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

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.

He brought up the example of type 2 diabetes, where Black, Latino, and Asian populations make up about 35% of patients with the disease, yet only four drugs have been studied on these groups. Those four make up less than 20% of the medications that are available for treating type 2 diabetes.

Ubl said the guidelines are part of a multiyear effort that he envisions will include a partnership between the government and the private sector to invest in infrastructure at the local level in Black and brown communities to enhance clinical trial enrollment of these populations.

Jonathan Jackson, director of the Community Access, Recruitment, and Engagement Research Center at Massachusetts General Hospital and Harvard Medical School, said he was surprised at how thorough the PhRMA guidelines were. But he questioned how effective they would be because they lack a mechanism of accountability and enforcement, and insight into who will pay for implementing the infrastructure to achieve these guidelines.

“It’s a step in the right direction,” said Jackson. “Is it going to translate into any kind of meaningful difference? Probably not. But hopefully, it will get people thinking about it, and maybe down the road, we’ll get somewhere.”

The guidelines come on the heels of the Food and Drug Administration’s release last week of the final version of its guidance on enhancing diversity in clinical trials. The PhRMA guidelines focus mostly on racial and ethnic diversity, while the FDA also addresses sex and age, as well as non-demographic characteristics such as disability, organ dysfunction, and comorbidities.

While PhRMA did not say how members would be held accountable for following the voluntary guidelines, Richard Moscicki, the group’s chief medical officer, said he was confident member companies would hold to these commitments, which he said were passed unanimously by its board members.

“Covid has particularly unmasked how those inequities have affected health care, and our industry feels that we must and will do something about this.” He said that addressing clinical trial diversity was one way they could. “We believe that this is an important path to improving the racial inequities in health care as well.”

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