Patient Engagement at a Tipping Point—The Need for Cultural Change Across Patient, Sponsor, and Regulator Stakeholders: Insights From the DIA Conference, “Patient Engagement in Benefit Risk Assessment Throughout the Life Cycle of Medical Products”

Author:

Smith Meredith Y.,Hammad Tarek A.,Metcalf Marilyn,Levitan Bennett,Noel Rebecca,Wolka Anne M.,Michaels Debra L.,Johnson F. Reed

Publisher

Springer Science and Business Media LLC

Subject

Pharmacology (medical),Public Health, Environmental and Occupational Health,Pharmacology, Toxicology and Pharmaceutics (miscellaneous)

Reference34 articles.

1. Patient-Centered Outcomes Research Institute (PCORI). PCORI engagement rubric. http://www.pcori.org/sites/default/files/Engagement-Rubric.pdf. Published February 4, 2014. Accessed May 28, 2016.

2. Clinical Trials Transformation Initiative. Best practices for effective engagement with patient groups around clinical trials. http://www.ctti-clinicaltrials.org/what-we-do/investigational-plan/patient-groups. Accessed May 28, 2016.

3. Smith SK, Selig W, Harker M, et al. Patient engagement practices in clinical research among patient groups, industry, and academia in the United States: a survey. PLoS One. 2015;10:e0140232.

4. National Institutes of Health (NIH) Clinical and Translational Science Awards Consortium—Community Engagement Key Function Committee Task Force on the Principles of Community Engagement. Principles of Community Engagement. 2nd ed. http://www.atsdr.cdc.gov/communityengagement/pdf/PCE_Report_508_FINAL.pdf. Published June 2011. Accessed May 28, 2016.

5. Institute of Medicine (IOM). Crossing the Quality Chasm: A New Health System for the 21st Century. Washington, DC: National Academy Press; 2001.

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