Primary care perspectives on implementation of clinical trial recruitment

J Clin Transl Sci. 2019 Dec 26;4(1):61-68. doi: 10.1017/cts.2019.435. eCollection 2020 Feb.

Abstract

Introduction: Poor clinical trial (CT) recruitment is a significant barrier to translating basic science discoveries into medical practice. Improving support for primary care provider (PCP) referral of patients to CTs may be an important part of the solution. However, implementing CT referral support in primary care is not only technically challenging, but also presents challenges at the person and organization levels.

Methods: The objectives of this study were (1) to characterize provider and clinical supervisor attitudes and perceptions regarding CT research, recruitment, and referrals in primary care and (2) to identify perceived workflow strategies and facilitators relevant to designing a technology-supported primary care CT referral program. Focus groups were conducted with PCPs, directors, and supervisors.

Results: Analysis indicated widespread support for the intrinsic scientific value of CTs, while at the same time deep concerns regarding protecting patient well-being, perceived loss of control when patients participate in trials, concern about the impact of point-of-care referrals on clinic workflow, the need for standard processes, and the need for CT information that enables referring providers to quickly confirm that the burdens are justified by the benefits at both patient and provider levels. PCP suggestions pertinent to implementing a CT referral decision support system are reported.

Conclusion: The results from this work contribute to developing an implementation approach to support increased referral of patients to CTs.

Keywords: FHIR; Primary care; clinical trial recruitment; implementation; system design.