The under-representation of certain demographic groups in clinical trials of drug therapies has long been known to exacerbate health disparities. Drug companies have endeavored for decades to improve demographic representation in their research, but the impact of these efforts has been difficult to ascertain, according to a new research paper.
The paper, published January 5 by Michelle Mello (BA ‘93), Stanford Law School professor and professor of health policy at the Stanford University School of Medicine, and collaborators at the Yale School of Medicine introduces the fair inclusion score, the first-ever method to systematically rate drug companies on their inclusion of women, older adults, and racial and ethnic minoritized patients in clinical research relating to cancer drugs. The novel rating system is outlined in the researchers’ paper, “Metrics, Baseline Scores, and a Tool to Improve Sponsor Performance on Clinical Trial Diversity: Retrospective Cross Sectional Study,” published in BMJ Medicine.
The study is the latest work by researchers affiliated with the nonprofit organization, Bioethics International, to expand its Good Pharma Scorecard, which ranks companies on their bioethics and social responsibility performance and governance.
"Representation in clinical trials is important because not all therapies perform the same in all groups of patients,” Mello said. “Patients and physicians depend on clinical trial evidence to make the best decisions about cancer care. When cancer trials haven't been inclusive, it's harder for a doctor to look a patient in the eye and say with confidence, ‘I believe this is the best course of treatment for you.’”
The fair inclusion score was informed by transparency and inclusivity data collected from 64 clinical trials of novel drugs and biologics approved by the U.S. Food and Drug Administration for cancer-related conditions between 2012 and 2017.
“Policy efforts to improve trial diversity span decades, with little impact,” the researchers noted in their paper. These disparities are especially pronounced in cancer drug trials. While the researchers acknowledge the efforts of drug companies to improve diversity in clinical trials, they conclude that “additional strategies are needed to make an impact on diversity in trials. Studies have shown that publicly rating organizations can be an effective quality improvement strategy.”
Monica Schreiber is the Assistant Director of Communications at the Stanford Law School.