Bernadette Tosti

	Despite the well-established differences in disease incidence and responses to certain drugs between racial and ethnic groups, clinical trials often fail to mirror ‘real world’ patient populations.

 This increases the risk of unexpected adverse events (AEs) when products are eventually approved, with one study finding that 6.5 % of emergency hospital admissions were due to AEs.

 For example, consider that African Americans comprise 12 % of the population in the United States, but account for only 5 % of clinical trial participants. Hispanics account for 16 % of the total population but comprise just 1 % of clinical trial populations.

	Clinical trials that do not represent the full diversity of the population may also potentially fail to identify particular groups who could benefit from experimental drugs. While African American men are twice as likely to die from prostate cancer as Caucasians, they represent only 4 % of participants in prostate cancer clinical trials.

 Similarly, cancer is the leading cause of death for the Asian-American population, yet Asian Americans represent less than 3 % of clinical trial participants.

	Against this backdrop, the need for improved recruitment of minorities to clinical trials is clear. Key challenges to overcome include:

		Lack of access to affordable healthcare insurance for many low-income populations, which may include minorities, can limit interactions with healthcare professionals, reducing the chance of becoming aware of clinical trials and their potential as a valuable care option

		Some minorities may work in hourly jobs that provide less scheduling flexibility, and raises the likelihood of losing pay to attend clinical trial appointments

		Less than 1 % of the U.S. population participates in clinical trials, and yet 72 % say they would participate in a clinical trial if recommended by their doctor.

 There is a need for improved community education about the realities and patient protections of current clinical research protocols.

	In response, clinical trial sites have identified a range of best practices for recruiting minority participants (Figure 1). Multifactorial approaches include identifying and working with sites that have minority and multilingual staff, making the environment more welcoming for minorities and individuals whose first language is not English. To connect with patients in minority communities and win their trust, communicating through physicians and clinics is only a first step. Popular community gathering locations should be considered as part of a recruitment plan, along with participating in local events such as health fairs. To be effective, handing out flyers or posting ads is not enough. The best results come from face-to-face engagements, where study staff can take an opportunity to educate people about clinical research, answer questions, allay fears and talk about the value of participation. Specific study information can also be communicated through targeted media. Furthermore, clinical trials can be made more accessible for patients by offering assistance with transportation, childcare and dependent care.

Figure 1: Multifactorial challenges require multifactorial solutions

	When partnering with biopharma study sponsors, it is essential to clarify the level of commitment to a specific study or program requiring targeted minority recruitment, and be willing to try innovative approaches and provide additional resources to attain enrollment targets. Decision-making should involve senior leadership as well as diversity officers, with an emphasis on the importance of long-term relationships with external advocacy groups, patient advocacy groups and medical associations. The best practice is to build an internal infrastructure to address minority recruitment rather than repeatedly setting up 

	In conclusion, the approaches described above can help build a dialogue with target minority populations to improve study sponsors’ understanding and accommodation of varying lifestyles and specific population needs within study protocols. This is an essential step towards ensuring that clinical trial populations more closely reflect the real world where new drugs will be used. Equally important, these approaches can also benefit minority patients by improving their awareness and access to clinical trials as a valuable care option.

Senior Director, Head of Patient Recruitment Programs, Quintiles

 www.fda.gov/downloads/ScienceResearch/SpecialTopics/WomensHealthResearch/UCM334959.pdf

http://www.ncbi.nlm.nih.gov/pubmed/15692274

http://www.ncbi.nlm.nih.gov/pubmed/15231615

http://www.cancer.gov/about-nci/organization/crchd/cancer-health-disparities-fact-sheet#q9

 Research!America National Poll  on Clinical Research conducted in partnership with Zogby Analytics, May 2013; N=1,006

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Bernadette Tosti

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Improving Minority Recruitment in Clinical Trials