Moradi Hamid, Schneider Margaret, Streja Elani, Cooper Dan
Institute for Clinical and Translational Science, University of California Irvine, School of Medicine, Irvine, CA, USA.
Tibor Rubin, VA Medical Center, Long Beach, CA, USA.
J Clin Transl Sci. 2021 Aug 13;5(1):e175. doi: 10.1017/cts.2021.837. eCollection 2021.
Clinical trials are a critical step in the meaningful translation of biomedical discoveries into effective diagnostic and therapeutic interventions. Quality by design (QbD) is a framework for embedding quality into the design, conduct, and monitoring of clinical trials. Here we report the feasibility and acceptability of a process for implementing QbD in clinical research at an academic health center via multidisciplinary design studios aimed at identifying and prioritizing critical to quality (CTQ) factors.
The Clinical Trial Transformation Initiative's Principles Document served as a guide to identify and categorize key CTQ factors, defined as elements of a clinical trial that are critical to patient safety and data integrity. Individual trials were reviewed in CTQ design studios (CTQ-DS) and the feasibility and acceptability of this intervention was examined through post-meeting interviews and surveys.
Eight clinical research protocols underwent the QbD evaluation process. The protocols ranged from multicenter randomized clinical trials to nonrandomized investigator-initiated studies. A developmental evaluation informed the iterative refinement of the CTQ-DS process, and post-meeting surveys revealed that CTQ-DS were highly valued by principal investigators (PIs) and resulted in multiple protocol changes.
The present study demonstrated that QbD principles can be implemented to inform the design and conduct of clinical research at an academic health center using multidisciplinary design studios aimed at identifying and prioritizing CTQ elements. This approach was well received by the participants including study PIs. Future research will need to evaluate the effectiveness of this approach in improving the quality of clinical research.
临床试验是将生物医学发现转化为有效的诊断和治疗干预措施的关键步骤。设计质量（QbD）是一个将质量融入临床试验设计、实施和监测的框架。在此，我们报告了通过多学科设计工作室在学术健康中心的临床研究中实施QbD流程的可行性和可接受性，该工作室旨在识别关键质量因素（CTQ）并确定其优先级。
临床试验转化倡议的原则文件作为识别和分类关键CTQ因素的指南，这些因素被定义为对患者安全和数据完整性至关重要的临床试验要素。在CTQ设计工作室（CTQ-DS）中对各个试验进行审查，并通过会后访谈和调查来检验这种干预措施的可行性和可接受性。
八项临床研究方案接受了QbD评估流程。这些方案涵盖了从多中心随机临床试验到非随机研究者发起的研究。一项发展性评估为CTQ-DS流程的迭代完善提供了依据，会后调查显示，主要研究者（PI）对CTQ-DS高度重视，并导致多项方案变更。
本研究表明，可以实施QbD原则，通过旨在识别CTQ要素并确定其优先级的多学科设计工作室，为学术健康中心的临床研究设计和实施提供参考。包括研究PI在内的参与者对这种方法反响良好。未来的研究需要评估这种方法在提高临床研究质量方面的有效性。
