Journal of Health Communication, 20:88–96, 2015 Copyright # Taylor & Francis Group, LLC ISSN: 1081-0730 print/1087-0415 online DOI: 10.1080/10810730.2014.908985

Barriers to Medical Research Participation as Perceived by Clinical Trial Investigators: Communicating with Rural and African American Communities ANDREA TANNER1, SEI-HILL KIM1, DANIELA B. FRIEDMAN2, CAROLINE FOSTER1, and CAROLINE D. BERGERON2 1

School of Journalism and Mass Communications, University of South Carolina, Columbia, South Carolina, USA Department of Health Promotion, Education, and Behavior, Arnold School of Public Health, University of South Carolina, Columbia, South Carolina, USA 2

Clinical trials help advance public health and medical research on prevention, diagnosis, screening, treatment, and quality of life. Despite the need for access to quality care in medically underserved areas, clinical trial participation remains low among individuals in rural and African American communities. This study assessed clinical trial research in South Carolina’s five main academic medical centers, focusing specifically on clinical trial investigators’ perceived barriers to recruitment in the general population and in rural and African American communities. Online survey responses (N ¼ 119) revealed that it was most difficult for investigators to recruit from rural areas and that rural residents were least likely to be represented in medical research, behind both the general public and African Americans. Barriers focusing on communication or awareness proved to be the biggest hurdles to finding potential participants in both the general public and rural communities. Psychological barriers to recruitment were perceived to be most prevalent in African American communities. Study findings provide important insights from the perspective of the clinical trial investigator that will aid in the development of effective communication and education strategies for reaching rural and African American residents with information about clinical trials.

Although clinical trials (CTs) help advance public health and medical research, the recruiting of people to participate in these studies is difficult for CT investigators and staff. CT researchers enroll not only patients with a particular disease (e.g., cancer) but also healthy individuals in order to study topics such as early detection of disease or health education and prevention. Regardless of the type of trial, studies consistently show that less that 10% of patients participate in CT research, a proportion that has remained largely unchanged since the 1980s (M. A. Friedman & Cain, 1990; Go et al., 2006; Klabunde, Springer, Butler, White, & Atkins, 1999; Lippman & Chabner, 1986; Ravikoff, Cole, & Korzenik, 2012; Weckstein et al., 2011). CT participation is particularly low in medically underserved communities, including African American groups and people who live in rural areas (Baquet, Commiskey, Mullins, & Mishra, 2006; Christian & Trimble, 2003; G. I. Cohen, 2003; J. G. Ford et al., 2005; M. E. Ford, Havstad, & Tilley, 2003; Giuliano et al., 2000; Guadagnolo et al., 2009; Royal et al., 2000). At the same time, rural citizens and African Americans experience significant health Address correspondence to Andrea Tanner, School of Journalism and Mass Communications, Office 4011C, University of South Carolina, Columbia, SC 29208, USA. E-mail: [email protected]

disparities, with factors such as limited access to health care services, lower rates of health insurance, lower socioeconomic and educational status, and cultural and social differences contributing to these disparities (Baquet et al., 2006; Brown, Fouad, Basen-Engquist, & Tortolero-Luna, 2000; Brown & Topcu, 2003; Christian & Trimble, 2003; J. G. Ford et al., 2005; M. E. Ford et al., 2003; Frank, 2004; D. B. Friedman, Corwin, Rose, & Dominick, 2009; Langford, Resnicow, & An, 2010; Moinpour et al., 2000; Pinto, McCaskill-Stevens, Wolfe, & Marcus, 2000; Sateren et al., 2002; Shavers, Lynch, & Burmeister, 2002). Given that CTs can provide individuals with the most advanced medical treatments and screening options, rural and African American populations may represent those who need the opportunity the most. Numerous studies have examined the barriers to CT enrollment from the perspective of the patient or local physician (Comis, Miller, Aldige, Krebs, & Stoval, 2003; Ellis, Butow, Tattersall, Dunn, & Houssami, 2001; M. E. Ford et al., 2003; Hudson, Momperousse, & Leventhal, 2005; Klabunde et al., 1999; Lara et al., 2001; McComas et al., 2010; Ravikoff et al., 2012; Shavers et al., 2002; Stone, Mauch, & Steger, 1998; Yang et al., 2010). Few studies, however, have examined barriers to recruiting individuals into CTs from the perspective of the CT investigator, who is largely responsible for communicating about specific

