This qualitative study was designed to understand the socio-ecological elements involved in the active implementation of minority recruitment practices for biopharmaceutical-sponsored clinical trials. The socio-ecological model guided this study, and 20 themes emerged from the data analysis and were categorized across the socio-ecological model levels.
The following section interprets the emerging themes in relation to the literature. The meaning of these findings is then discussed in relation to the socio-ecological model.
Implications for practice that have been guided by an ecological perspective and derived from the findings are provided to offer guidance and suggestions for enabling clinical research sites to effectively create an environment for recruiting minority participants. In conclusion, suggestions for future research are provided.
The literature on the topic of minority recruitment in clinical trials is in the context of NIH-funded trials, so these findings offer a new contribution to the literature related to industry- funded trials. In addition, it is important to differentiate between the support and resources that are provided to sites conducting NIH-funded studies versus those provided to industry-funded studies. In addition to individual study support, the NIH oftentimes provides funding for research activity infrastructure at sites. This includes providing strategic guidance, placing resources at sites or providing funding for hiring and training minority staff to support recruitment and educational activities (Duda et al., 2011; Cook et al., 2005; Hinton et al., 2010). The discussion that follows will focus on areas in which the study findings are similar and divergent from existing literature, outside of these differences discussed relating to the literature and support provided for NIH-funded trials.
Themes Interpreted with Literature
As previously discussed, the themes that emerged have been categorized across the socio- ecological model levels, with themes representing the “intrapersonal” and “organizational” levels found to be more prominent in this study. A reason why these two levels were more prevalent in this study is likely a result of the study design and interview questions that captured a better understanding of research site staffs’ perceptions and experiences within their organizations related to minority recruitment. Interestingly, attitudes and other intrapersonal elements
regarding minority inclusion in clinical trials from a healthcare professional perspective are not widely explored in the existing literature and are limited to PI and physician attitudes, perception of barriers and extent of or lack of focus by virtue of setting and measuring progress toward minority enrollment targets (Boden-Albala et al., 2015; Durant et al., 2007; Eggly, Barton, Winckles, Penner, & Albrecht, 2015; Howerton et al., 2007; Simon et al., 2004; Williams & Corbie-Smith, 2006).
From an organizational perspective, infrastructure barriers to minority recruitment, such as inexperience and limited funding, are discussed in the literature (Durant et al., 2014; Joseph & Dohan, 2009; Williams & Corbie-Smith, 2006). However, outside of the importance of hiring a diverse research staff, organizational contextual characteristics in relation to successful minority recruitment practices are not widely described in the literature (Etkin, Farran, Barnes, & Shah, 2012; Ford et al., 2013; The Society for Women’s Health Research & FDA, 2011; Williams & Corbie-Smith, 2006). Existing literature suggests that characteristics related to research sites may have contributed to the successful enrollment of minorities into clinical trials (Duda et al., 2011; Jimenez et al., 2013; Wright et al., 2001). Participants in this study have provided context for specific organizational characteristics that contribute toward the active implementation of
minority recruitment practices, including incorporating improving access to clinical research in an organization’s mission statement and nurturing a culture of inclusion.
Although the data that emerged from this study were not as prominent on the community level as the intrapersonal and organizational levels, there was still an abundance of data
representing the community level of the socio-ecological model. These data were provided from the perspective of the individuals who participated in this study and was primarily related to efforts they take to engage with their local communities in efforts to build trust. Most of the literature related to minority recruitment is specific to the community level of the socio-
ecological model. Many of the examples discussed in the literature share cultural or community- specific recruitment strategies that involved engaging with the local community and building trust (Ejiogu et al., 2011; Etkin, Farran, Barnes, & Shah, 2012; Germino et al., 2011; Wallington et al., 2016). The literature also provides minority patient perspectives, including motivators and barriers to clinical trial participation (Ejiogu et al., 2011; Ford et al., 2012; Ford et al., 2013; Markman, Petersen, & Montgomery, 2008; Salihu, Wilson, King, Marty, & Whiteman, 2015; Wells & Zebrack, 2008). In this study, participants discussed patient motivators and barriers to trial participation. Although this information was not collected directly from patients, the perceptions shared by this study’s participants corroborates with existing literature describing minority patient perspectives regarding clinical trials. In addition to information reported in the literature, the participants in this study provided context surrounding minority patient interest in receiving disease education and learning about clinical trials. Participants discussed building long-term trusting relationships with minority communities by providing education and empowering patients to take an active role in managing their disease. Study participants also shared their experiences related to learning about other cultures through face-to-face interactions.
