Patient Diversity: The Elephant in the Room

23rd November 2016 (Last Updated August 23rd, 2018 10:17)

Karen Brooks, Adare Pharmaceuticals, explains why the industry must champion the benefits of clinical trials to boost participation among ethnic minorities

Patient Diversity: The Elephant in the Room

Diversity in clinical trials is no longer considered an after-thought, or something that’s nice to have. Patient diversity is now an expectation in the effort to address the ongoing challenges that remains in ensuring clinical trial participants are representative of the actual patients expected to benefit from the treatment or intervention under study. When it comes to tackling the question of the lack of diverse patients, it’s easy to ask, “How has this continued for so long?” I would like to paraphrase a response by Dr. Freda Lewis-Hall, CMO of Pfizer, who was posed this exact question during a panel discussion.  She responded, “Because we are trying to solve Star Wars problems with Flintstones’ tools”.

The topic of patient diversity in clinical trials is by no means new with many pharmaceutical and biotech companies, patient advocacy groups, patient recruitment companies, and not for profit organizations all attempting to address this issue head on. While numbers are improving in some trials and the problem is receiving greater attention, there is still much work to be done. This problem requires devoted and dedicated champions who recognize exactly what efforts need to be embedded in the culture of an organization.

Figure 1 (Karen Brooks)

The pharmaceutical industry has received the message from the Food & Drug Administration (FDA) that increasing diversity in clinical trials is a priority. The Agency has planned a variety of activities to push for greater inclusion, and more minority participation. This stated priority is the result of decades of underrepresentation of ethnic and racial minority groups in clinical drug trials and researchers continue to try and understand why minority participation is low.

In recognition of this stated priority, the FDA developed the Drug Trial Snapshot, a website designed to provide demographic information from clinical trials to consumers through its easy-to-read webpage. For example, since the inception of the website, approximately 16 cancer-related treatments were approved and listed. The inclusion of the trials ranged from <1 percent to 12 percent of African American/Blacks (AA/Blacks). Unfortunately, the majority (80 percent) of the trials were less than 4 percent AA/Black participants. Now this might not seem as a low number, but in context with a US population of approximately 13.6 percent self-identified AA/Blacks, and the increased disparity of AA/Blacks (for all cancers combined, the death rate is 25 percent higher for AA/Blacks than for Whites) with cancer death rates, these inclusion percentages are not sufficient.

Despite the ongoing efforts to increase AA/Blacks in cancer clinical drug trials, this group continues to be underrepresented.  A gamut of peer research has noted multiple reasons for low participation and lack of willingness among AA/Blacks to participate in cancer clinical drug trials. In an effort to complement and contribute to these findings, I completed a research survey study as a part of my doctoral research that focused on AA/Blacks and their willingness to participate in cancer clinical drug trials.

In total, the survey was conducted on 187 AA/Blacks that have or had cancer. The data clearly presented an association between knowledge and the benefit of clinical trials, as well as the level of trust to AA/Black cancer patients’ willingness to participate in cancer clinical drug trials. Individuals that truly understood the meaning of a clinical trial as well as the benefit of participation, and those with a higher trust score of medical research were more willing to participate in cancer clinical drug trials.

In addition, individuals who did not understand what a clinical trial consists of or who did not agree that there is a benefit were also less trusting of medical research. Only 51 percent were somewhat knowledgeable on cancer clinical drug trials and the potential benefits to participation.

This study provides positive evidence that there is an opportunity to educate the AA/Black community and this education will directly correlate to increased participation.

The minority patient journey to clinical trial participation originates with all industries increasing awareness of clinical trials in the minority community. This can happen through patient interaction campaigns and involvement of all minority health care providers and minority serving institutions. Increased awareness improves access to patients not currently being approached through collaborations and partnerships. This access also allows us the opportunity to educate diverse populations through patient engagement about clinical trials; education enhances knowledge. The power of knowledge provides understanding and understanding a clinical trial and its benefits builds rapport. Rapport with minority communities cultivates trust. Most importantly, trust among AA/Blacks promotes consideration, and if more minorities are considering clinical trial participation as an option in their treatment journey while they have access, this will lead to increased minority representation.

 

*Karen Brooks is the Senior Director Clinical Operations at Adare Pharmaceuticals

 

References

http://www.fda.gov/Drugs/InformationOnDrugs/ucm412998.htm

http://blogs.fda.gov/fdavoice/index.php/2016/01/2016-the-year-of-diversity-in-clinical-trials/

http://www.cancer.gov/about-nci/organization/crchd/cancer-health-disparities-fact-sheet