Barriers to Medical Research Participation CTs and recruiting eligible participants. Because medical researchers often do not understand their target population or recognize the importance of tailoring information in a manner in which it will be well received by individuals in a particular community (Vesey, 2002), CT investigators’ preconceptions of the difficulty in enrolling participants from underserved populations may impede effective recruitment among this large pool of potential CT participants. Because finding the most effective manner in which to recruit CT participants is a key issue for health care practitioners and health communication researchers, we seek to address this gap in the literature through an attempted census of principal investigators1 involved in CT research at academic medical centers in the state of South Carolina, a state with a sizeable African American population that is also largely rural.2 The primary goal of this research is to examine CT investigators’ perceived barriers to recruitment in the general population and in African American and rural populations. Findings address the important question of how best to communicate with potential CT participants who live in underserved communities.

Barriers to Participation in Clinical Trials in Rural and African American Communities Beyond being clinically disqualified, potential CT participants are excluded from CTs for a number of structural and procedural reasons, including the extra time and effort required for participating in trials (Comis et al., 2003), lack of insurance or insurance denial (Brown et al., 2000; Brown & Topcu, 2003; Comis et al., 2003) and medical providers who are reluctant to engage in, or are unaware of, ongoing trials (Comis et al., 2003; Frank, 2004). Lack of sufficient infrastructure is a major barrier to CT accrual in rural areas (Sateren et al., 2002). CTs are often less available in underserved areas (Baquet et al., 2006; Guadagnolo et al., 2009) and rural areas also represent poor accessibility to care (Shavers et al., 2002). The lower socioeconomic status of the rural poor makes them more sensitive to the additional costs and time often required for participating in CTs. These structural and procedural barriers are also prevalent in African American communities (Adams-Campbell et al., 2004; Gross, Filardo, Mayne, & Krumholz, 2005; McCaskill-Stevens et al., 1999; Pinto et al., 2000; Sateren et al., 2002). Cognitive barriers may also contribute to low enrollment in clinical trials (G. I. Cohen, 2003; Ellis et al., 2001; Quinn et al., 2007) with at least 40% of Americans reporting lack of 1 Although 83% of respondents self-identified as principal investigators, others self-identified as managers, project managers, recruiters, research associates, nurses, or ‘‘other.’’ Because of these individuals’ close work with CT recruiting, all of these respondents, regardless of their role, were included in our analyses. 2 According to the U.S. Census Bureau, African Americans comprise 28.2% of the South Carolina population and 12.9% of the national population. Furthermore, 25 of South Carolina’s 46 counties are designated as nonmetropolitan (i.e., rural), with 39.5% of the state’s population living in rural areas, compared with 21% of the national population living in rural areas.

