**2. Methods**

measures, treatments, screenings, and diagnostic techniques [3]. However, despite the evi‐ dence for the positive benefits of conducting clinical trials, and despite the overall agreement on the importance of clinical research (as evidenced by the Cancer Moonshot initiative and recent, highly funded efforts directed toward advancing precision medicine), researchers are limited by the low number of patients consenting to join clinical research studies [4, 5]. The most critical consequence of low accrual rates is that treatment effectiveness cannot be ade‐ quately assessed, even if a new regimen appears to be promising [6]. Research on the reasons for clinical trials' low accrual rates has identified several key barriers, which include a low rate of physicians' referral [7, 8]. Many physicians characterize discussions about research and clinical trials with patients as particularly challenging, a problem, which is rarely addressed,

Physicians are not the only professionals who face challenges when trying to communicate about clinical trials. In fact, clinical and medical research teams are typically composed of a heterogeneous group of professionals with specific skills and roles; these include study nurses, clinical research coordinators, research associates, nonstudy personnel, and professional recruiters [9]. Regardless of the role, however, good communication skills are necessary to meet the needs of both patients and PIs to ensure both information comprehension and accrual [10, 11]. Conversations with patients and their families intended to educate them about partici‐ pation in clinical trials and research studies present unique challenges that differ significantly from typical exchanges in the provider‐patient encounter. Discussions about clinical trial par‐ ticipation are quite challenging due to the uncertainty regarding the outcomes of clinical trials, and the complex nature of consent documents [12]. For example, a treatment recommendation that involves the possibility of enrolling in a clinical trial is fraught with uncertainty because patients are generally randomized into one of multiple treatment arms, and because the treat‐ ment itself is under study [13]. Thus, both the treatment outcomes and any possible side effects have yet to be defined. Additionally, recruiters (whether clinical research professionals, physi‐ cians, or study nurses) need to provide information through documents that are strictly gov‐ erned by legal and ethical policies. The content and the structure of the consenting documents are complex and often difficult to understand for patients [14]. Many patients express concerns about the trustworthiness of the clinical research process and the experts involved [14, 15].

Because of the uncertainty associated with the treatment, the complexity of procedures and docu‐ ments, the vulnerability of patients, and the often‐negative attitudes of patients toward medical research, discussions about clinical trial participation can be difficult for both patients as well as clinical personnel. Because patients' intentions to enroll into a clinical trial are strongly related to the competency of communication by recruiters [16, 17], and because communication is a mediat‐ ing variable in the decision process on whether or not enroll [14, 15, 18], it is essential for medical and clinical research professionals receive training on how to better communicate with patients about participating in clinical trials and research studies. Trainings specifically aimed at improv‐ ing communication skills may help to increase the rate of patient accrual to clinical trials [10, 19]. Although there have been successful training programs focused on doctor‐patient communica‐ tion [20–25], there is little theoretical and empirical research on the best way to develop trainings for improving clinical trial communication. Previous studies of other types of communication training programs in health care environments have provided evidence that the structure of the training as well as the type of educational materials employed have dramatic consequences on

even by academic medical centers committed to the research enterprise [9].

178 Clinical Trials in Vulnerable Populations

#### **2.1. Key terms and databases**

A literature review was performed by using several databases, namely scholar.google.com, university library's database, MEDLINE, PsycINFO. The search terms used were "clinical tri‐ als training," "clinical trials recruiters training," "cancer trials training," "clinical trials recruit‐ ers' communication," and "clinical trials patients' recruitment." Second, an additional search was conducted by checking the references employed by the articles considered relevant for the purposes of the present study. This process yielded 22 articles on communication training programs designed to increase medical and nonmedical professionals' efficacy in recruiting potential participants for research studies and clinical trials.

#### **2.2. Inclusion and exclusion criteria**

In order to be included in this systematic review, the studies had to meet several criteria. First, they had to deliver and test educational trainings; second, participants in the trainings had to be health care professionals; third, the trainings had to provide instructions and edu‐ cational materials or activities to improve clinical trial communication skills. After a careful review of the literature, 22 studies were found to be appropriate for the present systematic review. Further, in order to be considered in this systematic review, the studies had to meet the following inclusionary criteria: report on physicians' and medical personnel communica‐ tion strategies to recruit patients; provide empirical evidence rather than theoretical asser‐ tions or recommendations (that is, qualitative or quantitative data had to be reported), and results had to be published in a peer‐review journal.

#### **2.3. Data extraction and analysis**

Information from the studies selected for this project was summarized into tables and com‐ pared across studies. Key information that was retrieved included authors' names, year of publication, country where the trainings were conducted, journal in which the findings were published, theoretical background, methods adopted for the study, type of training, demo‐ graphics, content development methodology, format of educational material, timing of the program, and learning assessment.
