Abbott Builds Upon Diversity in Clinical Trials Initiative by Partnering with Women as One

The partnership between Abbott and non-profit Women as One will train female and underrepresented physicians to help improve diversity in clinical trials.

Research from recent years shows that representation of women and ethnic minorities, especially African Americans, still needs to be improved in most drug development programs approved by the US Food and Drug Administration’s (FDA) Center for Drug Evaluation and Research (CDER). In a study that analyzed the demographics of clinical trial participants of the 102 new drugs approved between 2013 to 2015 by the FDA’s CDER, only 40.4 percent of the participants were women and 6.4 percent were Black/African American.

For these reasons, the FDA released a new draft guidance for industry in April about improving racial and ethnic diversity in clinical trials.

Regarding the participation of women in cardiovascular clinical trials, a study showed that from 2010 to 2017, a good representation of women was found in trials for hypertension and pulmonary arterial hypertension trials; however, women were not as well represented in coronary heart disease, acute coronary syndrome, arrhythmia and heart failure trials.

Last year, Abbott Laboratories launched a Diversity in Clinical Trials Initiative to help build a more inclusive clinical trial ecosystem. This initiative by Abbott included $5 million in funding for almost 300 scholarships to assist the next generation of ethnically diverse researchers, doctors and nurses who will lead clinical trials in the future.

Now the Illinois-based medical device and health care company has partnered with the non-profit organization Women as One to start a new program called CLIMB Research. This new partnership between Abbott and Women as One will train female and underrepresented physicians to help improve diversity in clinical trials.

Women As One has a mission to promote talent in medicine by assisting female physicians find unique opportunities in their profession.

“By advancing our training program with Abbott, we are actively increasing the number of diverse researchers in clinical trials to create a safe haven of trust to ultimately support underrepresented patients,” said Roxana Mehran, MD, Women as One founding director in Abbott’s press release.

Abbott provided $150,000 in funding for CLIMB Research to support skills training for underrepresented cardiologists. This new training program is open to underrepresented groups, including female, Native American, Black, Asian, South Asian, Hispanic and non-binary cardiologists. The program will provide training on the clinical trials process and opportunities for trainees to grow their networks, learn new skills and increase visibility with partners from industry.

XTALKS WEBINAR: Considerations for Patient Diversity in Cardiovascular Clinical Trials

Live and On-Demand: Thursday, June 02, 2022, at 10am EDT (3pm BST/UK)

Register for this free webinar to learn the common challenges associated with recruiting and retaining historically underrepresented populations in clinical trials; as well as strategies to overcome them. The featured speakers will discuss how to identify strategies to increase interest, accessibility and trial participation for patients in underrepresented populations.

When it comes to women leading cardiovascular clinical trials, a study that analyzed 200 cardiovascular trial publications from 2014 to 2018 reported that out of 2433 leadership committee members, 11.1 percent were women. Additionally, out of those 200 trials, 41.5 percent had no female investigators and 55.5 percent had no female physicians on their leadership committees.

“Through our new partnership with the Women as One CLIMB Research skills training program, we are actively changing the trajectory of how underrepresented physicians address clinical trial care for underrepresented groups,” said Lisa Earnhardt, executive vice president, Medical Devices, Abbott, in the company’s press release.

The Global Cardiovascular Clinical Trialists (CVCT) Forum is a co-sponsor of CLIMB Research 2022. The CVCT is an educational forum that focuses on the discussion of the newest and most significant cardiovascular, cardiorenal and cardiometabolic trials.

Therefore, by providing skills training to underrepresented physicians, Abbot and Women as One are helping to remove the current barriers to clinical trial leadership and participation which they report are “lack of trust, lack of access, lack of understanding and lack of a common language.”