89 awareness and understanding about the idea of a clinical trial (Comis et al., 2003; Langford et al., 2010). Several studies have demonstrated that CT knowledge is significantly correlated with willingness to participate (Comis et al., 2003; Ellis et al., 2001). In African American communities, cognitive barriers most often consist of limited CT awareness or education (Advani et al., 2003; Lara et al., 2005; Trauth et al., 2005). Psychological barriers to CT participation include misperceptions, distrust, and fear. There are misperceptions that standard therapy is the best and that CT patients are treated like guinea pigs (Frank, 2004). Equally typical is the perception that patients agree to participate only if their condition is terminal (Quinn et al., 2007). Another barrier is the lack of public confidence in medical research (Giuliano et al., 2000; Shavers et al., 2002). Misperceptions, combined with general distrust of medical research, can also produce fear among potential participants (Brandon, Isaac, & LaVeist, 2005; Branson, Davis, & Butler, 2007; Chandra & Paul, 2003; J. G. Ford et al., 2005; Quinn et al., 2007; Seto, 2001; Shavers et al., 2002). Patients are often fearful of possible negative effects of being tested with unproven protocols or therapies (D. R. Brown et al., 2000; Jones et al., 2006) or of losing control over treatment (Frank, 2004). Furthermore, historical abuses of research participants have contributed to the skepticism about CTs, particularly among minority populations (G. I. Cohen, 2003; Kelch, 2002). Abuses in the past, such as the Tuskegee syphilis study (Thomas & Quinn, 1991), combined with perceived discrimination, indifference and disrespect, have contributed to the distrust and fear of the medical care system among rural and minority populations (Frank, 2004). Comis and colleagues (2003) note that understanding and responding to the public’s attitudes toward CTs are a crucial step toward recruiting participants into future CTs. Vesey (2002) maintained, however, that investigators’ poor understanding of communities’ perceptions about CTs often leads them into a practice of planning for rather than planning with underserved communities, resulting in poor CT participation in these communities. Thus, an underlying assumption of this study is that investigators’ attitudes and beliefs about CT recruitment are important because they may influence how they communicate about CTs, in general, and when recruiting for a specific study. Therefore, the overall objectives of this study are as follows: (a) to assess CT investigators’ perceptions regarding recruitment and representation of participants for CT research and (b) to examine CT investigators’ perceived barriers to CT participation. Guided by the body of literature that examines barriers to CT enrollment in medically underserved populations from the perspective of the patient or local physician (Baquet et al., 2006; Christian & Trimble, 2003; D. J. Cohen & Crabtree, 2008; G. I. Cohen, 2003; J. G. Ford et al., 2005; M. E. Ford et al., 2003; Giuliano et al., 2000; Guadagnolo et al., 2009; Royal et al., 2000), we were particularly interested in assessing investigators’ perceived barriers by population (i.e., recruiting from the general public versus recruiting from rural and African American communities).

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Further, we explored the relations between perceived barriers to CT recruitment and contextual variables (i.e., years of CT experience, primary funding source, and role in CT research).

Method To obtain names and e-mails to administer our online survey, we first developed a sampling frame, as efforts to locate contact information for CT principal investigators working in South Carolina’s five main academic medical centers revealed no such resource. These medical centers are all affiliates of Health Sciences South Carolina, a statewide biomedical research collaborative committed to transforming South Carolina’s public health and economic well-being through research (http://www.healthsciencessc.org). The ClinicalTrials.gov website, which provides current information about federally and privately supported CTs for a wide variety of diseases and conditions, provided contact information for the sponsor of the trial and not the contact information for investigators conducting the trials. Therefore, we contacted individual institutions’ research offices to ask for the information. These phone calls and e-mails resulted in a partial database of CT principal investigators (i.e., names and e-mail contacts for principal investigators from two of the member institutions). South Carolina’s teaching hospitals provided principal investigator information on their websites, and these contacts were added to the sampling frame.3 Some South Carolina hospitals and medical centers not engaged in teaching did not have principal investigator contact information publicly available, and administrators at these nonteaching institutions were unwilling to directly release this information. To complete the sampling frame, we negotiated agreements through the individual institutions’ institutional review board offices to distribute our online questionnaire by e-mail sent from the institutional review board directors to the hospitals’ principal investigators. We obtained names and e-mail addresses for 155 principal investigators from the Medical University of South Carolina and the University of South Carolina (schools of medicine, pharmacy and public health, along with the University of South Carolina’s Sponsored Awards Management Group); 29 from Spartanburg Regional Healthcare Center; 16 from Palmetto Health in Columbia, South Carolina; and 217 from the Greenville Hospital System. A total of 417 principal investigators were included in our sampling frame. In June and July 2011, an e-mail was sent to each principal investigator requesting his or her participation in a web-based survey. A link to the online questionnaire was included in the e-mail. Three follow-up e-mails, spaced approximately 1 week apart, were also sent to obtain a high level of response. After nonworking e-mail addresses were purged from the list (n ¼ 35), the revised sampling frame 3

