CTTI Challenges Current Investigator Training Regimen

Jennifer Goldsack, MChem, MA, MBA, CPHQ, Project Manager, Clinical Trials Transformation Initiative

Jennifer Goldsack, MChem, MA, MBA, CPHQ, Project Manager, Clinical Trials Transformation Initiative

Good clinical practice (GCP) training has become the standard for qualifying investigators to conduct clinical trials, but little evidence has been collected to determine whether this training is providing the necessary knowledge and skills, says Jennifer Goldsack, MA, MBA, CPHQ, project manager of a team conducting in-depth interviews of contract research organizations (CROs), sponsors, and investigators.

Rather than accepting GCP training as the default solution for qualifying investigators, the Clinical Trials Transformation Initiative (CTTI) has launched a project on “Qualifying Investigators to Conduct Sponsored Clinical Trials.” Project leaders hope to gain a broader, evidence-based perspective that can inform the efficient and effective qualification of site investigators to advance the high-quality conduct of clinical trials.

CTTI hopes its findings will be “disruptive,” Goldsack says. To achieve it, CTTI’s commitment to evidence-based recommendations will be key. The project team working on this effort already boasts a diverse, multistakeholder group of experts. They are insistent on digging deeper, though, conducting expert interviews with dozens of investigators and sponsor experts, and planning for a large, expert meeting in the fall.

“We didn’t want a ‘check the box’ kind of survey,” Goldsack explains. “We want to get to the heart of [the issue] and come up with ways to fix it.”

While full recommendations aren’t likely to be published until Spring 2018, CTTI hopes to have some preliminary results in the next few months. Interviews are already under way, with early indications suggesting that this will be a highly effective approach to identifying training problems.

Other team members include ACRP Workforce Innovation Officer Terri Hinkley, RN, BScN, MBA, CCRC, FACRP. According to Hinkley, “As investigative products become more complex and are intended to treat more complex diseases, our trials have naturally become more difficult and require much more expertise in clinical trial conduct to successfully complete them. With this project, we hope to determine what the key training requirements are for investigators and their staff.”

CTTI invites investigators of phase III clinical trials to participate in an interview to share your perspectives on training for clinical trial investigators and their delegates on the quality conduct of sponsored clinical trials. Those who meet the eligibility criteria and are interested in participating will participate in a 1-hour telephone interview. Participants will be compensated for the interview.  Participation is voluntary. There are no direct benefits from participating. Anything investigators say during the interview will be kept confidential. Names will not be included in any reports, articles, or presentations about this study.

For more information about the project or if you are interested in participating in an interview, contact Goldsack at +1.919.358.0383 or jennifer.goldsack@duke.edu.

Author: Michael Causey


Related — GCP for the Experienced Investigator: Reducing Risks and Avoiding Common Inspection Findings

Learn about today’s most common inspection findings and proven strategies to avoid them through correct application of GCP guidelines in this eLearning course from ACRP. Avoid site-related findings by obtaining an in-depth understanding of how to ensure compliance. Take your knowledge and application of ICH E6 Good Clinical Practice to the next level and fulfill your responsibilities as an investigator to reduce the risk of inspection findings and attracting more clinical trials to your research site.

Learn More