Moving towards a data quality by design (DQbD) approach at all stages of drug development — from planning, design, site selection, study conduct, data collection and transfer, and statistical analyses — will improve the quality of data in multiregional clinical trials (MRCTs). This session will bring together the pharmaceutical industry, data management organization, and regulatory/review perspectives, with case examples illustrating how the DQbD approach can be applied to ensure patient safety, promote protocol adherence, improve the quality and integrity of the data that are generated, processed and analyzed, and enhance the overall efficiency to bring important therapeutic products to patients who need them.

Learning Objectives:
Discuss how to apply the concept of DQbD to drug development process
Identify appropriate clinical trial design and endpoints
Describe new approaches to infusing quality into protocol design and site selection Perform accurate recording and transfer of data through different levels of data processing Discuss the role of performance metrics and benchmarking in ensuring quality outcomes Discuss the role of DQbD in clinical trials to improve and ensure patient safety, data quality/integrity.