These contacts were available to the public at (http://scresearch. org/studies/browse/by_researcher; http://academicdepartments.musc.edu/ faculty/directory) and were added to the sampling frame database.

included 382 principal investigators. Ultimately, 119 (31% of working addresses) respondents participated in the survey and completed the online questionnaire. Where the reported sample is fewer than 119, it indicates that not all respondents answered all the questions. In most cases this was because it was not relevant to the respondent and the online survey software automatically omitted the question, but in other cases the respondent may have forgotten to answer or chosen not to answer. Survey Development and Dissemination We administered the survey instrument using the online survey tool Qualtrics, a subscription-based survey site that provides tools for instrument construction, dissemination, and data collection for researchers in industry and academia (Qualtrics.com). The survey instrument employed a combination of open and closed-ended questions and was approved by the University of South Carolina’s Institutional Review Board. Experience with recruitment was also assessed on the questionnaire. Using a 5-point Likert scale ranging from 1 (not at all represented) to 5 (very well represented), respondents were asked about the groups they believe are underrepresented in CT research, including people from rural areas and African Americans. Respondents were also asked how difficult it is to find people, in general, and from rural areas and African American communities in particular to participate in their own CT research, reported on a 5-point scale ranging from 1 (strongly disagree) to 5 (strongly agree). Respondents were also asked whether they make extra effort to recruit from rural areas and African American communities in South Carolina. Next, a battery of questions ascertained CT investigators’ perceptions of the barriers to CT recruitment, in general, and in the African American and rural communities. For each set of questions, respondents were asked to rate their level of agreement (from strongly disagree to strongly agree on a 5-point scale) with 13 possible barriers to recruitment, including problems with finding participants, insurance coverage, physicians’ knowledge of ongoing trials and willingness to recruit, patients’ lack of knowledge about trials, lack of access to trial sites, lack of literacy and=or understanding about trials, negative perceptions about trials, and=or desire for other treatments. The extensive literature on barriers to CT participation was used to develop these questions (Baquet et al., 2006; D. R. Brown & Topcu, 2003; Christian & Trimble, 2003; Ellis et al., 2001; Frank, 2004; Giuliano et al., 2000; Hudson et al., 2005; Jones et al., 2006; Klabunde et al., 1999; Lara et al., 2005; Leitch et al., 2005; Meropol et al., 2007; Ravikoff et al., 2012; Weckstein et al., 2011). Several demographic and contextual variables were also assessed. For example, principal investigators were asked about their credentials (e.g., M.D., Ph.D., R.N., M.A.) and years of experience. Respondents were also asked with which of the five South Carolina medical centers they were affiliated and how their research was funded (e.g., federal, private, state, institutional, or ‘‘other’’). Respondents were asked about their experience with CTs. Specifically, they

Barriers to Medical Research Participation were asked to indicate the number of trials they had worked on in the past 2 years: (1–3), (4–6), (7–9) or (10þ), the types of trials conducted (i.e., prevention, screening, diagnosis, treatment, quality of life and expanded access) and the focus of the CT in terms of disease or condition (e.g., cancer, diabetes, reproductive health, mental health). Analysis Descriptive statistics and frequencies were generated as well as paired-sample t tests. To analyze responses by contextual factors, frequencies and chi-square analyses were conducted. All statistical analyses were generated with SPSS Version 18, a computer-based statistical software.

