Celebrating AAPI Heritage Month: Boosting Clinical Trial Participation

Eunjoo Pacifici, PharmD, PhD, Chair of the Department of Regulatory and Quality Sciences; Associate Professor of Regulatory and Quality Sciences, USC School of Pharmacy

Eunjoo Pacifici, PharmD, PhD, describes her work educating students to be the next generation of clinical research professionals.

Asian American and Pacific Islander (AAPI) Heritage Month in May pays tribute to the many contributions of these populations to the history and culture of the United States. Today, Asian Americans are well-represented in highly skilled jobs. For example, while making up only 6.6% of the U.S. workforce, they account for 43% of medical scientists. More than 1 in 5 (or 195,000) physicians and surgeons are AAPI, and 1 in 7 (or 132,000) are AAPI immigrants.

In contrast, Asian Americans are inadequately represented in clinical trials. For example, despite comprising 6% of the US population, Asian Americans accounted for just 2% of US clinical trial participants in studies between 2015 and 2019, based on 231 U.S. Food and Drug Administration (FDA) data snapshots.

In this first blog in a series to mark AAPI Heritage Month, Eunjoo Pacifici, PharmD, PhD, describes her experiences and suggests ways to improve trial diversity. Pacfici is Chair of the Department of Regulatory and Quality Sciences and Associate Professor of Regulatory and Quality Sciences at USC School of Pharmacy. In addition to pharmacy experience, Pacifici has worked in clinical research at Amgen, focusing on the Asia-Pacific and Latin American regions.

“My role at USC focuses on educating students to become the next generation of professionals in the regulated biomedical industry,” says Pacifici. “Asian Americans represent a significant segment of our student body, so I’m not worried about this population from a workforce point of view – including the clinical research workforce. However, it’s well known that we need to increase the diversity of clinical trials – including for AAPI populations – so that safety and efficacy profiles of new products adequately reflect Asian American patient responses.”

“Increasing the representation of AAPI populations in trials would also fulfil the FDA mandate to improve clinical trial diversity,” states Pacifici. “At the same time, we should keep in mind that Asian populations are highly heterogeneous, originating from many countries – including South Korea, China, India, Vietnam, Taiwan, and the Philippines – each with widely differing cultures and languages. Across ethnicities, there may be cultural and language barriers to taking part in clinical trials. AAPI populations may not be aware of the benefits of clinical research, including gaining access to cutting-edge treatments that might not otherwise be available.”

Pacifici notes that sponsors should consider targeted engagement with community leaders at the earliest possible stage to increase awareness of clinical trials and ultimately to support recruitment. “This grass-roots outreach should include foundational information about clinical trials as well as information on how engagement with the clinical research process will benefit all members of the participants’ community.”

“USC is one of the hubs for the National Institutes of Health (NIH) Clinical and Translational Science Awards (CTSA) program,” notes Pacifici. “Community engagement is a major part of this initiative, including disseminating information about clinical trials to lower barrier to participation.”

“Funding innovative approaches to community engagement that are specific to Asian American communities would be helpful. There should also be a separate focus on Pacific Islanders, helping address the information gap about this population. National, regional and local strategies are needed, taking account of the differing distributions of various AAPI populations across the US. Care should be taken to include hard-to-reach populations as well as accessible urban ones.”

“By improving education and increasing awareness early on, we can position members of the AAPI community to be more receptive to participating in clinical trials,” concludes Pacifici. “Education about the high priority given to patient safety, as well as the ethical guidelines that are in place throughout the trial process, can help to reduce fear, which may be a major barrier to participation. These educational efforts hold promise to improve trial diversity as well as improving access to clinical research as a care option for these populations.”

Author: Jill Dawson