Clinical trials in the United States have been plagued for years by two well-known problems: They don’t recruit enough people and they fail to reflect the diversity of our nation.
The good news is that solving the diversity problem can resolve both issues. Two birds, one stone.
Researchers whose job it is to fill clinical trials with participants have begun teaming up with tech companies to find modern solutions to this long-standing problem. This approach, however, is just a temporary patch to a problem that requires a longer, more sustained remedy.
First, the facts: 25% of cancer trials fail to enroll as many participants as they need, and 18% of trials close with fewer than half of the target number of participants after three or more years. As many as 86% of clinical trials do not reach recruitment targets within their specified time periods.
These failures have significant scientific and financial costs. Failing to recruit enough participants can jeopardize the results of a trial, which has been designed to answer a specific research question by recruiting a specific number of participants. It also raises ethical questions about the risks and benefits for patients who volunteer for trials that cannot be completed as intended.
Clinical trials can fail even when they manage to recruit the target number of participants. That’s because without a diverse set of participants, the knowledge they produce isn’t applicable to many Americans.
Last year, ProPublica examined the staggering lack of diversity in cancer drug clinical trials. The investigation revealed a stark and shocking underrepresentation of African Americans in clinical trials for cancer drugs, even when the type of cancer disproportionately affected this group.
And just last week, JAMA Oncology published a study demonstrating that reporting on race in cancer clinical trials is infrequently done, and blacks and Hispanics were consistently underrepresented in landmark trials that led to new cancer drugs being approved by the Food and Drug Administration. The study’s authors concluded that minorities need to be better represented in clinical trials to ensure the validity of results and reliable benefits to all.
This disparity is not confined to race alone. Most clinical trials lack participation from racial, ethnic, gender, and sexual minorities, as well as the elderly, people who live in rural areas, and individuals of varying socioeconomic backgrounds.
This lack of inclusion seriously hinders advances in biopharmaceutical research and development. And when a breakthrough does occur, it is difficult or impossible to tell if the discovery will work among populations not represented in the studies.
Technology companies are entering the fray and offering new solutions that aim to diversify clinical research and increase participation in it. These range from powerhouses such as Google’s Verily and Uber Health to smaller startups. The goals of these companies and their pharmaceutical partners are to reach patients in new ways and make it easier for them to enroll and participate in trials. Some companies have made it easier to navigate online processes for providing informed consent, an essential part of trial participation. Others use mobile apps to send personalized messages that help participants follow trial protocols and stick with them.
While this is a step in the right direction, technology alone cannot solve the recruitment challenges that clinical trials face. That’s because in many communities there continue to be deep skepticism and questioning about the value of clinical trials. Overcoming that skepticism requires improving trust, as well as gaining validation from respected community institutions and figures.
Biopharmaceutical companies and others running clinical studies must develop community engagement strategies that focus on building long-term, authentic relationships with the communities they seek to reach and the people who live within them. We know this from firsthand experience.
For the past three years, our company, HCM Strategists, has worked with the National Institutes of Health’s All of Us Research Program. The goal of this program is to enroll 1 million or more people from across the United States to volunteer data about themselves that will help uncover paths toward delivering precision medicine. The program has made progress, as described in a recent special report in the New England Journal of Medicine, but there is still much more work to be done.
Our focus has been on engagement — the art and science of building relationships and partnerships with potential participants — to ensure that the individuals the program enrolls reflect the diversity of our country. We have learned there is important work to be done with communities long before clinical trial recruitment begins.
First, individuals must be educated about the personal benefits — and risks — associated with participating in clinical research. Second, clinical trial sponsors must clearly explain how their research can benefit an entire community. Third, researchers need to address concerns about the historical abuses that have occurred in biomedical research within minority communities and what measures are being taken to prevent them from happening again.
Having this kind of information delivered by a trusted messenger is more likely to create a pathway toward trial participation among individuals and communities that have been historically underrepresented in research.
To put these findings into action, we have built and nurtured a national network of more than 1,000 community-based and health care provider organizations that serve as validators and trusted intermediaries to educate potential participants on the value of precision medicine and program participation in All of Us.
We work with everyone from local YMCAs to church leaders and professional societies that represent doctors and nurses. These are the community voices that individuals trust and who they listen to when it comes to the importance of participating in clinical research.
This approach is helping All of Us establish the trust, transparency, and value that is essential to ensuring participation by communities historically underrepresented in biomedical research. The question for other researchers running clinical trials is this: How are you thinking about pairing technology solutions with trusted community voices? If you aren’t, your efforts might be in vain.
We all have a stake in ensuring that clinical trials succeed and the knowledge they produce advances the health of all Americans. Technology has a role to play in helping realize this goal, but it cannot be deployed in isolation. Individuals skeptical about or unaware of biomedical research are not going to be motivated by a mobile app alone. Engagement at the individual and community level is absolutely essential and requires the involvement of real interpersonal relationships that build trust within populations.
These are the new rules of engagement in biomedical research.
Bobby Clark and Ronnie Tepp are principals with the health innovation team at HCM Strategists. Research reported in this publication was supported by the Office Of The Director of the National Institutes of Health under Award Number OT2OD023206. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health.
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