ICH Releases Guidance on QbD Approach for Clinical Development Plans
(Thursday, October 14, 2021)
Clinical trials conducted to support market approval of new drugs must follow a quality by design (QbD) approach where each clinical study, included in the market approval application, identifies factors that were critical to the quality of the study and how those risks were managed during study conduct. A new guidance from ICH released this week describes a broad overview of drug development planning listing regulatory expectations from FDA, EMA, and other agencies. These include various types of studies needed during the clinical development program, aspects of the data sources, and risk-based quality control measures employed in the studies. The guidance summarizes regulatory expectations from clinical trials by stating that the quality of the data generated from a trial is as important as protection of subjects (a topic discussed extensively in the ICH E6 guidance on Good Clinical Practices). The guidance states, “the purpose of a clinical study is to generate reliable information to answer the research questions and support decision making while protecting study participants. The quality of the information generated should therefore be sufficient to support good decision making.” Hence, clinical trials should be designed using prospective, multidisciplinary approach that starts with high quality protocols and processes that are proportionate to the risks involved in the trial, with clear communication (written documentation with training) of how the quality will be maintained. A clinical development program often contains sequential trials where the prior studies should inform the plan of later studies with each new data contributing to modification of the overall development strategy. Patient perspectives should be considered and addressed into the quality of the clinical data presented. The guidance deals with various aspects of quality by design in clinical trials in great details. Topics such as planning and implementation of a clinical study, approaches to identify critical to quality factors, defining the scope of a trial within the overall development program, impact of the CMC and non-clinical data for each trial, factors for various data elements are discussed. The guidance ends with a 17-point checklist to measure the QbD approach used in a drug development program. While most of the topics discussed in this guidance have been described elsewhere over the last two decades, this guidance is an invaluable reading material for all drug development strategists, seasoned and novices, alike.
Dr. Mukesh Kumar
Founder & CEO, FDAMap
Linkedin: Mukesh Kumar, PhD, RAC