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. 2015 Oct 14;10(10):e0140232.
doi: 10.1371/journal.pone.0140232. eCollection 2015.

Patient Engagement Practices in Clinical Research among Patient Groups, Industry, and Academia in the United States: A Survey

Sophia K Smith  1 , Wendy Selig  2 , Matthew Harker  3 , Jamie N Roberts  3 , Sharon Hesterlee  4 , David Leventhal  5 , Richard Klein  6 , Bray Patrick-Lake  3 , Amy P Abernethy  7
Affiliations

Patient Engagement Practices in Clinical Research among Patient Groups, Industry, and Academia in the United States: A Survey

Sophia K Smith et al. PLoS One. .

Abstract

Objective: Patient-centered clinical trial design and execution is becoming increasingly important. No best 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 practices for 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 mailing lists. 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 contributions were valued by industry and academic respondents (all p < .001). Patient group respondents placed higher value in open communications, clear expectations, and detailed contract execution than did non-patient group respondents (all p < .05). Industry and academic respondents more often cited internal bureaucratic processes and reluctance to share 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 of collaboration 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 stakeholder groups, key differences exist in perceived barriers and benefits to partnering with patient groups among the sectors studied. This recognition could inform the development of best practices for patient-centered clinical trial design and execution. Additional research is needed to define and optimize key success factors.

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Conflict of interest statement

Competing Interests: Financial activities outside the submitted work include (1) Until 3/31/2015, WS was president and CEO of Melanoma Research Alliance and is presently founder and CEO of WS Collaborative LLC; (2) SH serves on the Board of Directors of the Health Research Alliance, a professional organization representing over 60 nonprofit patient organizations and health funding foundations, and has received funding to attend conferences conducted by Parent Project Muscular Dystrophy (PPMD) from PTC Therapeutics, Sarepta Therapeutics, Pfizer, Lilly, Shire, Prosensa, Catabasis, Tivorsan, Summit PLC, and Halo Therapeutics; (3) DL is the director of clinical innovation at Pfizer Worldwide Research and Development, (4) APA is chief medical officer and senior vice president of oncology at Flatiron Health Inc. This does not alter the authors' adherence to PLOS ONE policies on sharing data and materials. The other authors have no disclosures related to financial or nonfinancial activities.

References

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