Improving and sustaining the site investigator community: Recommendations from the Clinical Trials Transformation Initiative.

Published online

Journal Article

The Clinical Trials Transformation Initiative (CTTI) Strengthening the Investigator Community Project was prompted by the need to understand the reasons for high rates of turnover among investigators who lead US Food and Administration-regulated clinical trials at research sites. Because investigator knowledge and experience directly affect the quality and ultimate success of clinical trials, investigator turnover has important implications for the research enterprise, as well as the patients and other stakeholders who depend on the outcomes of clinical research. The CTTI project team used findings from both quantitative and qualitative research activities, as well as input from an expert meeting with multiple stakeholders, to delineate key concerns faced by investigators and recommend practical, action-based solutions. The recommendations focus on strengthening four key categories of site-based research activity: developing site-based research infrastructure and staff, optimizing trial execution and conduct, improving site budget development and contract negotiations, and discovering opportunities for conducting additional trials.

Full Text

Duke Authors

Cited Authors

  • Fordyce, CB; Malone, K; Forrest, A; Hinkley, T; Corneli, A; Topping, J; Roe, MT

Published Date

  • December 2019

Published In

Volume / Issue

  • 16 /

Start / End Page

  • 100462 -

PubMed ID

  • 31701037

Pubmed Central ID

  • 31701037

Electronic International Standard Serial Number (EISSN)

  • 2451-8654

Digital Object Identifier (DOI)

  • 10.1016/j.conctc.2019.100462


  • eng

Conference Location

  • Netherlands