From The Editor | May 26, 2021

Discussions On Diversity – How To Solve Pharma's Patient Problem

Ed Miseta

By Ed Miseta, Chief Editor, Clinical Leader
Follow Me On Twitter @EdClinical


Clinical trials need to become more diverse. I think everyone reading this will agree with that statement, although many might disagree on the path to get there. The COVID-19 pandemic has shed a light on inequities that exist in healthcare and clinical trials, which need to be solved before the industry can recruit a more diverse patient population and site network into its studies.

PAREXEL has released a report titled Discussions on Diversity, which contains learnings from an extensive series of global surveys, focus group sessions, interviews, and Patient Advisory Council meetings. The report highlights feedback from patients, the general public, and physicians who were willing to engage in candid discussions on the topic of racial and ethnic diversity in clinical trials.

While some of these findings may not be a surprise to many in the industry, especially those who work in patient recruitment, they certainly highlight the challenges that exist and the work that needs to be done to build a more diverse patient population.

First Build Trust

Many patients surveyed expressed mistrust and skepticism around participation in clinical trials. The mistrust was attributed to negative historic events in research, as well as experiences with physicians who may not understand the needs of racial and ethnic groups. The key takeaway on this point is that sponsors need to successfully engage with patients and their families. To do so, they will need to establish trustworthy relationships with doctors, community advocates, and leaders from underrepresented communities. Those conversations will build trust and lead to better relationships between the groups.

The topic of COVID-19 was also front-and-center in the surveys. Physicians noted they expected low vaccine trial participation rates from diverse communities.  They cited lack of trust in the pharmaceutical industry and prevailing negative perceptions around infectious disease as the primary reasons. Those same physicians also expected a low uptake of the vaccines themselves, especially in African American communities. That expectation was based on their experience with previous flu vaccination programs.

Change Your Clinical Model

The report notes research participants noted there is a degree of stigma around illness in some communities. That was viewed as a contributing factor for lower levels of research participation. Being aware of these disease perceptions and making accommodations for them could help with trial recruitment. For example, deploying a decentralized trial model could increase access to research while maintaining the privacy of patients.

There are also practical barriers to trial participation that sponsors can easily overcome. The report suggests providing clinical trial information to participants in their primary language is important. The information should also be presented in clear, nontechnical terms. There are other practical barriers, such as financial concerns, childcare, and transportation that can serve as participation barriers regardless of race or ethnicity. All are issues that sponsors can easily overcome. Those barriers were also cited by a greater proportion of Black, Latino, Asian, and indigenous research participants. Research access can be greatly improved with consistent reimbursement for time and travel and making the trial more convenient for participants.

More Diverse Sites

Creating greater diversity at sites could also assist trial recruitment. Research participants noted that receiving treatment from site staff of the same race, ethnicity, or cultural background was important to them. When that is not possible, understanding and accommodating differences in cultural norms would help patients and care givers feel more comfortable. That should start with implementing cultural competency training that will increase trust and ensure the right treatment decisions are being made.

Research participants also addressed opportunities available to both patients and physicians, noting those of color do not have access to the same opportunities as their white counterparts. Those findings indicate societal and institutional changes are required to level the training field. The absence of representation by blacks in the pharma industry has also led to a lack of trust by some physicians. The lack of trust then results in a lower participation rate of black physicians serving as clinical trial investigators.

 To increase the involvement of physicians in clinical research, more education is needed. Physicians who participated in the surveys indicated a key challenge is knowing how to become involved in clinical research. Factors that could increase their rate of participation include long-term mentorships, adequate financial compensation, guidance, and training. The guidance and training should be provided early in a physician’s career path by someone with experience.

 Those efforts will require support and funding, including assistance from the pharma industry. One important step would be involving new sites in clinical research. That effort could reach physicians working in community hospitals with access to patients who may otherwise not have the opportunity to participate in clinical research.

Finally, the report states there needs to be a greater focus on diversity in the site selection process. Proactively collecting information on the race and ethnicity of site staff and patients will provide the data necessary to take an evidence-based approach to continuous improvement. That effort will need to take place in countries where it is permissible and be conducted in a sensitive manner, but if done correctly can ensure a diverse representation in clinical trials.

To access the Discussions on Diversity Report or an executive summary, go here.