Investigators

CTTI Launches New Project to Improve Process for Qualifying Investigators to Conduct Clinical Trials

Posted on by Lorri Bingham

Ineffective or redundant training for investigators wastes time, resources, and does not prepare investigators for the quality conduct of clinical trials. Rather than accepting GCP training as the default solution for qualifying investigators to conduct clinical trials, CTTI is collecting evidence to determine effective and efficient approaches.

While good clinical practice (GCP) training has become the standard for qualifying investigators to conduct clinical trials, little evidence has been collected to determine whether this training is providing the necessary knowledge and skills. CTTI’s new Investigator Qualification Project will evaluate current approaches to investigator qualification, including GCP training, and issue recommendations on effective and efficient methods for investigators to become qualifiehttps://ctti-clinicaltrials.org/projects/investigator-qualification-gcp-trainingd to conduct clinical trials. Investigators, research sponsors, and trial participants are all expected to benefit from an improved investigator qualification process.

CTTI previously released recommendations to address the issue of staff being required to take GCP training before each clinical trial, often multiple times each year. The Investigator Qualification Project is an extension of this work and will focus on the quality of training. CTTI will gather evidence to identify gaps and redundancies in current training, as well as suggest other ways of ensuring that investigators are qualified for the quality conduct of clinical trials.

CTTI Examines Investigator Turnover in New Paper

Posted on by Lorri Bingham

Learn About Issues Affecting the Supply of Experienced and Engaged Trial Investigators

Clinical trials work best when experienced investigators conduct research activities. But chronically high rates of investigator turnover mean that a substantial proportion of FDA-regulated drug trials are led by clinicians who step forward to conduct a trial, but then do not go on to conduct other trials—so-called “one and done” investigators. This has serious implications, because investigator turnover is associated with higher costs and greater levels of inefficiency for clinical trials.

To get a clearer picture of what factors are driving this turnover and how it affects the investigator community, CTTI researchers surveyed clinicians about factors affecting their decisions to conduct only one FDA-regulated drug trial. Using the federal Bioresearch Monitoring Information System (BMIS), which contains data on physicians who have submitted forms required for participation in FDA-regulated trials (the “Form FDA 1572”), they identified investigators who had conducted only one FDA-regulated trial (including trials that were still ongoing) at the time of the survey. They were particularly interested in learning what kinds of barriers to continued participation these investigators were encountering and which ones had the most impact on their decision to conduct only one FDA-regulated drug trial.

Figure 1The CTTI group’s findings, which have been published in the journal Contemporary Clinical Trials Communications, show that a little over half of the roughly 200 investigators who participated in the survey did not plan to take part in any further FDA-regulated drug trials. Among this group, the reasons given for not wishing to participate further in such trials differed substantially according to whether the survey participants were academic or non-academic/community-based clinicians. More “one and done” academic investigators indicated they were no longer participating because of a lack of available trials, while “one and done” community investigators were more likely to cite personal choice as the reason for not participating.

Although the investigators surveyed acknowledged a wide variety of barriers to participating in FDA-regulated drug trials, several broad categories were identified across most investigators:

  • Time requirements and difficulty in balancing workloads
  • Burdens imposed by data and safety reporting
  • Problems with different aspects of trial finances

The survey results revealed high rates of investigator turnover for FDA-regulated drug trials among the study participants; they also provide details and insights into the reasons that site investigators stop conducting such studies. This study was done as part of a larger CTTI project that focuses on strengthening the community of clinical investigators. Work is now underway on extending the findings from this preliminary survey to create a better understanding of the factors that influence clinicians’ decisions to participate as investigators in multiple FDA-regulated drug trials.

Learn more about CTTI’s Strengthening the Investigator Site Community Project.

CTTI Insights for Research Sites Featured at Upcoming SCRS Summit

Posted on by Lorri Bingham

SCRS Global Site Solutions SummitCTTI’s work will be featured in two presentations at the upcoming Society for Clinical Research Sites (SCRS) Global Site Solutions Summit on October 13-16, a conference aimed at fostering collaboration between industry and sites in clinical research.

