Quality by Design in Clinical Trials: A Collaborative Pilot With FDA.

The quality of a clinical trial can be assessed by whether the trial meets the needs of its various customers, as well as by its freedom from critical deficiencies or errors. In order to ensure the quality of a clinical trial, it is therefore important to conduct quality planning in parallel with the process to design and prior to the conduct of the trial. Quality planning consists of prospectively establishing quality goals and developing the products and processes required to deliver a quality trial. This article describes the quality planning process conducted by a pharmaceutical sponsor for a clinical trial and the pilot review of the resulting integrated quality management plan by the FDA. This pilot demonstrates the usefulness of this process to enable alignment between sponsors and regulators concerning quality in clinical trials.