Pfizer publishes clinical trial diversity data

Designing for Diversity

How important is it to assure diversity, percentage and proportion? Some diseases impact different communities at different rates and with differing severity. In these cases a shortage of clinical trial subjects representing the most affected groups is scientifically and clinically meaningful.

Pfizer has become a leader in the pharmaceutical industry by considering this issue and publishing a report delineating racial participation in its clinical trials for the last 10 years, according to Nicole DeFeudis, associate editor of Endpoints.

The pandemic turned a harsh spotlight on a historic lack of diversity in the biopharma industry. Now, in an effort to foster transparency, Pfizer has published diversity data from its clinical trials going back 10 years, showing that there is much work to be done.

Black or African American people, who account for 13.4 percent of the US population, were shown to make up 14.3 percent of 212 clinical trials for which Pfizer collected data on race. While this may seem reasonable, it ignores the higher rates at which African Americans suffer from some diseases.

For example, black people die from all forms of cancer more frequently than any other race, but only 15.8 percent of subjects in Pfizer’s oncology-related drug studies. Black people are also 30 percent more likely than others to die from coronary diseases but were again underrepresented in the relevant drug trials. Finally, they are three times more likely to contract the coronavirus and twice as likely to die of it but were underrepresented in vaccine trials.

Pfizer’s data is worse for Asian Americans, who only made up 3.1 percent of clinical trials compared to 5.9 percent of the US population. Hispanic or Latinx participants represented 15.9 percent of clinical trials, versus 18.5 percent of the population. In total, 16 percent of Pfizer’s trials surpassed census levels for Asian participants, compared to 14.2 percent for Native Hawaiian or Pacific Islanders, and just 8.5 percent for American Indian or Alaska Natives.

Minority groups have historically been left out of clinical trials. Of the 53 drugs approved this past year, black patients represented about 8 percent of participants in the trials regulators based their decisions on (and for which data on race were collected).

According to Peter Pitts, president and co-founder of the Center for Medicine in the Public Interest and former FDA associate commissioner for external relations, “It certainly is in no way time for us to pat ourselves on the back and say, you know, we’re doing a great job when it comes to enrolling people of color in clinical trials. Making trials more diverse is going to require harder work by CROs. It’s going to be more expensive … We’re going to have to actually act on the data that we get.”

Marie-Pierre Hellio Le Graverand, Pfizer’s senior VP and head of clinical development and operations, said the analysis, which she co-authored, offers a much-needed baseline for improvement. “In order to improve … we have to know where we are starting,” she said. When asked why Pfizer used census data in its comparison, Hellio Le Graverand said there are gaps in available epidemiology data. As a result, Pfizer is building an epidemiology library to guide its future decisions on how to recruit for clinical trials.

Pfizer is taking other steps to improve its clinical trial diversity, including training those who manage trial operations, covering transportation costs and leveraging digital tools to reduce the burden on participants, and seeking out partners to place trial sites in diverse communities and raise awareness for trials, according to Hellio Le Graverand. To track its progress, Pfizer will publish another analysis of its diversity data in the next two to five years. According to Pitts, “Right now, diversity data is simply an afterthought on fulfilling recruitment requirements. We’ve got to do a better job doing it on purpose.”