CTTI Executive Director Pamela Tenaerts will be sharing insights on initiatives to assist sites as key stakeholders in studies and to improve overall collaboration in clinical research. Tenaerts will reinforce CTTI’s commitment to help sites be successful.

SCRS President Christine Pierre will present CTTI’s research on investigator turnover and its impact on-site resources and overall trial performance. Investigator turnover is a major inhibitor of site efficiency in trials, and Pierre will share ideas for better supporting sites in order to increase PI retention.

CTTI is proud to participate in this conference aimed at building strong partnerships between stakeholders.

 

SCRS 2016 Global Site Solutions Summit
Conference Location: Boca Raton, Florida

Presentation Topic: Investigator Turnover
Speaker: Christine Pierre
Date & Time: October 14, 2016, at 4:10 p.m. ET

Presentation Topic: Sites Matter: Industry Collaboration
Speaker: Pamela Tenaerts
Date & Time: October 14, 2016, at 5:30 p.m. ET

 

 

New Publication Points to Solutions to Reduce Unnecessary Burden on Clinical Trial Sites

Posted on by Lorri Bingham

Time and energy are valuable resources to clinical investigators. CTTI’s recent publication, “Good Clinical Practice Training: Identifying Key Elements and Strategies for Increasing Training Efficiency,” provides evidence that redundant Good Clinical Practice (GCP) training places an unnecessary burden on investigators. Investigators should be relieved of the burden of repetitive training so they can focus on what matters most: protecting the rights, integrity, and confidentiality of clinical trial participants and assuring the credibility and accuracy of data and reported results. The authors offer suggestions to increase applied learning, focus on relevant trial information, and tailor training for specific job functions.

CTTI’s GCP Training Project team conducted a literature review to inform the project on current practices in the implementation of GCP training and analyzed sample GCP training programs. The findings were discussed by a multi-stakeholder group of experts who helped the team to develop official recommendations that were released in 2015. The recommendations include the 13 minimum essential elements for a training program, training frequency and format, and evidence of successful completion of training.

The paper was published in Therapeutic Innovation & Regulatory Science (TIRS).

CTTI Recommendations for Improving GCP Training to be Unveiled

Posted on by Lorri Bingham

CTTI’s GCP Training Project set out to develop recommendations for streamlining GCP training practices. After assessing data on current training programs and gaining consensus around strategies to reduce the burden of redundant training, CTTI’s multi-stakeholder working group has developed recommendations on the content and frequency for GCP training.

The final results and recommendations of this project will be unveiled on January 29, 2015 in a public webinar hosted by the Society for Clinical Research Sites (SCRS). We invite our colleagues in the clinical trials enterprise to attend this exciting event and we encourage the sharing of this invitation.

Additional information on this webinar is listed below:

Webinar: A New View: How Frequently is GCP Training Needed and What Should Be Included?

Panelists:

  • Bridget Foltz, MS, MT (ASCP) | U.S. Food and Drug Administration
  • Michael Koren, MD, FACC, CPI | Jacksonville Center for Clinical Research
  • Jonathan Seltzer, MD, MBA, MA, FACC | ACI Clinical
  • Gretchen Wild, MBA, MHA | St. Jude Medical

Date: January 29, 2015 at 12:00 PM EST

Cost: Free

Registration: Click here to register. (After registration, you will be emailed the login details.)

Results of CTTI’s GCP Training Project Featured at NCATS Meeting

Posted on by Lorri Bingham

The first of two working meetings for the Enhancing Clinical Research Professionals’ Training and Qualifications project took place earlier this week in Chicago, IL. At this national conference, CTTI’s Executive Director Pamela Tenaerts presented CTTI Findings and Recommendations for GCP Training, based on our GCP Training Project.

The primary goal of this first meeting [was] to achieve consensus in identifying a standardized training platform in Good Clinical Practice (GCP) and the necessary means to disseminate it across all consortium sites. (ctsacentral.org)

The Enhancing Clinical Research Professionals’ Training and Qualifications project is supported by a National Center for Advancing Translational Sciences (NCATS) supplement award and serves the Clinical and Translational Science Award (CTSA) consortium.