The History of Race in Randomized Controlled Trials

Laura E. Bothwell spoke today at the National Library of Medicine in recognition of African American History Month on “The History of Race in Randomized Controlled Trials: Ethical and Policy Considerations.”  Dr. Bothwell is a Postdoctoral Fellow at Harvard Medical School, Brigham and Women’s Hospital. Circulating Now interviewed her about her work.

Circulating Now: Tell us a little about yourself. Where are you from? What do you do? What is your typical workday like?

Laura Bothwell: I am from the wonderful small city of Duluth, MN. Having obtained a PhD in Sociomedical Sciences from Columbia University, I am currently a Postdoctoral Fellow in Health Policy, Law, and Ethics in the Program on Regulation, Therapeutics, and Law (PORTAL) in the Division of Pharmacoepidemiology and Pharmacoeconomics at Harvard Medical School/Brigham and Women’s Hospital. Here, I enjoy doing research on different topics related to pharmaceutical policy. Typical workdays currently involve exploring historical, ethical, and policy dimensions of pharmaceutical research and development.

CN: Can you tell us about the work you presented in your lecture, “The History of Race in Randomized Controlled Trials: Ethical and Policy Considerations”?

LB: This work is a part of my current book project on the history, ethics, and policy dimensions of randomized controlled trials (RCTs). The lecture focused on race in RCTs, describing when race has been measured in RCTs and why, exploring the impact on trial design of social sentiments and public policies related to race at different points in history. I discussed key historic events and subsequent regulations pertaining to protection and inclusion of racial minorities in clinical trials. I also provided a timeline of racial trends in research subject populations, comparing these populations to broader US populations to demonstrate the extent to which minority research subjects have been represented in relation to national population substrates. Finally, I explored perspectives on the ethical question of whether racial groups have been fairly represented in RCTs, and challenges for the future.

CN: Today’s lecture is part of NLM’s observance of African American History Month, can you expand on what motivated scientists and policy makers to address diversity in clinical trials?

LB: Racial diversity has always been present among participant populations in randomized controlled trials; however, this has not always occurred as a result of thoughtful attention to diversity. Historically, particularly in the 1950s and 1960s, scientists infrequently included information on the racial demographics of trial participants. When scientists enrolled minority populations in clinical trials, they tended to include those populations most readily and easily accessible as trial participants, rather than seeking a diverse set of patients who were representative of the broader population. This slowly began to change in the ensuing decades.

Part of this change may be attributed to the conscientiousness of scientists themselves. Additionally, minorities have increasingly held positions of power within the U.S. government and elected officials accountable to diverse electorates have successfully promoted biomedical research policies designed to fairly represent diverse populations. In general, the federal government has played a very significant role in motivating increased attentiveness to diversity in clinical trials. For example, the NIH Revitalization Act of 1993 required the appropriate inclusion of minorities in all NIH-funded research, and the FDA has recently taken a stronger role in demanding that research sponsored by pharmaceutical companies include diverse members of the population as trial subjects. Still, the work of making clinical trials fairly representative of broad populations is ongoing.

CN: You’ve made extensive use of the manuscript collections here at NLM, tell us what you’ve discovered here.

LB: The NLM History of Medicine Division (HMD) is an extremely valuable institution. Thanks to the knowledgeable staff, I have been able to locate pertinent documents and images related to the history of RCTs and race in clinical trials. Thomas Chalmers was a major thought leader in the history of RCTs, and his papers have provided a window into their historical expansion, including increased attention to the inclusion of minorities in clinical trials.

I have also relied on the NLM for digital access to historic trials that have helped me to depict historic demographic trends in clinical trials.

My favorite images for this project are of the Medical Committee for Civil Rights. These were bequeathed to the NLM HMD by the late Dr. Walter Lear, a socially minded archivist of material related to the history of public health movements. These pictures help to illustrate how concerns of racial equality penetrated some of the medical community long before policies for fair inclusion of minorities were established.

CN: What inspires you in your work and what do you hope readers will gain from it?

LB: It is exciting to carry out research that can expand our knowledge of the history and ethics of biomedical research systems so that we can better understand the effectiveness of various historic policies and identify areas that can be improved upon. I have always been passionate about reducing social inequalities, including racial inequalities. I view this project as a means of elucidating the challenges that society and biomedical researchers have faced with regard to ensuring the fair representation of racial minorities in clinical trials and telling the stories of how these challenges have been addressed effectively or ineffectively. This history can help to clarify and inform contemporary ethical and policy approaches as we work to ensure that people of all backgrounds are treated fairly by biomedical research systems.

Laura E. Bothwell’s presentation was part of our ongoing history of medicine lecture series, which promotes awareness and use of the National Library of Medicine and other historical collections for research, education, and public service in biomedicine, the social sciences, and the humanities.