Sprenger Kenneth, Nickerson David, Meeker-O'Connell Ann, Morrison Briggs W
1 Pfizer Inc, Groton, CT, USA.
2 Office of Scientific Investigation, Food and Drug Administration, Silver Spring, MD, USA.
Ther Innov Regul Sci. 2013 Mar;47(2):161-166. doi: 10.1177/0092861512458909.
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.
一项临床试验的质量可以通过该试验是否满足其各类客户的需求来评估，也可以通过其不存在重大缺陷或错误来评估。因此，为确保临床试验的质量，在试验设计过程中并行开展质量规划并在试验实施之前进行质量规划非常重要。质量规划包括前瞻性地确立质量目标以及开发开展高质量试验所需的产品和流程。本文描述了一家制药申办方针对一项临床试验开展的质量规划过程以及美国食品药品监督管理局（FDA）对由此产生的综合质量管理计划进行的试点审查。该试点证明了这一过程对于促使申办方和监管机构在临床试验质量方面达成一致的有用性。
