Bioethics International Publishes New Index to Score Pharma Companies on Clinical Trial Diversity in BMJ Medicine

• The Fair Inclusion Score, Published by Bioethics International in Collaboration with Researchers from Yale and Stanford, Is the First Benchmark of Clinical Trial Diversity, Equity and Inclusivity, Rating Pharmaceutical Companies on the Fair Inclusion of Women, Older Adults, and Racial and Ethnic Minorities

NEW YORK, Jan. 5, 2023 /PRNewswire/ -- Bioethics International today announced the publication of its fair inclusion score, a method to measure and rank pharmaceutical companies on their fair inclusion of women, older adults, and racial and ethnic minoritized patients in clinical research, in BMJ Medicine. Bioethics International is a not-for-profit organization dedicated to raising the bar on ethics, equity, trustworthiness, and patient-centricity in the biopharmaceutical industry.

Demographic representation in clinical research is important for equitably assessing the safety and efficacy of novel therapeutics for the patients who will use them. Some groups, however, are consistently underrepresented in research, exacerbating disparities in access to research and quality medical care.

To measure inclusivity, researchers in this study developed the fair inclusion score, informed by transparency and inclusivity data collected from 64 pivotal clinical trials of novel drugs and biologics approved by the U.S. Food and Drug Administration (FDA) for oncologic conditions between 2012 and 2017.

The fair inclusion score considers transparency of reporting and the representation of three demographic groups that are often underrepresented in clinical trials in comparison to the disease-specific population: sex (percentage of participants that were female), age (percentage of adults older than 64) and race/ethnicity (percentage of participants identifying as Black, Asian and/or Latinx). The transparency and representation scores are combined into one total fair inclusion score.

One of the 25 ranked companies – United Therapeutics – achieved a fair inclusion score of 100, while seven companies – Puma Biotechnology, Sanofi, Takeda Pharmaceutical Company, Amgen, Bristol-Myers Squibb, Eli Lilly and Company, and Merck KGaA. – received the gold rating, scoring in the top quartile on clinical trial diversity performance.

"The lack of diversity in clinical research is a social justice and a public health problem. Clinical trials supporting FDA approval of new medicines are often tested on patients who are younger, healthier and more likely to identify as white and male than the patients who use new therapies. Despite decades-long policy efforts to improve the inclusion of women, older adults and racial and ethnic minorities, disparities persist," said Jennifer E. Miller, Ph.D., founder of Bioethics International, an Associate Professor in Yale School of Medicine, and senior author of the study. "The purpose of the fair inclusion score is to provide companies and industry partners with a metric to assess how well companies are doing improving clinical trial diversity. Some companies are doing well, and we want to highlight that and learn from them, while pushing the industry to do better. We hope this, along with our Good Pharma Scorecard, continues to drive positive changes to industry practices."

Samit Hirawat, M.D., Executive Vice President, Chief Medical Officer, Global Drug Development, Bristol Myers Squibb, said, "At Bristol Myers Squibb, we want everyone to have a fair and just opportunity to achieve optimal health outcomes, and our clinical trial diversity strategies go beyond patient recruitment by including efforts to create an ecosystem around the trials that is reflective of the diverse populations being served. We are proud of the progress we've made and this recognition from Bioethics International, while recognizing how much more must be done to effect sustainable change."

Michelle Mello, J.D., Ph.D., Professor of Law at Stanford Law School and Professor of Health Policy in the Department of Health Policy at Stanford University School of Medicine, and co-author on the paper said, "Representation in clinical trials is important because not all therapies perform the same in all groups of patients. 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.'"

Alan Auerbach, Chief Executive Officer and President of Puma Biotechnology, said, "We are honored to be recognized as one of the top performers in the oncology space for inclusivity in clinical trials. At Puma, we believe in the importance of including a diverse patient population in clinical trials, as improved representation leads to a better understanding of a drug's clinical profile. We commend the work Bioethics International is doing to provide this metric to help us and others in the industry improve how we recruit and retain underrepresented populations in clinical trials."

Kimberly Sabelko, Ph.D., Vice President of Scientific Strategy and Programs at Susan G. Komen, which provided funding for this research, stated, "Susan G. Komen's mission to save all lives from breast cancer requires treatments to be effective in all patients, regardless of who they are or where they live. To achieve that, clinical trials must include patients representative of the people likely to use a medicine once it's FDA-approved.  Too many clinical trials don't yet meet that mark.  The fair inclusion score provides a tool to assess the diversity of clinical research and track progress over time. We hope it will help drive pharma companies to increase transparency about and the diversity of enrollment in cancer clinical trials, and really transform them from exclusive to inclusive opportunities to advance science and improve healthcare for everyone."

The full rankings and methodology are available in the publication entitled "Clinical Trial Diversity: Metrics, baseline scores, and a tool to improve sponsor performance" in BMJ Medicine.

About Bioethics International
Bioethics International's mission is to help transform the way we understand, engage, and operationalize bioethics in the healthcare innovation sector, to improve its trustworthiness and patient-centricity and advance health. Currently, Bioethics International focuses on the social responsibility and governance of how medicines and vaccines are researched, developed, marketed and made accessible to patients around the world. For more information, please visit www.bioethicsinternational.org.

Funding Disclosures
This study was supported by a grant from the Susan G. Komen Foundation.

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SOURCE Bioethics International