Findings Descriptive Characteristics of Respondents The 119 respondents reported a broad range of CT experience and research activities. When asked about their primary role in CT research, 83% (n ¼ 99) of respondents self-identified as a principal investigator, a CT manager, project manager or recruiter (12%, n ¼ 15), research associate (4%, n ¼ 5), nurse (3%, n ¼ 3) or ‘‘other’’ (4%, n ¼ 5).4 Years of experience working with CTs ranged from 1 to 40 years, with a mean of 11.3 years. In the past 2 years, 42% (n ¼ 44) of respondents indicated that they had worked on 1 to 3 CTs, 31% (n ¼ 32) worked on 4 to 6, 12% (n ¼ 12) worked on 7 to 9 and 15% (n ¼ 16) worked on 10 or more CTs. Forty percent of respondents (n ¼ 40) said that they receive funding for CT research from private industry, followed by federal funding (37%, n ¼ 37). Other funding sources included internal institutional funding (11%, n ¼ 11) and ‘‘other’’ (12%, n ¼ 13), which included foundation and cooperative group funding. Cancer (n ¼ 66) was most often identified as the specific disease or condition being studied, followed by reproductive health (n ¼ 32), cardiovascular disorders (n ¼ 30), and diabetes (n ¼ 20). The most common focus of CT research at South Carolina’s main academic centers was treatment of illness or disease with nearly three quarters (71%, n ¼ 85) of respondents indicating that they conducted at least one trial focusing on treatment in the past 2 years. This was followed by prevention (34%, n ¼ 41), quality of life (31%, n ¼ 37), and diagnosis (29%, n ¼ 33). Regarding investigators’ perceptions about recruitment and representation of participants for CTs, as shown in Table 1, respondents (n ¼ 93) indicated that it was most difficult to find rural residents to participate in CTs, followed by the general public and African American residents. Significant differences were found between the perceived difficulty in finding rural residents as related to participants from African American communities, t(83) ¼ 4.255, p < .01; and the general public, t(86) ¼ 2.985, p < .01. 4 Percentages add up to more than 100% because respondents could identify with more than one role.

91 Table 1 also shows that rural residents’ representation in CT research is perceived to be lower than that of the general public, t(83) ¼ 9.375, p < .001; and African Americans, t(84) ¼ 10.673, p < .001. African Americans’ representation in CTs is perceived to be lower than that of the general public, t(84) ¼ 7.768, p < .001, and rural residents’ representation in CT research was perceived to be lower than that of African American representation, t(88) ¼ 3.028, p < .005. Furthermore, just more than one third of respondents (36%, n ¼ 33) indicated that they make extra effort to accrue participants from rural areas of South Carolina. Investigators’ perceived barriers (n ¼ 93) to CT recruitment were also examined. Table 2 shows that lack of information about available trials (M ¼ 3.76) was the top barrier to general CT participation, followed by local doctors being unaware of ongoing trials (M ¼ 3.74) and patients’ lack of knowledge about the idea of CTs (M ¼ 3.73), reported on a 5-point scale ranging from 1 (strongly disagree) to 5 (strongly agree). The biggest perceived barriers to rural participation were lack of information about available trials (M ¼ 3.99), local doctors unaware of ongoing trials (M ¼ 3.92), and limited accessibility to trial sites (M ¼ 3.91). Perceived barriers to African American participation included negative perceptions (M ¼ 3.93), fear of CT participation (M ¼ 3.93), and a lack of confidence or distrust in medical research (M ¼ 3.91). We also assessed investigators’ perceived barriers by population (i.e., barriers to recruiting in the general public versus barriers in the rural or African American communities; n ¼ 93). As Table 2 illustrates, means with different superscripts differed significantly at p < .05, and rural residents were significantly more likely to be perceived as having limited accessibility to trial sites: for general public by rural, t(84) ¼ 4.380, p < .001; for rural by African American: t(80) ¼ 4.891, p < .001; and having more difficulty finding doctors who are willing to engage in accrual: for general public by rural, t(84) ¼ 4.625, p < .01; for rural by African American, t(79) ¼ 3.321, p < .01. Respondents also said that it was more difficult to find doctors to engage in accrual in the African American community than in the general population, t(81) ¼ 2.017, p < .05. Lack of information was significantly more likely to be a barrier in rural communities than in the general population, t(85) ¼ 2.913, p < .01, and ‘‘local doctors unaware of ongoing trials’’ was a bigger perceived barrier for rural communities than in African American communities, t(81) ¼ 2.696, p ¼ .05. Rural residents were significantly more likely than the general population to be perceived as lacking knowledge about CTs, t(84) ¼ 2.105, p < .05, and desiring other treatments, t(85) ¼ 2.015, p < .05. Rural residents, t(85) ¼ 2.058, p < .05, and African American residents, t(81) ¼ 2.187, p < .05, were perceived to have lower literacy than the general population. Psychological barriers, including negative perception about CTs, lack of confidence in medical research, and fear of participation were more likely perceived to be a barrier in the African American population than with the rural and general population.

