title: 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. 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.
authors.affiliation: School of Nursing, Duke University, Durham, NC, United States of America.
authors.forename: Sophia K
authors.initials: SK
authors.lastname: Smith
authors.affiliation: WS Collaborative, McLean, VA, United States of America.
authors.forename: Wendy
authors.initials: W
authors.lastname: Selig
authors.affiliation: Clinical Trials Transformation Initiative, Duke Clinical Research Institute, Durham, NC, United States of America.
authors.forename: Matthew
authors.initials: M
authors.lastname: Harker
authors.affiliation: Clinical Trials Transformation Initiative, Duke Clinical Research Institute, Durham, NC, United States of America.
authors.forename: Jamie N
authors.initials: JN
authors.lastname: Roberts
authors.affiliation: Parent Project Muscular Dystrophy, Hackensack, NJ, United States of America.
authors.forename: Sharon
authors.initials: S
authors.lastname: Hesterlee
authors.affiliation: Pfizer Worldwide Research and Development, Groton, CT, United States of America.
authors.forename: David
authors.initials: D
authors.lastname: Leventhal
authors.affiliation: U.S. Food and Drug Administration, Silver Spring, MD, United States of America.
authors.forename: Richard
authors.initials: R
authors.lastname: Klein
authors.affiliation: Clinical Trials Transformation Initiative, Duke Clinical Research Institute, Durham, NC, United States of America.
authors.forename: Bray
authors.initials: B
authors.lastname: Patrick-Lake
authors.affiliation: Flatiron Health, New York, NY, United States of America.
authors.forename: Amy P
authors.initials: AP
authors.lastname: Abernethy
mesh_terms: D035843:Biomedical Research; D002986:Clinical Trials as Topic; D003299:Cooperative Behavior; D006801:Humans; D007221:Industry; D010358:Patient Participation; D011795:Surveys and Questionnaires; D014481:United States