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Increasing Diversity in Clinical Trials: A Q&A With Jennifer Miller, PhD

February 27, 2023

Jennifer Miller, PhD, associate professor of medicine (general medicine), researches equity, governance, and ethics in drug, vaccine and medical device research, development, and delivery, as well as in health care data sharing. She also specializes in developing and using metrics to enhance accountability and social responsibility in biomedical innovation.

Q: Tell us more about your current efforts to promote diversity in medical research.

A: We've published a series of studies evaluating who has access to and enrolls in clinical trials, and we found that we tend to test new medicines and vaccines on patients who are healthier, younger, and more likely to identify as white and male than real-world patients with the conditions or diseases that a trial is targeting.

One of the studies that's getting a lot of media attention looked at the fair inclusion of women, older adults, and patients identifying as racial and ethnic minorities in pivotal trials supporting novel cancer drugs approved by the FDA between 2012 and 2017. Only about half of companies fairly included women, 20 percent fairly included older adults, and four percent fairly included racial and ethnic minority-identifying patients. Interestingly, there were some companies that consistently performed well.

We received a new grant from the FDA to study those high performing companies over a 10-year period to identify factors enabling their high performance that can be implemented by the broader sector to produce similar positive results. Working with the Good Pharma Scorecard, an index that ranks pharmaceutical companies annually based on a series of bioethical measures, we helped add new clinical trial diversity measures. With equity-related measures added into the scorecard, we can track progress on these equity goals and incentivize change quickly. We've had a lot of success with the Good Pharma Scorecard in the past. In 2019, for example, we introduced new measures for data sharing, and 50 percent of large companies improved their procedures within 30 days of getting a low Good Pharma Scorecard result. It can be an effective reform strategy.

Q: Why is it important to have broad representation in these clinical trials?

A: We need fair access to the benefits of clinical research. One of the benefits of clinical research is the medical evidence it generates. When clinically distinct groups are not represented in the medical evidence, justice and public health concerns are raised. Is the safety and efficacy information generalizable to underrepresented groups? Who has opportunities to participate in research?

Q: How did you first become interested in this work?

A: There are many determinants of health, including access to medicines and vaccines. When we think about access to medicines and vaccines, we have to think about the role of the pharmaceutical industry, as they sponsor 90 percent of the clinical trials that support FDA approval of these products. It's important for that industry to be patient-centered and socially responsible.

I also think being born and raised in Ecuador has influenced my interest in addressing health disparities within the U.S. and among low- and middle-income countries, including my current efforts around fair access to the benefits of biomedical research.

Q: What are the biggest challenges of your work. The biggest rewards?

A: Some of the challenges when I started this 15 years ago were establishing credibility for the Good Pharma Scorecard, and persuading pharmaceutical executives to focus on their bioethics and social responsibility. If pharmaceutical companies didn't pay attention to the index, it wouldn't work as an effective reform tool.

We’ve overcome that hurdle. Large pharma companies pay attention to their scores and use the metrics we develop in their own internal policies and procedures. When they don't score well, they're interested in figuring out why. Investors and patient groups also use the scorecard. Now, it's an established mechanism for tracking performance and catalyzing change. We are working hard to expand its scope year after year.

Q: What kind of impact do you hope to have?

A: The aim is to advance health for all, with current work focused on the role of the pharmaceutical, biotechnology, and medical device sectors. Yale has a pioneering history of developing transformational quality, outcome, and performance measures, including for hospitals, that have measurably improved patient care and countries’ environmental and climate change performance. I think we can and are doing something similar for pharma and biotech on bioethics, social responsibility, equity, and justice issues that are critical to get right for patients and for public and global health.

Submitted by Serena Crawford on February 28, 2023