Adoption Maturity Model for Risk-based Quality Management (RBQM) in Clinical Trials.

Background: The global drug development regulatory community, through the International Council for Harmonisation (ICH) guidelines for the development of pharmaceuticals for human use, has long encouraged the use of quality by design (QBD) principles in clinical trials. Risk-based Quality Management (RBQM) offers an approach to improve clinical research quality and performance by identifying and mitigating risks related to critical safety and efficacy data based on Quality by Design (QbD) principles. Several studies have been published quantifying current levels of RBQM adoption, but a systematic study mapping the stages of adoption maturity has not been conducted. This lens is needed to inform organizations on adoption paths that have been followed and to facilitate more rapid RBQM adoption considering recent regulatory guidance (ICH E6 R3).

Methods: The Tufts Center for the Study of Drug Development conducted a global online survey and collected responses from 119 individual pharmaceutical and biotechnology companies. Responses related to the use of 32 distinct RBQM practices in ongoing clinical trials in late 2022 and early 2023, and were analyzed and used to (1) develop an adoption maturity model, (2) map levels of adoption by company size, and to (3) isolate the characteristics and barriers experienced by five RBQM maturity cohorts: Innovators, Early Adopters, Early Majority, Late Majority, and Resisters.

Results: RBQM components are used primarily by larger companies-those conducting more than 25 clinical trials annually. These companies tend to fall in the Innovators, Early Adopters, and Early Majority RBQM maturity cohorts. These companies have implemented nearly all of 32 RBQM components in at least one trial. The most common areas of reported use are in the documentation and resolution of risk areas. The areas with lowest rates of use are the detection of duplicate patients, statistical data monitoring, reduced/targeted SDR, identification of critical to quality factors, and documentation of updates to definitions.