The growing cost and complexity of clinical trials is threatening the ability to generate new evidence to improve healthcare. CTTI’s latest publication, Enhancing Clinical Evidence by Proactively Building Quality Into Clinical Trials, from the Quality by Design (QbD) Project summarizes recommendations and tools for streamlining clinical. The QbD framework aims to promote critical thinking about trial design and oversight to reduce errors that matter while eliminating non-essential activities. By applying these principles, efforts can be focused on activities that are necessary for the reliability of trial findings and the protection of study participants.

The official QbD recommendations were released in 2015. In the recent publication, the authors describe the process for recommendation development in which stakeholders from across the clinical trial enterprise, including patient advocates, clinical investigators, regulatory reviewers, and trial sponsors, contributed perspectives through workshops and qualitative interviews.

The article was published in the journal Clinical Trials. To read the full publication, click here.