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The Rules of Engagement: CTTI Recommendations for Successful Collaborations Between Sponsors and Patient Groups Around Clinical Trials
- Source :
- Therapeutic Innovation & Regulatory Science
- Publication Year :
- 2018
- Publisher :
- Springer Science and Business Media LLC, 2018.
-
Abstract
- Objective: To identify the elements necessary for successful collaboration between patient groups and academic and industry sponsors of clinical trials, in order to develop recommendations for best practices for effective patient group engagement. Methods: In-depth interviews, informed by a previously reported survey, were conducted to identify the fundamentals of successful patient group engagement. Thirty-two respondents from 3 sectors participated: patient groups, academic researchers, and industry. The findings were presented to a multistakeholder group of experts in January 2015. The expert group came to consensus on a set of actionable recommendations for best practices for patient groups and research sponsors. Results: Interview respondents acknowledged that not all patient groups are created equal in terms of what they can contribute to a clinical trial. The most important elements for effective patient group engagement include establishing meaningful partnerships, demonstrating mutual benefits, and collaborating as partners from the planning stage forward. Although there is a growing appreciation by sponsors about the benefits of patient group engagement, there remains some resistance and some uncertainty about how best to engage. Barriers include mismatched expectations and a perception that patient groups lack scientific sophistication and that “wishful thinking” may cloud their recommendations. Conclusions: Patient groups are developing diverse skillsets and acquiring assets to leverage in order to become collaborators with industry and academia on clinical trials. Growing numbers of research sponsors across the clinical trials enterprise are recognizing the benefits of continuous and meaningful patient group engagement, but there are still mindsets to change, and stakeholders need further guidance on operationalizing a new model of clinical trial conduct.
- Subjects :
- medicine.medical_specialty
Biomedical Research
Drug Industry
Universities
Best practice
Alternative medicine
Pharmacy
therapeutic development
Public-Private Sector Partnerships
01 natural sciences
Rules of engagement
010104 statistics & probability
03 medical and health sciences
0302 clinical medicine
medicine
Humans
best practices
Clinical Trials
Pharmacology (medical)
030212 general & internal medicine
Cooperative Behavior
0101 mathematics
Pharmacology, Toxicology and Pharmaceutics (miscellaneous)
Clinical Trials as Topic
Medical education
United States Food and Drug Administration
business.industry
Public Health, Environmental and Occupational Health
actionable recommendations
Public relations
Research Personnel
United States
Clinical trial
patient group engagement
Patient Participation
business
Psychology
Subjects
Details
- ISSN :
- 21684804 and 21684790
- Volume :
- 52
- Database :
- OpenAIRE
- Journal :
- Therapeutic Innovation & Regulatory Science
- Accession number :
- edsair.doi.dedup.....41d077431f697f71cd8110386c2887e9