American College of Clinical Pharmacology Advances Calls for Clinical Trial Diversity · BioBuzz

By Alex Keown
January 30, 2023

Despite gains in clinical trial diversity, more work needs to be done. That is the assessment of The American College of Clinical Pharmacology (ACCP), a Virginia-based professional association of pharmacologists.

In January, ACCP published a paper that highlights the need for increased diversity in drug development. The paper, dubbed “The Importance of Diversity and Inclusion in Drug Development and Clinical Trial Conduct” recommends increasing efforts to recruit more trial patients from varying racial backgrounds.

In the paper, the ACCP cited FDA data showing that among all New Drug and Biologics License applications between 2015 and 2019, participation of African Americans increased in 9 of the 13 recognized therapeutic areas of clinical research. Among those trials, African Americans represented at least 13% of the total study population, which ACCP said was proportionate to 2015 census data. However, Asians, Native Americans and Hispanic Americans were well below the census levels, the organization noted.

Most clinical trials were overwhelmingly Caucasian, making up about 78% of participants during that time period. Trials conducted in cardiovascular, pulmonology and rheumatology, and neurologic diseases were overwhelmingly Caucasian. White participants made up 90%, 84%, and 81% of the total enrolled populations, ACCP said.

“Underrepresentation remains a significant concern considering minority populations are more likely to be diagnosed with certain cancers and are more likely to die prematurely than White individuals,” ACCP said in its paper.

ACCP’s paper echoes other calls for broader diversity in clinical trials. Yusuf Henriques, Founder and Chief Executive Officer of IndyGeneUS AI initially launched the company to address the lack of minority inclusion in clinical trials.  A former FDA employee, Henriques saw clinical data packages for multiple pharmaceutical drug products up for approval. While the drugs were for different disease indications, he said they all lacked participation from a diverse patient population – even for drugs primarily aimed at minority patient populations.

To address this, IndyGeneUS AI uses state-of-the-art next-generation sequencing technology to generate a whole-genome sequence database. That database includes information from more than one million people from indigenous populations across the African diaspora. The diverse genetic data is expected to promote discovery of new biomarkers and drug targets and improve overall drug development.

In 2022, the FDA issued its guidance for improving diversity in clinical trials. The guidance urges drug developers to submit a diversity plan to the regulatory agency when filing an Investigational New Drug application.

The regulatory agency said enrollment in clinical trials should reflect the diversity of the U.S. population. The FDA also noted the existence of biological differences that can impact a medicine’s overall efficacy between racial groups. There are known response differences with certain asthma medications, as well as antidepressants and blood-pressure medications between different racial groups. Because of this, FDA Commissioner Robert M. Califf called increased diversity “fundamental to public health” when the guidance was released.

“Going forward, achieving greater diversity will be a key focus throughout the FDA to facilitate the development of better treatments and better ways to fight diseases that often disproportionately impact diverse communities,” Califf said in a statement.

ACCP recommends drug developers adapt the FDA strategy early during the Phase I portion of studies. This should be done to gain understanding of potential efficacy differences among the various trial participants based on race and ethnicity. Gaining an early understanding can influence late-stage studies and regulatory submissions, ACCP said.

“The ACCP strongly recommends that researchers and health care professionals across the care continuum be more active regarding the need for a greater diversity of participants in drug development and clinical trials,” the advocacy group said. “As health care professionals, regulators and researchers, we should strive to ensure our actions in the design, conduct, reporting and communication of clinical research reflect the diverse needs of our communities.”

While there are increased calls for clinical trial diversity from industry stakeholders, ACCP said that so far, “the actions taken to date have produced, at best, a partial response from our communities within the United States.

Another way to improve clinical trial participation among minority populations is to decentralize clinical trial sites. Last year, Dr. Harsha Rajasimha, the CEO and Founder of Jeeva and the Founder and Chairman of IndoUSrare, a rare disease-focused non-profit, explained that access to centralized clinical trial sites are limited. In a previous interview with BioBuzz, Rajasimha said 95% of people in the U.S. do not live near traditional trial sites.

“Access is very limited. Less than 3% of patients with cancer, for example, participate in clinical trials in the U.S. Even in oncology, which has the most research funding and largest patient population, enrollment is a big issue,” he added.

Rajasimha promotes decentralized trials. He said clinical trial sponsors can find patients via stable Internet portals. That gives them access to about 60% of the global population, he said.

“82% of Americans have internet access and can seek out information about clinical trials. Clinical trial sponsors can now find patients online and educate and engage them. Globally, 60% of people have access to a stable internet connection. Decentralized clinical trials offer a tremendous opportunity to significantly increase U.S. and global clinical trial participation, which would be a game changer for industry and patients,” Rajasimha said.