In honor of Black History month, the FDA Oncology Center of Excellence (OCE) presented a virtual panel discussion in February about building trust in clinical trials within the community. The distinguished panel consisted of two medical oncologists (Dr. Lola Fashoyin-Aje and Dr. Hala Borno), a cancer center director (Dr. Robert Winn), a breast cancer survivor and current community ambassador (Bennette Hooker), a lawyer, cancer center board member, and breast cancer survivor (Rudene Haynes), a San Francisco-based health ministry leader and past clinical trial patient and coordinator (Wilma Batiste), and the current director of the FDA’s OCE (Dr. Richard Pazdur).
Though the panel highlighted Black History month, the conversation emphasized the importance of recognizing disparities in all communities. Dr. Winn pointed out that the overarching goal in cancer treatment should be “one team, one fight,” indicating that we are all in this together and that our approach should be to support one another to fight these diseases. Addressing inequities in one community is not meant to promote one group over another: rather, when we address barriers in one group, all groups benefit.
An essential theme of the discussion revolved around improving clinical trial participation among historically under-represented patient populations. Project Equity, a public health initiative by the OCE, focuses on ensuring that experimental treatments are studied in patients who have the disease. It is well known that certain races and ethnicities have a higher risk of developing certain cancers (i.e., Black men and prostate cancer), but if those races and ethnicities are not adequately represented in the clinical trials designed to treat those cancers, then the trial results will not paint a complete picture of the tolerability and efficacy of the treatments. In other words, if certain groups of patients do not participate in clinical trials, then the treatments cannot be tailored appropriately to those patients. Increasing diversity in trials is critical to ensuring that treatment interventions will be better able to help all groups of people.
Not only is expanding trial access a matter of obtaining data from the most pertinent groups of patients, but it also provides under-represented individuals access to potentially life-changing therapies. A long-standing myth in the Black community is the belief that participation in clinical trials means being a “guinea pig.” Likewise, many patients are under the impression that randomization to a non-experimental arm in a trial means that they are receiving a placebo drug. Overcoming these barriers will require clinicians and community ambassadors to educate patients that the non-experimental arm is the standard of care treatment that they would typically receive and not an inferior treatment.
An important aspect of designing inclusive trials is to carefully consider eligibility criteria that will not be too restrictive so as to limit under-represented patients who may want to participate. Traditionally, trials have often been designed to exclude patients with certain comorbidities, but in the real-world setting, many patients who may eventually receive the newly-approved treatments are likely to have multiple comorbidities that may or may not be represented in the trials. In such cases, clinicians are then faced with using medications in patients who are sicker than those in the trials, resulting in unpredictable toxicities. Scientists, clinicians, and trial designers should construct clinical trials in a way that studies the treatments in patients who are most likely to use those treatments once they are approved.
Practically speaking, this also means designing trials with logistics that are easy for the intended patients to adhere to. Trial designers should consider the types of patients they are trying to recruit, for example: people who have full-time jobs who cannot necessarily move out of town to undergo treatment or people who may have young children or other family responsibilities that hinder them from getting frequent labs or taking inconveniently-dosed medications. These are select examples mentioned throughout the program, with the underlying idea being that trial designs need to change to incorporate more diversity into research.
When it comes to recruiting for clinical trials, Dr. Borno discussed the significance of using technology to help overcome implicit bias. Early in the treatment of HER2-positive breast cancers, there were cases of Herceptin not being consistently offered to Black women because some providers thought that these patients might not be compliant with routine treatment every 3 weeks for up to 1 year. Additionally, studies revealed some of the following biases that oncologists harbor regarding patient recruitment: “Is the patient asking the right questions? Do they seem like they’re going to be adherent? Am I going to be able to get through the consent process quickly?”
Although these types of considerations may not be maliciously intended, they are preconceived notions or assumptions that inherently separate one group of people from another, resulting in inferior treatment and thereby inferior outcomes. Providers may not be aware of many biases that could be driving inequity. Technology can help steer clinicians away from defaulting to their implicit biases by presenting all opportunities to a patient based on their clinical status rather than other factors. At the University of California San Francisco, Dr. Borno’s team created a clinical trial matching tool, called the “Trial Library,” that rapidly determines which trials a patient may be eligible for, with the goal of increasing trial recruitment of consistently under-represented patients. The reality of the situation is that gaps in care will continue to exist if we default to our biases, so we should embrace the tools that broaden our practice and perspective.
Ultimately, education is at the core of closing gaps in care in clinical trials and healthcare overall. Education to providers will break biases and improve access to care by informing of the latest trials available. Clinicians are the gatekeepers of trials, and it is critical that clinicians are informed of all the possibilities for their patients. Better outcomes start with our clinicians and what they can offer to patients.
Education to patients, caregivers, and communities will dispel myths, increase awareness of health conditions, and empower individuals to take an active role in their care. Dr. Pazdur pointed out that the polarizing media portrayal of news has led to a lot of mistrust around medical information in recent years. One strategy to combat the mistrust in the community is to host conversations addressing misinformation, such as “Facts and Faith Friday,” which is a recurring talk hosted by Dr. Winn and the local Black church community. These talks started during the COVID-19 pandemic and continue to provide an opportunity for locals to hear accurate information from trusted sources. In San Francisco, Wilma Batiste is involved in organizing health symposiums and fairs where people can get free health screenings and talk to prior clinical trial participants. The more that patients are aware of clinical trials, the better they can advocate for themselves. To quote Dr. Pazdur on encouraging participation in clinical trials, “Do it for yourself and do it for others”. We all have a role in optimizing clinical trial diversification and closing the gaps in care.
