Columbia University and Pfizer Inc. have established the Columbia-Pfizer Clinical Trials Diversity Initiative, which aims to reduce health disparities by increasing the number of minorities in clinical trials and making clinical researchers more diverse.
In the United States, 12% of the population is Black and 18% is Hispanic or Latino but in 2020, only 8% were Black and 11% were Hispanic among the 32 000 patients who participated in clinical trials that led to FDA approval of new drugs. For example, a review of clinical trials between 1999 and 2015 for cystic fibrosis only had a representation of 2.0% for Latinos, 1.0% for Black individuals, and 0.1% for Asians.
“People of different ethnicities can have different responses to the same medicine or treatment, so a lack of diversity among clinical trial participants means doctors cannot know if the treatment will be effective in all the patients they treat,” said Anil K Rustgi, MD, Interim Executive Vice President and Dean of the Faculties of Health Sciences and Medicine at Columbia University and director of the Herbert Irving Comprehensive Cancer Center. “Increasing diversity in trials will improve the treatment of patients from underrepresented groups and is a moral imperative as well as a fundamental medical issue.”
Rod MacKenzie, PhD, Executive Vice President and Chief Development Officer at Pfizer, said, “Diversity of representation in clinical trials is a matter of equity, which is a core Pfizer value. We are deeply committed to ensuring our clinical trials reflect the diversity of the communities like New York in which they are conducted. We look forward to working with Columbia University both to offer any willing individual, regardless of background, the opportunity to participate in and contribute to clinical research, and to expand the roster of diverse clinical researchers who are helping us conduct studies.”
Pfizer will provide a three-year, $10 million grant to Columbia to help establish and expand the Initiative, which will improve the diversity of participants in clinical trials by looking at the barriers that prevent participation by marginalised individuals. The Initiative will expand Columbia’s Community Health Workers Program network to connect with underserved populations and create culturally sensitive engagement tools. The efforts will include researching new ways to increase the accessibility of clinical trials through telemedicine, wearable technology, and home visits.
The Initiative also aims to improve diversity among clinical research faculty and staff. Columbia will help build an additional pipeline of diverse clinical investigators through a new National Diversity Clinical Trials Leadership Program to increase the number of faculty and staff from underrepresented groups as well.
“A diverse research staff not only helps to improve trust in clinical trials among participants from underserved groups but improves the entire clinical trial enterprise by bringing different questions, experience, and perspective to the table,” Dr Rustgi said.