Clinical Trial Sponsors, Investigators Debate Improvements in GCP Training
Sponsors and investigators agree on what GCP training should cover but vary in their opinions on how the delivery of that training can be improved, according to a new paper from Clinical Trials Transformation Initiative (CTTI).
While the 13 investigators and 10 sponsors interviewed for the paper cited the same three priority topics — informed consent, protocol compliance and trial participant’s health and safety — for training, they differ in how best to craft those priorities in terms of GCP training frequency, conduct and methods, standardization, and content.
The most common challenges both groups cited was too-frequent training and repetitive content. The investigators want better strategies for easing the GCP training burden and decreasing the frequency of training. Investigators also feel that adverse events, data quality/integrity, forms/processes/labs and informed consent GCP training modules tend to be repetitive and time-consuming.
“I want less GCP training. It’s gotten so burdensome. I’m just one person, and if you have 40 staff at a site, so you have all that redundancy with 40 people, each one on 5 trials, except for me, I’m on all of them,” said one investigator.
Sponsors, however, agree that some of the repetition is necessary. As one sponsor noted, “Sometimes there’s good in being redundant, particularly when we talk about protecting patients. I think when there is redundancy, it is appropriate. I wouldn’t say that there’s something on here that doesn’t prepare physicians for conducting clinical studies.
Investigators recommend creating universally recognized GCP training standards that all sponsors would accept as valid. Sponsors suggest establishing an industrywide agreement on a core set of training standards and materials to ensure that all investigators are starting the training with the same basic framework and to reduce differences in GCP understanding caused by multiple independent training programs.
To improve GCP training, investigators want better strategies for easing the GCP training burden, decreasing the frequency of training and inciting interest in the training topics, whereas sponsors want better applications for sparking GCP trainees’ interest and directing their attention to the most relevant material. Both agree on the need to move beyond GCP training as “just another box to check” by making it more engaging and interactive and both suggest utilizing more interactive and skills-based applications so the training will be more participatory and effective.
“It’s time to move away from just checking the box of completing GCP online training,” says Christina Brennan, vice president of clinical research at the Feinstein Institutes for Medical Research, Northwell Health and an author of the paper. “This is repetitive for the experienced investigator and yet not enough for a new investigator. As an industry we need to move toward customizing training to qualify investigators, it’s not a one size fits all.”
The investigators and sponsors also stress the importance of applying GCP principles in a real-world setting. The sponsors recommend actively engaging trainees by providing them with examples of real-world GCP principles that focus on applications in daily clinical research practice. The investigators suggest increasing the use of mentors who can guide new investigators through the aspects of GCP in a clinical setting and ensure they fully understand what is required to conduct a clinical trial.
“You know those real world examples, having someone presenting live in the teleconference that is the key opinion leader in the field as part of the presentation, and taking questions from the research coordinators and the (principal investigators), I think you get better attendance, I think you get better interaction and the information is retained,” noted one sponsor.
“In this day and age with so many inputs in our lives with the (electronic medical record), email, etc., the expectation is we need that information at the time you’re using it,” said one investigator.
CTTI said its findings suggest there is an imminent need for significant improvement in the design, content and presentation of the GCP training. Rae Holliday of CTTI said the findings described in the paper were incorporated into recommendations about what the educational programming should include, such as a wide selection of unstructured and structured approaches that would improve the trainees’ knowledge and skills as well as training that uses a structured, trainee-focused approach with measurable outcomes.
The abstract is available at https://bit.ly/2utt3oO.
The recommendations can be read at: https://bit.ly/2UvElnf.