Eligibility and diversity in clinical trials: Shifting the needle

Nov 20, 2019
Eligibility and diversity in clinical trials: Shifting the needle

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.”


Eligibility and diversity in clinical trials: Shifting the needle

Jeff Allen is President and CEO of Friends of Cancer Research (Friends). Friends is an advocacy organization based in Washington, DC that drives collaboration among partners from every healthcare sector to power advances in science, policy, and regulation that speed life-saving treatments to patients. For more than two decades, Friends has been instrumental in the creation and implementation of policies ensuring patients receive the best treatments in the fastest and safest way possible.
For over 10 years, Jeff has been a driving force in the growth and success of the organization. Under his leadership, Friends has evolved into a nimble, forward-thinking policy, public affairs, and research organization. As President and CEO, he leads the strategic development and implementation of Friends’ scientific, policy, research, and legislative initiatives, as well as overseeing Board governance and organizational operations.
As a thought leader on many issues related to the Food and Drug Administration, regulatory strategy, and healthcare policy, he is regularly published in prestigious medical journals and policy publications. In addition to participating in major scientific and policy symposiums around the country each year, Jeff has had the honor to be called to testify before Congress on multiple occasions and regularly contributes his expertise to the legislative process. Recent Friends initiatives include the establishment of the Breakthrough Therapies designation and the development of the Lung Cancer Master Protocol (Lung-MAP), a unique partnership that will accelerate and optimize clinical trial conduct for new drugs.
Jeff has the privilege to also serve on a variety of influential committees, boards, and advisory councils including the Alliance for a Stronger FDA (Board Member, Past President), the Medical Evidence Development Consortium (MED-C; Board Chair), Lung-MAP Senior Leadership Team Member, and a participant on working groups convened by the National Academies of Medicine and President’s Council of Advisors on Science and Technology (PCAST).
Prior to joining Friends, Jeff was an endocrinology researcher at the National Institutes of Health. His background in cancer research focused upon molecular changes associated with cancer formation as well as treatments to prevent cancer progression. Jeff received his Ph.D. in cell and molecular biology from Georgetown University, and holds a Bachelor’s of Science in Biology from Bowling Green State University.

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