The Clinical Trials Transformation Initiative (CTTI) recently released recommendations and resources proposing a new approach to investigator qualification – an approach that CTTI Executive Director Pamela Tenaerts said “goes beyond repetitive, identical training, and includes individual experience and protocol-specific preparation.”
Current US Food and Drug Administration (FDA) regulations require sponsors to select qualified investigators, and while good clinical practice (GCP) training is generally regarded as the industry standard for qualification, there is little evidence that this training alone is sufficient, according to CTTI.
Tenaerts explained that the new recommendations aim to provide sponsors and contract research organization (CROs) with a more efficient and effective means of qualification and help investigators and better prepare for a clinical trial.
“Ultimately, it’s about helping stakeholders streamline processes and target training to exactly what is needed, when it is needed,” she told us.
To develop the recommendations, CTTI brought together various experts to conduct a literature review, interviews, and a survey. The team also used other evidence-gathering methods to further explore the challenge, Tenaerts explained.
“This work led to the development of CTTI’s new recommendations and resources, which aim to help sponsors, CROs, and site teams work together to better qualify investigators and their delegates to conduct better, more efficient clinical trials,” she added.
Tenaerts said the new recommendations and resources help stakeholders recognize previous training and experience, and identify knowledge gaps and qualification aspects, beyond applying GCP principles.
“They also encourage collaboration, formalized mentorship, and knowledge-sharing platforms as new solutions to help ensure that site teams have the appropriate skills and knowledge they need to run high-quality clinical trials,” she explained.
CTTI proposes that the new recommendations be used in conjunction with its Quality by Design (QbD) recommendations on protocol development as well as its Investigator Community recommendations.
The organization in July released recommendations on the use of mobile technology for data capture and improved clinical trials. Also in July, CTTI’s new Patient Engagement Collaborative selected advocates to enhance the FDA’s understanding of how to best engage with patient communities.
The Association of Clinical Research Professionals (ACRP) also is developing competence standards for principal investigators (PIs) as part of its goal to reduce variability in performance across various clinical research roles.
CTTI is the product of a public-private partnership between Duke University and the FDA and aims to increase the quality of clinical trials.