At the interpersonal level, only two themes emerged from this study – teamwork and no peer influence. The existing literature related to minority recruitment in clinical trials is not inclusive of the interpersonal level of the socio-ecological model from a research provider perspective. Instead, the socio-ecological model has been used in the literature for categorizing barriers to minority participation in clinical trials and describes influencers of patients’
interpersonal relationships as opposed to researchers’ interpersonal relationships (Salihu, Wilson, King, Marty, & Whiteman, 2015; Wells & Zebrack, 2008). Thus, the themes at the interpersonal level provide new contributions to the literature.
Similarly, two themes emerged that represent the policy level of the socio-ecological model. These two themes are lack of diversity emphasis and diversity emphasis attempts made by either the trial sponsor or governing body. Due to the application of the socio-ecological model for this study, the policy level was defined to represent both public policy and clinical trial policy or expectations set forth by trial sponsors. Therefore, any expectations or lack of
expectations regarding minority enrollment on behalf of the pharmaceutical sponsor was categorized under the policy level, which broadened the opportunity for representation of this level. The clinical trial literature is not heavily saturated with policy-level representation related to minority recruitment. An abundance of literature discusses minority recruitment strategies utilized for NIH-funded studies; however, the focus of the literature is on describing the strategies used and not policy implications related to these studies having a minimum requirement for enrolling racial and ethnic minority participants as a stipulation of receiving funding (USHHS, NIH, 2001). However, some of the strategies utilized in the literature that were discussed may have been made possible due to additional funding and support. There is also literature regarding the low uptake of planning for the NIH’s mandate for minority inclusion with
regards to setting minority enrollment goals, requiring cultural competency training and translating study materials (Boden-Albala et al., 2015; Durant et al., 2007; Durant et al., 2014; USHHS, NIH, 2001). Finally, lack of access to healthcare or not having health insurance are discussed as barriers to minority participation in clinical trials (IOM, 2003; Swanson & Ward, 1995; USHHS, CDC, 2011a). While not a dominant theme, participants in this study discussed lack of access to healthcare as being both a barrier and an enabling factor toward minority participation in clinical trials.
Intrapersonal themes interpreted with literature. Participants in this study
demonstrated their personal commitment to minority recruitment by initiating self-directed action for this purpose. Based on the literature, underlying factors contribute to active minority recruitment efforts, specifically actively offering a trial to minority patients. For example, researcher perception of barriers influence whether or not minorities are offered trial
participation (Durant et al., 2007; Simon et al., 2004; Stone, Mauch, & Steger, 1998; Williams & Corbie-Smith, 2006). PI motivation also is believed to play a role in successfully recruiting minority participants (Wright et al., 2001). Researcher attitudes influence success with minority recruitment, likely because those with positive attitudes toward minority inclusion are more active in enrolling patients (Williams & Corbie-Smith, 2006). Participants in this study not only believe that clinical research is important, but also that it is important to increase minority participation in clinical trials. Participants discussed their frustration with barriers to recruiting minority participants. Based on the findings of this study, participants’ positive attitudes toward minority inclusion are fueled by their desire to ensure equitable access to treatment options available in clinical research and their frustration with barriers. These factors likely contribute to participants in this study taking an active role in minority recruitment. In addition, participants
shared their experiences that go beyond merely offering a trial and shared examples detailing ways in which they are personally committed and determined to improve minority participation in clinical trials. Participants discussed feeling satisfied with and rewarded by their jobs, more so than the industry trends reporting job satisfaction levels of clinical research professionals
(Korieth and Anderson, 2015). The participants also discussed personal growth as they undergo a continuous process of learning through their recruitment efforts. By better understanding their patients’ needs and perspectives, participants are better able to be effective at communicating cross-culturally. Existing literature does not discuss personal growth or change among clinical research staff. For participants in this study, continuous learning is important to being more effective in minority recruitment.
