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CTTI Project: Investigator Community
The Clinical Trials Transformation Initiative (CTTI) has announced recommendations to streamline Good Clinical Practice (GCP) training of investigators who participate in clinical trials.
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CTTI Project: Investigator Community
The Clinical Trials Transformation Initiative (CTTI) will unveil new recommendations aimed at reducing high rates of turnover among U.S. clinical trial site investigators at the Society for Clinical Research Sites (SCRS) Global Site Solutions Summit on Oct. 7. CTTI’s practical solutions address the administrative, financial, and logistical burdens that are causing investigators to abandon clinical research.
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APRIL 05, 2017
CTTI Project: Investigator Community
Meeting Objectives
Sheraton Silver Spring Hotel 8777 Georgia Ave., Silver Spring, MD
1. Issue, Project Overview, and Meeting Objectives by Diana Foster
2. One and Done Survey Design and Findings by Christopher Fordyce
3. Active Investigator Interview Findings by Terri Hinkley Key
4. Elements for Site Investigator Success by Matthew Roe
5. Fiscal Responsibility and Discipline by Kaitlin Malone
6. Optimizing Trial Execution and Conduct by Robin Douglas
7. Investigator Perspective: My Approach / Why Do I Remain Involved? by David Whellan
8. PCORnet by Matthew Roe
9. A Primer in FDA Resources for Clinical Investigators by Bridget Foltz
10. FDA Observations Related to Investigator Participation by David Burrow
The views and opinions expressed in this presentation are those of the individual presenter and should not be attributed to the Clinical Trials Transformation Initiative, or any organization with which the presenter is employed or affiliated.
CTTI Project: Investigator Community
Presenters:
*CTTI encourages the use of all materials listed on this site in the pursuit of improving the clinical trials enterprise. If you use any of the slides from this presentation, please let us know, credit CTTI, and make it clear that you are not presenting on behalf of CTTI.
Building on a previous study on the reasons why principal investigators conduct only one FDA-regulated drug trial (“one-and-done” investigators), a new CTTI article published in Contemporary Clinical Trials Communications explores the converse: barriers and critical factors that contribute to “active” investigators’ success while conducting multiple trials.
Through in-depth interviews with 23 experienced investigators, CTTI found that “active” investigators cited infrastructure, staff support, advance planning, and personal qualities as critical factors in successfully conducting multiple trials. They also shared many of the same barriers and frustrations that “one-and-done” investigators faced—including trial finances and patient recruitment—however, “active” investigators had developed strategies to overcome these barriers. Of particular importance, the amount and type of support to which investigators have access may represent a crucial difference between “active” and “one-and-done.”
The study resulted from CTTI’s investigator community work, which explored factors that influence investigators’ decisions to leave or remain in clinical research practice. Through this research and multi-stakeholder engagement, CTTI created a set of recommendations that systematically address barriers and implement reliable solutions to help reduce attrition of first-time and veteran investigators who leave the research environment.
Why are turnover rates so high for site investigators? What can be done to strengthen the investigator community? CTTI’s exploration of this question and resulting recommendations were published this week in the peer-reviewed journal Contemporary Clinical Trials Communications.
CTTI’s work on improving the Investigator Community aimed to better understand why some clinical investigators remain actively engaged in clinical research but others decide to leave it after a single experience. Evidence suggests that many investigators are leaving clinical research due to burdens imposed by trial-related responsibilities—a trend that could hinder the quality and efficiency of clinical trials.
CTTI’s evidence-based recommendations address the challenges faced by site investigators and offer solutions for improving their experience. The recommendations focus on streamlining research infrastructure and staff, clarifying site budget and contract negotiations, optimizing trial execution and conduct, and providing opportunities to conduct additional trials. CROs, sponsors, health systems, investigators, and others can use CTTI’s work to create a research environment that sustains long-term engagement, and fosters improved quality and efficiency in clinical trials.
