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How do cultural and socioeconomic considerations impact clinical trial execution?

Posted by on 27 July 2017
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This extract is part of a whitepaper that asks whether patient-centricity is truly at the core of clinical trials. Download the full whitepaper for free here.

Cultural competence refers to “awareness of unique, and defining characteristics of the populations for which health professionals provide care and from which they wish to enroll clinical research participants.”1 Knowing the community and cultural background of the target population will guide the team in tailoring recruitment strategies, which may need to be adapted over time as the studies are refined.

These cultural/ethnic groups tend to have lower incomes. In a recent survey study, researchers affiliated with the National Cancer Institute Community Oncology Research Program (NCORP) found that patients with annual household incomes below $50,000 were less likely to participate in a cancer clinical trial than those with higher incomes. Low socioeconomic status is commonly associated with less education, lower literacy, lower-paying jobs, inferior or no healthcare coverage, negative experiences with the healthcare system, and poorer health outcomes. The reality is that issues such as paying for child care, immigration status, travel costs or complexity of travel, interference with work and family life, and age, all play roles in the difficulty in recruiting from low socioeconomic groups.

Language can be a significant barrier particularly with understanding the purpose of the study, filling out questionnaires and understanding informed consent. In order to be equivalent among different cultural groups, these documents need to be not only translated into the appropriate language, but they also need to be adapted to the particular culture.

WHITEPAPER: Is patient-centricity is truly at the core of clinical trials? Download here.

Many of the ethnic groups have in common a fear and distrust of conventional medicine and research. While addressing these factors may seem insurmountable, there are a number of carefully done studies that provide guidance in working with these groups. We will focus on 4 studies that provide a wide breadth of validated information as well as examples of how to approach these groups.

  1. This study examined the reasons why participation of African Americans in research studies was low and included 198 African American residents of Detroit. The results indicate that lack of trust of medical research, high importance of the race of their own doctor, belief that as minorities they bear most of the risks of medical research and whether they were familiar with the Tuskegee Study were the major impediments to clinical trial participation. The authors concluded that study enrollment should focus on building trusting relationships with minority communities2.
  2. This research project examines the recruitment and retention of healthy, community-based women in three ethnic groups: African Americans, non-Hispanic European Americans, and Mexicans/Central Americans. Of 722 women contacted and screened, 346 (48%) were eligible and consented to participate. The largest group of potential subjects was identified through broadcast media approaches, but this method produced the highest number of ineligible women and highest rate of attrition. Printed matter produced the next largest group of potential subjects, but ineligibility was high (53%). Face-to-face interactions enrolled the highest proportion of eligible women (84%) and lowest overall attrition (7%). Direct referral yielded fairly efficient enrollments (57%) and average attrition. Most importantly, attrition at 12 months was 10% which is very low compared with other published reports. They attribute the high recruitment and retention to these 6 strategies: (a) recognition of accomplishments, (b) snacks or meals provided during program, (c) diversity of staff at program site, (d) transportation or bus tickets provided, and (e) child care provided, and (d) reminder phone calls/emails about the program3. It remains unclear why individualized attention during enrollment wasn’t included as one of the factors.
  3. This study asked the question if using an existing service could recruit low-income women and men. They interviewed 225 low-income African American and Latino women who called every Woman Counts information and referral service. Despite calling about services unrelated to study participation, almost 50% (113) of women eligible for recruitment completed the screening questionnaire. Of those that fit the inclusion criteria, 58% (10) of African Americans and 35% (13) of Latinos completed an interview. Only 17% (4) of women referred a man for participation in an interview for our study. Several themes emerged from their analysis of interview data: (1) women’s role in men’s health can be significant; (2) challenges when talking to men about their health include health access, gender dynamics, and men’s fear of health care; (3) women’s understanding of research may be limited; (4) women use a range of strategies to address and overcome men’s resistance to taking care of their health and participating in research4.
  4. This last study was designed to determine a recruitment and retention strategy for a group of socioeconomically diverse African American and non-Hispanic Whites. In order to recruit the cohort of 3,722 participants, they needed to develop community partnerships, select a study topic that is directly relevant to the community, focus on providing a direct benefit for the participants, and clear communication of the research program5.

Distilled down, these studies and many others offer these recommendations for recruiting and retaining ethnic and low-income groups:

  1. Reduce participation barriers by helping meet families’ and individuals’ needs. Help meet low-income participant’s basic needs—daycare, meals, and transportation. Help meet the needs of participants by choosing a convenient location. Take time to understand the competing priorities of the low-income families and individuals you are looking to recruit.
  2. Build trust and personally connect with families and individuals. Make personal contact a priority by taking the time to develop relationships built on past positive experiences that develop trust. Seek input and feedback from program participants. Get involved with community leaders and church groups.
  3. Invest adequate resources into recruitment and use multiple strategies based on the needs of the target group. Budget enough time, money, and resources to effectively recruit participants. Include individuals who are seen as “centers of influence” and ask how potential participants want to be contacted.
  4. Clearly and non-technically explain to families and individuals how they will benefit from their participation. Let them know you appreciate their participation by providing honorariums that participants value (e.g., money, gift certificates, coupons). Provide materials in multiple languages. Hire bilingual staff or offer the use of a translator who is immediately available, if found to be needed.

Any of these recommendations require a commitment of time, money and resources that will need to be budgeted for recruitment and continued for retention. Researchers need to gain a solid understanding of the target ethnic group, which requires trust built from experiences, community engagement, and skilled research recruiters.

This is an extract from an exclusive free whitepaper that explores whether clinical trials are truly patient-centric yet. Download the full report here.

  1. O’Brien, R. L., Kosoko-Lasaki, O., Cook, et al. Self-assessment of cultural attitudes and competence of clinical investigators to enhance recruitment and participation of minority populations in research. Journal of National Medical Association. 2006;98: 674-682.
  2. Shavers VL, Lynch CF, Burmeister LF. Racial differences in factors that influence the willingness to participate in medical research studies. Annals of epidemiology. 2002 May 31;12(4):248-56.
  3. Gilliss CL, Lee KA, Gutierrez Y, et al. Recruitment and retention of healthy minority women into community-based longitudinal research. Journal of women’s health & gender-based medicine. 2001;10:77-85.
  4. Joseph G, Kaplan CP, Pasick RJ. Recruiting low-income healthy women to research: an exploratory study. Ethnicity and Health. 2007;12:497-519.
  5. Ejiogu N, Norbeck JH, Mason MA, Cromwell BC, Zonderman AB, Evans MK. Recruitment and retention strategies for minority or poor clinical research participants: lessons from the Healthy Aging in Neighborhoods of Diversity across the Life Span study. The Gerontologist. 2011;51(Suppl 1):S33-45.
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