The limited literature discussing intrapersonal elements from a research professional perspective is confined to PI and physician attitudes and perceptions regarding clinical research or minority inclusion in clinical research. This study offers perspectives from other research professionals related to minority inclusion in clinical trials, outside of PIs. The majority of participants in this study have responsibility for recruitment within their organizations. They have positive perceptions regarding the importance of diversity inclusion in clinical research and are personally committed to actively implementing minority recruitment efforts. For research organizations focusing on minority recruitment, taking perspectives regarding diversity inclusion into account is an important consideration when making hiring decisions. When organizations focus on minority recruitment, hiring considerations for recruitment staff should include those who believe minority inclusion to be important and thus contribute to a culture of inclusivity within the organization.
Organizational themes interpreted with literature. One of the key elements to
successfully recruiting minority participants, which is supported by the literature, is education of minority communities through providing disease and general clinical trial education prior to presenting a specific trial opportunity (Etkin, Farran, Barnes, & Shah, 2012; Regnante et al., 2019; The Society for Women’s Health Research & FDA, 2011). Despite recognition of the importance of minority community education prior to study-level recruitment activities, such action is not being taken ahead of study recruitment activities nor is providing community education a common practice at the site level (Livaudais-Toman, Burke, Napoles, & Kaplan, 2014). Those research sites that are engaged in educating their local communities are providing education at the same time as trial recruitment, even when receiving NIH funding or resources (Aponte-Rivera et al., 2014; Cook et al., 2005; Germino et al., 2011; Hinton et al., 2010;
Sturgeon et al., 2018). The success and sustainability of this approach to providing education to minority communities is yet to be documented among industry-funded studies. However, NIH National Institute on Aging Alzheimer’s Disease Research Centers (ADRCs) and NCI-
designated comprehensive cancer centers provide community education to minority communities prior to introducing a clinical trial opportunity in partial fulfillment of the requirements for being recognized as a federally designated center and maintaining federal designation status (American Cancer Society, 2014; Etkin, Farran, Barnes, & Shah, 2012; USHHS, NIH, 2018, January; Regnante et al., 2019).
Surprisingly, participants in this study discussed how their organizations have made the commitment to invest in providing general disease education to minority communities prior to discussing a study, despite the fact that this is not common practice even for NIH-funded institutions (other than the federally designed ADRCs and NCI comprehensive cancer centers
that are stipulated to do so). Educational events are costly and they yield few participants (Sturgeon et al., 2018). Additionally, pharmaceutical sponsors are focusing on expediting trial enrollment (USHHS, OIG, 2000). Sponsors provide centralized recruitment support on a study- by-study basis, leaving it up to the research sites to establish a long-term commitment to community education, should they wish to do so. The extent of community education being provided by sites that conduct industry-sponsored trials is unknown, though presumed scarce or non-existent based on the literature that depicts NIH-funded research institutions as not initiating community education at all, let alone as a long-term investment (Livaudais-Toman, Burke, Napoles, & Kaplan, 2014). This clearly differentiates the participants in this study from research staff in both NIH and industry-sponsored sites. Industry stakeholders who attended a recent workshop acknowledged that although recommended, community education prior to focusing on study recruitment is not occurring with industry-sponsored studies (The Society for Women’s Health Research & FDA, 2011). Some interview respondents discussed how this concept was fairly new to them as they recently learned about the importance of community education when they started focusing on minority recruitment. They ultimately made that change to overcome barriers and commit to investing in a long-term commitment to educating their local
communities and empowering patients to understand their disease and its potential treatment options and to be comfortable with the concept of participation in a clinical trial prior to presenting a specific trial opportunity.
