CTTI released new recommendations proposing a new approach for investigator qualification today during a public webinar. This approach goes beyond repetitive one-size-fits-all training and includes individual experience and protocol-specific preparation.

 

While Good Clinical Practice (GCP) training is widely used as the industry standard for investigator qualification, there is little evidence that completion of GCP training alone sufficiently qualifies investigators and their delegates to conduct quality clinical trials. In fact, the most common deficiencies noted during investigator inspections are often directly related to GCP principles. Furthermore, redundant GCP training creates an unnecessary burden for site teams and limits the opportunity for more valuable, protocol-specific learning and preparation.

 

To address this challenge, CTTI convened a team of experts and leaders across the clinical trials enterprise to develop new recommendations and resources that can help in implementing a more efficient and effective means of qualification. CTTI’s recommended approach recognizes previous training and experience, identifies gaps in knowledge and skills, and improves understanding of how to apply GCP principles to the conduct of clinical trials.

 

By implementing CTTI’s recommendations, stakeholders could improve the execution of study protocols and ultimately the overall quality of trials. The recommendations can also help stakeholders create a culture of collaboration and provide ongoing support through formalized mentorship and knowledge-sharing platforms.

 

Recognizing that successful clinical trials require not only qualified site teams but also well-designed protocols and robust site-based infrastructure, CTTI encourages site teams to use these new recommendations in conjunction with its Quality by Design recommendations on protocol development and Investigator Community recommendations for a holistic approach to conducting quality clinical trials.

Although good clinical practice (GCP) training has long been considered the industry standard for ensuring investigators are qualified for the high-quality conduct of clinical trials, little evidence has been collected to determine whether it actually provides the knowledge and skills to equip investigators and their delegates to conduct clinical trials.

To address this issue, CTTI convened an expert meeting in December 2017 to discuss action that can be taken to inform the efficient and effective qualification of site investigators and their delegates. The meeting (see one-page summary) included representatives from pharmaceutical companies, government, research sites, contract research organizations, patient representatives, and other groups.

Meeting participants collaborated to refine a draft framework defining characteristics synonymous with the quality conduct of clinical trials. They discussed the need to shift the focus from individual investigators to the entire study team and identified value in mentorship, just-in-time training, and peer-to-peer networks to support site personnel in their specific roles. In addition, participants probed how it may be possible to develop and deliver more patient-centric training, foster a culture of learning, and drive the evolution of investigator qualification to include more adult learning approaches and a focus on how to apply knowledge—not just recall it. Attendees also identified the need for a harmonized system to better help sponsors identify suitable sites without mandating specific training.

As a next step in its Investigator Qualification work, CTTI will develop recommendations and resources to improve the quality of trial conduct through optimized approaches to qualifying investigators and their delegates.

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.

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).