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Barriers and hope for diversity when it comes to clinical trials

Prateek Mendiratta, MD
Physician
October 30, 2017
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The diversity of patients seen in any oncologist’s clinic is a microcosm of what makes America so unique. From one room to the next, I am amazed by the various ethnicities, economic backgrounds, and religious faiths that I encounter. Each of these patients forms a composite of beliefs regarding their cancer; just as every tumor we treat is different, so is every patient. This diversity is what makes generalizations in cancer care so difficult. Inevitably, I am asked by my patients, “So what will the treatment do for my cancer?” I usually answer the question based on clinical trial data and my “real-world” experiences with the treatment. Yet, do the clinical trials reflect my patients? Sadly, the answer remains no. We as oncologists are tasked to do better, to design clinical trials that reflect our patient mix, and to offer hope to all of our patients rather than a select few.

This disparity is clearly evident when it comes to clinical trials not representing our population. It is a clear fact that minorities, women, the elderly, those with poor socioeconomic backgrounds, and those with less education have less access to and enrollment on clinical trials. When those patients ask me what their likely outcomes are, am I truly giving them relevant data when patients like them were not included in the large phase III trial comparing the latest wonder drug versus placebo? Can I honestly share with them the expected response rate, toxicities, and overall survival when there may be differences in the way certain groups respond to certain drugs? I wrestle with this in clinic very often.

Part of the problem is in how our trials are designed. The exclusion criteria are the de facto gatekeeper. I often wonder, rather than focusing on exclusion, what could we oncologists do to try to include more patients in trials? I am inspired by the charge by ASCO and Friends of Cancer Research “to promote a culture of inclusion” to clinical trial eligibility by focusing on key populations that were routinely excluded in clinical trials.

Lack of representation may also lie in the stigma and negative connotations when it comes to clinical trials. The medical community has a checkered past in targeting, exploiting, and harming specific minorities and those with poor socioeconomic backgrounds. These memories cannot ever be forgotten; the travesty must always remind us that these abuses can never be repeated. We owe it our patients to educate them that there are clear safeguards and multiple regulatory guidelines to protect people enrolled on trials. Take the time in clinic to face this issue head-on: Respect your patient’s feelings about trials participation, yet be ready to educate them how trials being conducted in the modern era focus on hoping to improve patient outcomes.

This lack of diversity is especially concerning for those patients who are desperately seeking a bone marrow transplant. On every given day in every city, there seems to be “volunteer drives” held to raise awareness and try to get people out to swab their cheek for the Bone Marrow Registry. Finding a potential match can make the difference between life and death. Minorities are underrepresented in the national registry, leading to the lack of available matched transplants. Every time you renew your driver’s license, you are asked if you want to be an organ donor, yet not a bone marrow donor (which is a far more simple donation, I may add).

Are oncologists and advocates educating these communities? I am sure part of the problem lies in the lack of awareness about the critical need for donors and illustrating the easy steps involved in donating. I see academic centers and other centers with strong success in clinical trial enrollment using multiple platforms (including social media, community engagement, and education of community doctors) to educate those underrepresented populations. Patient advocate groups can clearly use these same platforms to personalize the clinical trial experience to reach a broader audience. Mistrust of the medical community also plays a huge factor here; it is something we need to face, and earn the trust of our communities by honest dialogue.

Not every patient needs or wants to be treated on a clinical trial. Finding the right treatment for each individual patient truly is an art that requires years of experience and training. Yet I wonder, in this era of precision medicine, are we not failing a majority of our patients by not including them in our clinical trials? As oncologists, we have taken on the responsibility to improve the outcomes of all our patients, and I have hope that future changes will allow us to reach those goals. I have hope that we will continue to advance the field with breakthroughs led in part by the brave patients and families who chose to enroll in clinical trials.

Prateek Mendiratta is an oncologist.

Image credit: Shutterstock.com

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