How We Cure Together: Research Towards Equitable Trial Recruitment
The Prostate Cancer Foundation (PCF) funds research that includes precision science and treatments. But access to treatments is also an important matter that we consider. Inequitable access to health care has been shown to be critical in determining patient outcomes and overall survival. In prostate cancer, disparity exists between Black and White men: Black men are more likely to be diagnosed with prostate cancer, with more aggressive forms, and at a later stage, when the disease is less likely to be curable. However, researchers have found that although Black men are far less likely to participate in clinical trials for prostate cancer, those that are enrolled have equal or even better outcomes vs White subjects. PCF-funded Young Investigator Dr. Hala Borno is developing a new digital tool to help streamline recruitment of patients into clinical trials – particularly for minority communities that are the most affected by lack of access to healthcare– and who have been consistently underrepresented in clinical trials.
The Recruitment Dilemma
Clinical trials can entail a complicated process that requires time, money, and most importantly, participants. How can trials best recruit participants that reflect the diverse population of cancer patients? Hala Borno, MD, a medical oncologist and assistant professor of medicine at the University of California, San Francisco (UCSF), is a PCF Young Investigator who focuses her research on disparities in cancer —that is, the differences among groups of people and their access to medical care that lead to inequity in cancer outcomes. Disparity in access to clinical trials means that we will not know how well, or how differently, cancer treatments work in certain groups of patients, and they may not receive optimal care. In a 2019 paper in the journal Pilot and Feasibility Studies, Dr. Borno and her team describe some of the key issues in clinical trial recruitment and their proposed intervention.
Participation remains a significant problem in clinical trials: Dr. Borno notes that more than 30% of clinical trial sites fail to recruit even a single participant, 50% of clinical trials fail to reach their enrollment goal, and fewer than 20% of clinical trials are completed on time. Racial and ethnic minority populations are underrepresented: Black and Hispanic patients make up less than 5% of all clinical trial populations, but comprise 12% and 16% of the US population, respectively.
What causes this difference in participation? Dr. Borno’s study notes that several factors play into it, including socioeconomic and communication barriers, as well as the logistics of current trial recruitment efforts. Digital interventions may be able to address some of these factors.
The Trial Library Pilot Study
Dr. Borno and her team are implementing a pilot study to evaluate a new digital clinical tool called Trial Library. (A pilot study is a small-scale test of how feasible an intervention is, before it is rolled out in a larger trial). The aim of the study is to use this online educational resource to promote discussion of clinical trials between patients and providers during an office visit, ideally leading to increased trial recruitment.
In the coming months, select prostate cancer patients will be given the option to use Trial Library during an office visit at the USCF Helen Diller Family Comprehensive Cancer Center. If they agree to be part of the study, they will be given an iPad with a version of Trial Library (currently in English; future work will include a Spanish version). In the waiting room, they will view a video and additional information about clinical trial participation and answer questions that may help “match” them with suitable trials. The patient will bring the iPad with the matching results into the exam room, prompting further discussion with their provider about types of clinical trials they may be eligible for. At the end of the visit, patients will receive a copy of the trial matching report.
Researchers will evaluate the experience by conducting a brief patient survey and interviewing patients and physicians. They look to measure participant satisfaction, the effect of Trial Library on discussion of and recruitment to clinical trials, and the impact on clinic wait time.
How might this intervention increase patient recruitment, especially those from underrepresented populations? Both the content and user testing of Trial Library were developed based on input from Black men with prostate cancer. It was designed to address the informational and technological needs of diverse patient groups, incorporating themes of transparency, honesty, and flexible access. Dr. Borno’s team aims to more fully understand the key factors in making research and treatment equitable for all cancer patients. The results of this preliminary study will inform the rollout of a larger trial of this digital health information tool, with the exciting potential to make clinical trials more accessible and inclusive.