Pharma trade group issues guidelines for improving diversity of clinical trial participants

PhRMA issues guidelines for improving clinical trial diversity - STAT PhRMA released guidelines on Tuesday to enhance racial and ethnic diversity among participants in clinical trials. Nicholas St. Fleur STAT

The pharmaceutical industry’s largest lobbying organization released guidelines on Tuesday to enhance racial and ethnic diversity among participants in clinical trials run by its member drug makers. The principles address a problem that has long hampered the development of new medicines and vaccines, including the studies of potential Covid-19 shots.

The group, PhRMA, noted that the guidelines are voluntary; they do not take effect until April 2021.

It outlined four main areas of focus to decrease health disparities and address systemic racism in medical research. The first is to build trust through outreach to Black and brown communities, which have been historically underrepresented in clinical trials, and to acknowledge past wrongdoings that have fueled distrust, such as the Tuskegee syphilis study and the exploitation of Henrietta Lacks, an African American woman who in 1951 had her cancer cells taken and used for research without her permission.

PhRMA also set goals for companies to reduce barriers to accessing clinical trials in these communities; monitor how treatments or preventive measures work in diverse populations after the clinical trials are over and the products have been approved; and to be transparent about their commitments and efforts to increase diversity and inclusion in clinical trials.

It’s really just the first step. We envision building on these principles, which are aspirational, and doing significant outreach in the communities of color and to ensure that we’re holding ourselves accountable,”  said Stephen Ubl, the president and CEO of PhRMA, during a sponsored segment at the 2020 STAT Summit on Tuesday. “We’ve got to close the gap between the patient populations impacted by disease and the composition of these clinical trials,” he said. ...