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Table 1. Perceptions regarding recruitment and representation of participants for clinical trial research It is difficult to find potential clinical trial participantsa

General public Rural areas African Americans

Underrepresentation in clinical trial researchb

M

SD

M

SD

3.30 3.60 3.15

0.99 0.93 0.99

3.74 2.40 2.66

0.87 0.97 0.94

Note. Respondents could identify with more than one type of clinical trial. a Participants responded on a 5-point scale ranging from 1 (strongly disagree) to 5 (strongly agree). b Participants responded on a 5-point scale ranging from 1 (not at all represented) to 5 (very well represented).

Table 2. Perceived barriers to clinical trial participation, by population (general public, rural, and African American) General public Barriers to recruiting for clinical trials

M

Patients lack information about available trials. Local physicians=doctors are unaware of ongoing trials. Patients lack knowledge (understanding) about the idea of clinical trials. Patients have limited accessibility to trial site. Patients’ insurance will not cover clinical trial procedures or drugs. Patients have negative perceptions about clinical trials (e.g., ‘‘I will be treated like a guinea pig.’’). Patients have low literacy or low health literacy. Patients have fear of participating in clinical trials. Patients lack confidence in medical research. Patients desire other treatments. Local physicians=doctors are unwilling to engage in accrual.

SD

Rural residents M

SD

a

b

3.76 3.74ab 3.73a 3.50a 3.46a 3.46a

.830 .917 .874 .966 1.04 .965

3.99 3.92a 3.89bc 3.91b 3.42a 3.63b

3.43a 3.41a 3.23a 3.23a 3.14a

.914 .888 .950 .903 .99

3.60b 3.62b 3.52b 3.37bc 3.58b

African Americans M

SD

.728 .707 .787 .946 1.02 .895

ab

3.88 3.71b 3.81ac 3.56a 3.33a 3.93c

.760 .672 .808 .876 .961 .828

.83 .77 .850 .704 .891

3.66b 3.93c 3.91c 3.41ac 3.32c

.835 .872 .864 .769 .954

Note. Means with different superscripts differ significantly at p < .05; means with the same superscript are not significantly different. Paired-samples t tests were used. Items were reported on a 5-point scale ranging from 1 (strongly disagree) to 5 (strongly agree).

These psychological barriers were also perceived as affecting the rural community more than the general public.5 We also examined patterns in responses on the basis of contextual factors such as years of clinical trial experience, primary funding source, and role in clinical trial research. Respondents with federally funded CTs (n ¼ 37) were significantly more likely, v2(3) ¼ 9.325, p < .03) to make extra effort to accrue participants from rural areas of the state (54%, n ¼ 20) than those with funding from private industry (24%, n ¼ 9) or funding from within their institution (22%, n ¼ 2). Respondents with federally funded CTs were also significantly more likely, v2(12) ¼ 25.434, p < .02, to believe that it is ‘‘difficult’’ or ‘‘very difficult’’ to recruit participant from rural areas than investigators with private funding (67%, n ¼ 24 vs. 47%, n ¼ 18).

5 Negative perceptions: general public by rural, t(85) ¼ 2.397, p < .002, general public by African Americans, t(81) ¼ 5.121, p < .001, rural by African Americans, t(80) ¼ 3.730, p < .001. Lack of confidence: general public by rural, t(85) ¼ 3.847, p < .001, general public by African Americans, t(81) ¼ 7.324, p < .001, rural by African Americans, t(80) ¼ 4.830, p < .001. Fear of participation: general public by rural, t(85) ¼ 3.152, p < .002, general public by African Americans, t(81) ¼ 6.306, p < .001, rural by African Americans, t(80) ¼ 4.069, p < .001.

