Patient engagement practices in clinical research among patient groups, industry, and academia in the United States: A survey

Abstract

Objective: Patient-centered clinical trial design and execution is becoming increasingly important. Nobest practice guidelines exist despite a key stakeholder declaration to create more effective engagement models. This study aims to gain a better understanding of attitudes and practicesfor engaging patient groups so that actionable recommendations may be developed. Methods: Individuals from industry, academic institutions, and patient groups were identified through Clinical Trials Transformation Initiative and Drug Information Association rosters and mailinglists. Objectives, practices, and perceived barriers related to engaging patient groups in the planning, conduct, and interpretation of clinical trials were reported in an online survey. Descriptive and inferential statistical analysis of survey data followed a literature review to inform survey questions. Results: Survey respondents (n = 179) valued the importance of involving patient groups in research; however, patient group respondents valued their contributions to research protocol development, funding acquisition, and interpretation of study results more highly than those contributionswere valued by industry and academic respondents (all p < .001). Patient group respondents placed higher value in open communications, clear expectations, and detailedcontract execution than did non-patient group respondents (all p < .05). Industry and academic respondents more often cited internal bureaucratic processes and reluctance toshare information as engagement barriers than did patient group respondents (all p < .01). Patient groups reported that a lack of transparency and understanding of the benefits ofcollaboration on the part of industry and academia were greater barriers than did non- patient group respondents (all p< .01). Conclusions: Despite reported similarities among approaches to engagement by the three stakeholdergroups, key differences exist in perceived barriers and benefits to partnering with patient groups among the sectors studied. This recognition could inform the development of bestpractices for patient-centered clinical trial design and execution. Additional research is needed to define and optimize key success factors.