounds. Doing so helps pave the way to reduced health inequities and improved patient outcomes.
This post is Sponsored by Takeda Pharmaceuticals
1. Clark LT, Watkins L, Piña IL, et al. Increasing diversity in clinical trials: overcoming critical barriers. Curr Probl Cardiol. 2019;44(5):148-172. doi:10.1016/j.cpcardiol.2018.11.002
2. Kim EJ, Kim T, Conigliaro J, Liebschutz JM, Paasche-Orlow MK, Hanchate AD. Racial and ethnic disparities in diagnosis of chronic medical conditions in the USA. J Gen Intern Med. 2018;33(7):1116-1123. doi:10.1007/s11606-018-4471-1
3. Quiñones AR, Botoseneanu A, Markwardt S. Racial/ethnic differences in multimorbidity development and chronic disease accumulation for middle-aged adults. PLoS One. 2019;14(6):e0218462. doi:10.1371/journal.pone.0218462
4. Barnes EL, Loftus EV, Kappelman MD. Effects of race and ethnicity on diagnosis and management of inflammatory bowel diseases. Gastroenterology. 2021;160(3):677-689. doi:10.1053/j.gastro.2020.08.064
5. Siegel CA, Horton H, Siegel LS, et al. A validated web-based tool to display individualized Crohn’s disease predicted outcomes based on clinical, serologic and genetic variables. Aliment pharmacol Ther. 2016;43(2):262-271.