Clinical trials struggle to include diverse patient groups that enrich and refine their results, but new tools are turning the tide.
Clinical trials are critical to the development of medicines that can improve and extend lives. But the medical research world is waking up to a problem: A lack of diversity in the patient populations. In 2016, for example, out of 31,468 participants in clinical trials, 76 percent were white.
This isn’t just an issue of representation. “Differences between people can often lead to variable or different responses to the same medication,” explains Kate Owen, senior vice president of global clinical operations at Bristol-Myers Squibb. “The gender, age, race, and ethnic origin of a patient may play a role in how treatment may work or even how safe it may be.”
Thomas Farrington, a prostate cancer survivor, author, and founder of the Prostate Health Education Network (PHEN), knows from personal experience the importance of diversity in clinical trials. “Black men are 60 percent more likely to be diagnosed with prostate cancer and suffer a 130-150 percent higher mortality rate,” he says. “We have an ongoing clinical trial initiative to educate about participation in clinical trials and the benefits of clinical trials because diversity in clinical trials is absolutely an ongoing challenge.”
This matters because researchers need data. “The participation rate for African American men for prostate cancer is at levels that are not statistically significant. [This] presents a problem when you want to look at some population analysis — for instance, how African American men may fare with a certain treatment relative to the population as a whole, because the participation is so low, it’s hard to rely upon that data. So there is a need for a big push to increase diversity in clinical trials.”
Online tools are seen as a good way to make that push. “We’ve created a prostate cancer-specific search tool on our website we call Find Your Trial (FYT),” says Farrington. “With one click you can identify trials that may be appropriate for you.”
Bristol-Myers Squibb is also using the Internet to drive up trial participation in diverse groups across many different conditions and diseases. “We have over 150 studies being conducted across the globe,” says Owen, “and we’ve developed a website called Study Connect as a starting point. Patients have the opportunity to complete a brief pre-screening questionnaire which can help match them to an active BMS clinical trial. We are also proud that Study Connect will not only match patients to BMS trials, but non-BMS available trials as well.”
Another way to increase diversity is through educating people on the benefits of participating in clinical trials. “Through our clinical trials, we are working to match the right clinical trial with the right patient at the right time,” says Owen. “We are exploring a variety of innovative tactics that bring those trials to the communities where the patients are found, including focusing on the geographic locations where the patients with the diseases we are studying are living. We also work with physicians, disease-specific organizations, and community groups to bring awareness, accessibility, and the voice of the patient to clinical trials.”
And clinical trials aren’t reserved for the terminally ill. “A lot of patients don’t know that clinical trials are available along a journey,” notes Farrington, “for example, a prostate cancer journey. There are clinical trials available for the newly diagnosed and for the last stage of treatment — through the whole continuum of the disease journey.”
The push for diversity is receiving whole-hearted support from large pharmaceutical companies that run clinical trials like Bristol-Myers Squibb. “BMS is committed to ensuring that our clinical trials reflect the patients most affected by the conditions we are researching,” Owen says proudly. For Owen, the bottom line is simple. “Broader representation leads to better science,” she says, “and better science leads to safer and more appropriate medical practice and care for all of us.”
Jeff Somers, [email protected]