Individuals in this study also discussed how their organization demonstrates its
commitment to minority recruitment by investing in structural enhancements. As described in the literature, research center infrastructure impacts the successful enrollment of minority
conducting research activities (Etkin, Farran, Barnes, & Shah, 2012; Ford et al., 2013; Joseph & Dohan, 2009; Williams & Corbie-Smith, 2006). Even with these investments and having
leadership supportive of clinical research initiatives within their organizations, participants discussed continuing barriers. Many expressed the need for additional research staff members and more language capabilities, which are also discussed in the literature as limiting factors for minority recruitment (Durant et al., 2014; Joseph & Dohan, 2009). However, participants also shared examples of how their organizations have overcome barriers to improving their research infrastructures and have enhanced their capabilities to better meet the needs of diverse patients.
Participants also discussed organizational contextual characteristics in relation to implementation of minority recruitment practices, which are not widely described in the literature. Participants in this study work for organizations with a mission related to improving healthcare through clinical research, a finding that is to be expected since these organizations conduct clinical research. Improving access to clinical research is a component of the
organizational mission for many of the participants’ organizations. While the literature does not discuss the organizational mission statements of clinical research sites, the authors of one study reported that research activities are not sufficiently supported when clinical research is not incorporated into a research organization’s mission statement (Joseph & Dohan, 2009). Findings from this study suggest that both incorporating clinical research and providing access to clinical research within a research site’s mission statement are components that promote active minority recruitment efforts. This finding is supported by the fact that participants in this study discussed recruitment activities being driven by their mission. Believing in the mission was an important aspect leading to principles of working in support of carrying out their organization’s mission.
Regnante et al. (2019) reported that cancer research centers recruiting a high percentage of minority clinical trial participants demonstrate an inclusive organizational culture by
dedicating leadership roles to diversity and hiring minority staff. In addition to leadership support deriving a culture of inclusion, the organizational cultures related to this study’s participants also portray an importance and focus on minority recruitment based on co-worker attitudes and interactions. Participants’ co-workers help to create an inclusive organizational culture that is prevalent across the organization.
Another characteristic unique about the participating organizations is that they have processes that are flexible. This allows their minority recruitment approaches to change based on learnings from past experience, as individuals and their co-workers gain a better understanding of the patients being recruited and how to better adapt to those patients’ cultural preferences and needs. Crosson, Lane, and White (1999) discussed how organizational learning provides a competitive advantage. Individuals who participated in this study discussed the enhancements that were made based on organizational learning that improved their organizations’ competencies and allowed them to improve their recruitment of minority trial participants.
Community themes interpreted with literature. Although organizations conducting
clinical research may be located in diverse communities or have a high percentage of diverse patients they manage in clinical practice, this does not equate to having access to these diverse patients for clinical research. While physical access based on geography may be apparent, many barriers preclude research organizations from the successful enrollment of minority patients into clinical trials. For example, according to one study, organizational structural barriers prevented minority enrollment into clinical research within a safety net hospital that serves a high
and/or clinical research also has prevented clinical research organizations from enrolling
minority patients into trials (Corbie-Smith, Thomas, Williams, & Moody-Ayers, 1999; Durant et al., 2014; Ejiogu et al., 2011; Ford et al., 2013; Roberson, 1994; Swanson & Ward, 1995). Similarly, individuals in this study discussed how factors such as mistrust or a lack of
understanding related to clinical trials come into play that prevent them from enrolling minority patients into trials, despite having physical access to patients based on geography. Despite geographical location, it still takes time and a concerted effort to overcome the multitude of barriers that prevent successful enrollment of minority participants into clinical trials.
As mistrust is a prominent barrier, participants in this study discussed the many efforts they have taken to instill trust in clinical research, as well as a relationship of trust between research staff and minority patients. Participants discussed the need for developing and fostering long-term, trusting community relationships that start prior to and extend beyond a specific study opportunity, and this is facilitated through education. Participants and their research
organizations engage in these activities despite existing literature indicating that building trusting relationships through community education is not common practice outside of the federally designated ADRCs and NCI comprehensive cancer centers, as discussed previously (Etkin, Farran, Barnes, & Shah, 2012; Livaudais-Toman, Burke, Napoles, & Kaplan, 2014; National Academies of Sciences, Engineering, and Medicine, 2016; Regnante et al., 2019). Providing general and personalized disease education, coupled with health screenings, is a way to establish