Discussion This study is based on the idea that it is critical to understand CT investigators’ perceptions about representation and barriers to recruitment of participants for medical research, since it is these investigators who are responsible for communicating with the public about specific trials and recruiting eligible participants. As such, there are a number of key findings that deserve discussion and explanation. The volume of CTs taking place in South Carolina is large, with roughly more than 400 CTs conducted at South Carolina’s five main academic medical centers in the past two years. These CTs primarily focus on the treatment of illness, followed by prevention and diagnosis of illness. It is interesting that the focus of a majority of these trials (i.e., cancer, cardiovascular disease and diabetes) is in line with some of the largest health disparities in the state. For example, heart disease is the leading cause of death and disability in South Carolina (South Carolina Department of Health and Environmental Control, 2010), South Carolina is ranked 10th in cases of diagnosed diabetes compared with other states (South Carolina Department of Health and Environmental Control, 2009), and racial disparities in rates of most cancers are among the largest of any chronic disease in the nation and, in some instances, the world

Barriers to Medical Research Participation (Adams et al., 2006; Drake et al., 2006; Hebert, Elder, & Ureda, 2006; Hebert et al., 2011). Not only do study findings illustrate a need for individuals to participate in these trials, but they also demonstrate that South Carolina residents— rural and African American citizens in particular—are often overlooked during recruiting. A key finding centered on communication and lack of awareness about CTs. Barriers focusing on communication proved to be the biggest hurdles to finding potential CT participants in both the general public and rural communities. For example, ‘‘lack of information about available trials’’ and ‘‘doctors unaware of ongoing trials’’ were the top perceived barriers to recruiting in general and for recruiting in rural areas. As Frank (2004) pointed out, lack of information about the notion of CT research can impede participation. With a reported 40% of Americans lacking understanding of the idea of a CT (Comis et al., 2003), CT investigators should devote time and resources to communicating about medical research. Future research should assess the communication strategies currently employed by CT investigators, as these strategies appear to be inadequately informing individuals, particularly those in rural communities, about CTs. It is troubling that investigators believe that there is a lack of communication between themselves and local doctors, especially since findings also indicated that principal investigators perceive local doctors as willing to recruit. Together, these results suggest if communication strategies were in place to adequately inform local doctors about trials being conducted in South Carolina’s main academic medical centers, more potential participants would be identified and accrued into appropriate CTs. Physician referral is one of the most effective means of recruiting patients for CTs (Hudson et al., 2005), but findings from the current study suggest that there, perhaps, may be a disconnect in communication between investigators at South Carolina’s main academic medical centers and doctors practicing in other settings across the state. Effective communication strategies are key to breaking down this procedural barrier between CT researchers and local doctors, particularly those practicing in rural areas of the state. One of the most interesting findings focused on perceived barriers related to accrual of rural residents. Although African Americans are most often discussed in the literature as having numerous rates of health-related disparities and low rates of CT participation, results from this study show that it appears to be those in rural communities who are most often marginalized when it comes to CT recruitment and participation in the state of South Carolina.6 CT investigators indicated that it was most difficult to recruit from rural areas of the state, and that rural residents were least likely to be represented in their medical research, behind both the general public and African Americans. Furthermore, only about one third (36%) indicated that they make extra effort to accrue participants from these medically 6

The authors acknowledge that African American residents live in rural areas of the state, which could make it even more difficult to accrue these individuals for CTs.

