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. 2019 Oct 17:16:100462.
doi: 10.1016/j.conctc.2019.100462. eCollection 2019 Dec.

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

Christopher B Fordyce  1   2 , Kaitlin Malone  3 , Annemarie Forrest  4 , Terri Hinkley  5 , Amy Corneli  1   4   6 , James Topping  1 , Matthew T Roe  1
Affiliations

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

Christopher B Fordyce et al. Contemp Clin Trials Commun. .

Abstract

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.

Keywords: BMIS, Bioresearch Monitoring Information System; CRO, contract research organization; CTTI, Clinical Trials Transformation Initiative; Clinical trials; FDA, Food and Drug Administration; Investigator retention; Investigator turnover; PI, Principal Investigator; Research infrastructure; SOP, standard operating procedure; US, United States.

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Figures

Fig. 1
Fig. 1
Survey results: Reasons “one and done” investigators No longer conduct FDA-Regulated drug trials.
Fig. 2
Fig. 2
CTTI recommendations snapshot.
See this image and copyright information in PMC

References

    1. Applied Clinical Trials Editors Sustaining the investigator pool: Understanding operational burden and implementing valuable supportive solutions. 2014. http://www.appliedclinicaltrialsonline.com/sustaining-investigator-pool-... Accessed March 07 2019.
    1. Fordyce C., Roe M.T., Pierre C., Hinkley T., Hamre G., Tenaerts P., McCall J., Topping J. Trends in clinical trial investigator workforce and turnover: an analysis of the US FDA 1572 BMIS database. J. for the Society of Clin. Trials. 2019 May 21;15 - PMC - PubMed
    1. Corneli A., Pierre C., Hinkley T., Lin L., Fordyce C.B., Hamre G., Roe M.T. One and done: reasons principal investigators conduct only one FDA-regulated drug trial. Contemp Clin Trials Commun. 2017;6:31–38. - PMC - PubMed
    1. Clinical Trials Transformation Initiative Expert meeting: strengthening the investigator community project. 2017. https://www.ctti-clinicaltrials.org/briefing-room/meetings/strengthening... Accessed March 07 2019.
    1. Clinical Trials Transformation Initiative Steering committee. https://www.ctti-clinicaltrials.org/who-we-are/organizational-structure/... Accessed March 07 2019.