**Acknowledgements**

The results of supplemental analyses demonstrate that there are statistically significant relationships between all but one of the subscales of the instrument (including all of the verbal communication measures) and years of experience. This may indicate that as research professionals gain experience, they acquire knowledge about effective strategies to communicate about complex medical and scientific concepts. In fact, the fact that the measure of nonverbal communication (behaviors which are often described as something akin to "instinctual" or innate in the published studies of Morgan and colleagues) has a correlation of nearly zero may indicate that many individuals who are drawn to this type of research position may naturally be "people-people" who may nonetheless benefit from training programs with an emphasis on verbal communication techniques when recruiting and consenting potential research participants. Tentative validity testing of several items and subscales of the instrument described here was performed in early 2017. The results of this early pilot testing demonstrated that items contained in the Clinical Trial Communication Inventory can be used to assess the pre- to post-test impact of a clinical trial communication training (see Ref. [17] for

While the CTCI is likely to prove useful to evaluate efforts in clinical trial communication training, it should be noted that with a relatively small sample, the validity of factor analytic strategies used to construct some of the initial scales may be limited, although the scales we created based on these results showed strong reliability. Future research should further develop this instrument by testing its robustness with a larger sample of research coordinators and validate it with other types of medical professionals who recruit for clinical trials, including physicians and study nurses. Additionally, it is vitally important for this instrument to be evaluated through convergent validity testing. The question remains whether the Clinical Trial Communication Inventory reflects real-world communication practice and indeed, whether these communication behaviors predict increased informed decision making or improved rates of clinical trial accrual. Convergent validity can be established through a variety of strategies, including checklists of exhibited communication behaviors during role plays and video recordings of actual recruitment and consent behaviors with patients. Predictive validity could be established by demonstrating that communication training results in changed scores on the CTCI from pre- to post-test, and more importantly, that scores post-training reflect improvements to informed consent with patients, which can be evaluated through patient "teach-backs" and an increased number of accurate responses to a

Improvement of low accrual to clinical trials and research studies is urgently needed, particularly for members of minority populations. Research has demonstrated that communication behaviors play an important role in the recruitment and consent processes. While communication behaviors can (and should) be developed through professional seminars and workshops, there are few available instruments to conduct evaluations of the outcomes of those trainings. In this chapter, we outline the development and testing of a measure of communication in clinical trial contexts: the Clinical Trial Communication Inventory. While additional

full results of the evaluation).

208 Clinical Trials in Vulnerable Populations

set of study-related knowledge questions.

**5. Conclusion**

The authors wish to thank the participants who completed the survey. A special thank goes to Patricia Avissar and Robert Kolb for their help with the recruitment process.
