Lack of diversity in research is an issue that transcends therapy areas. It can lead to healthcare professionals having limited information on how new treatments work outside of the trial population.
Expanding clinical trial eligibility criteria could be at least part of the answer, believes Dr. Jeff Allen, Chief Executive Officer at Friends of Cancer Research (FoCR).
“Clinical research is conducted in a very homogeneous population,” he told Change Together. “It happens because researchers are trying to isolate the effects of the drug and reduce the other variables that could confirm those analyses. That’s understandable, but the downside is it provides limited information on the broader population that may ultimately use the drug in the long run.”
Barriers to clinical trial access
Because of this, FoCR has been working with the American Society of Clinical Oncology (ASCO) for several years to examine barriers to clinical trial access.
“What we found is that the eligibility criteria – used to identify the appropriate patient population – is often just recycled, rather than being decided on a trial-by-trial basis,” notes Jeff.
To counter this, FoCR/ASCO working groups have taken a “biological and scientific approach” that focuses on building consensus among patient advocates and the drug development, regulatory and funding communities about how to make trials readily available to more people.
The collaborative method has worked, Jeff says, explaining that its publications have so far led to five sets of U.S. Food and Drug Administration guidance documents, all aimed at increasing access to trials through expanded eligibility criteria.
Pushing the boundaries in HIV
One of the program’s first projects, for example, looked at why people with HIV had been unilaterally excluded from cancer trials, despite advances in treatment meaning they are now able to live longer, near-normal lives – “which, of course, makes them more susceptible to developing cancer.”
“If they’re not included in trials, it’s very difficult to understand if the medicine used to treat an underlying cancer would have any differential effects,” Jeff observes, adding that FoCR’s working groups have developed a set of specific recommendations to identify when it would be appropriate for these patients to be included in clinical trials and broaden access in this area.
“Our hope is that as we continue these initiatives to broaden clinical trials, they will become more representative of the people who actually use the drugs, leading to faster approval and greater access to clinical trials for those who are looking to participate as part of their care.”