93 underserved areas. These findings suggest CT investigators’ perceptions of South Carolina’s rural residents may be negatively influencing investigators’ efforts to educate and communicate with this underserved community. As Comis and colleagues (2003) explained, understanding the public’s attitudes toward CTs are an important first step toward recruiting participants into future CTs. Few investigators, however, truly understand their target population or recognize the importance of coalition building and networking that is critical when establishing trust in a community (Vesey, 2002). CT investigators’ perceptions may therefore impede effective recruitment among this large pool of potential CT participants in rural areas. Concurring with previous studies of barriers to recruitment in the African American community (Brown et al., 2000; Brown & Topcu, 2003; J. G. Ford et al., 2005; M. E. Ford et al., 2003; D. B. Friedman et al., 2009; Hudson et al., 2005; Lara et al., 2005; Moinpour et al., 2000), findings show that psychological barriers were significantly more likely to be perceived a problem in the African American communities than in both the general and rural population. Lack of knowledge and low literacy and health literacy were also perceived as significant barriers in African American and rural populations and could potentially contribute to the distrust and suspicion of CTs. Future studies should qualitatively examine how African Americans, as well as rural residents, perceive the concept of medical research, in an effort to determine how best to move forward with appropriate CT recruitment strategies. It is important to note that medical research abuse has occurred fairly recently in South Carolina, becoming national news in 2000 when the Supreme Court ruled in Ferguson v. City of Charleston that the Medical University of South Carolina’s policy regarding involuntary drug testing of pregnant women who were known crack users violated the Fourth Amendment. This case of medical abuse is still in the forefront of many South Carolina residents’ thoughts when it comes to the medical community as a whole. Perceived barriers and representation in CTs were largely the same across type of trial, funding source, and investigators’ years of experience. Two interesting findings did emerge, however, when examining type of funding and CT recruitment effort. Investigators conducting trials with federal funds were significantly more likely to make extra efforts to accrue CT participants from rural areas than those with private or institutional funding. Because of this extra effort, those with federally funded CTs were also more likely to believe that it is difficult or very difficult to recruit from rural areas. This finding could suggest that federally funded projects have more stringent recruiting requirements, thus mandating that investigators recruit a more diverse pool of participants. Future studies should examine the recruiting protocols of CTs state and nationwide and how they differ by funding source. Several factors limit the generalizability of our findings and should be noted. First, the participating principal investigators were recruited only from South Carolina’s five main, academic medical centers. This study did not include

94 principal investigators who may be conducting CTs in major medical centers across the United States or other medical settings in the state of South Carolina, although the authors are confident that this sample included the majority of principal investigators conducting CTs in South Carolina. Also, the focus on South Carolina’s main academic medical centers provided a relatively small pool of potential survey participants (N ¼ 382 after nonworking e-mails were purged from our list). Second, our response rate was 31%, a rate that some would suggest is somewhat low. A 30% response rate, however, is fairly typical, and in some instances high, for survey research with busy physicians and other health care professionals (Bonevski, Magin, Horton, Foster, & Girgis, 2011; Braithwaite, Emery, de Lusignan, & Sutton, 2003; Jepson et al., 2005; Kellerman & Herold, 2001; Knapp & Kirk, 2003). Last, our total number of responses per question on the principal investigator survey varied considerably since the survey was presented in an online format where participants could quit the survey at any time. As predicted, questions asked later in the survey had higher item-nonresponse rates (Couper, Traugott, & Lamias, 2001; Galesic & Bosnjak, 2009). Despite these limitations, study findings demonstrate that tailored communication and recruitment strategies are needed to better accrue CT participants in the state of South Carolina, especially in the 25 medically underserved counties where nearly 40% of the state’s population reside (State Rural Plan for South Carolina, 2008; U.S. Census Bureau, 2000; U.S. Office of Management and Budget, 2000). Future studies should explore how South Carolina residents living in rural and African American communities perceive the concept of medical research and assess the fit between CT recruiters’ perceptions about potential participants and the actual pool of participants. The current research, and proposed future areas of inquiry, could lead to enhanced CT communication strategies and increased awareness and knowledge of CT research and provide those in rural and African American communities the opportunity to obtain novel medical care close to home, and continue to reduce health disparities in the state of South Carolina.

Acknowledgments The authors are grateful to Dr. Jay Moskowitz (Health Sciences South Carolina) and Dr. Tom Guidice (South Carolina OB=GYN Associates) for their support and assistance.

Funding This work was supported by Health Sciences South Carolina.

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