University of Rochester Medical Center, Rochester, New York.
University of Rochester Medical Center, Rochester, New York.
J Pain. 2020 Sep-Oct;21(9-10):931-942. doi: 10.1016/j.jpain.2019.12.003. Epub 2019 Dec 13.
The estimated probability of progressing from phase 3 analgesic clinical trials to regulatory approval is approximately 57%, suggesting that a considerable number of treatments with phase 2 trial results deemed sufficiently successful to progress to phase 3 do not yield positive phase 3 results. Deficiencies in the quality of clinical trial conduct could account for some of this failure. An Initiative on Methods, Measurement, and Pain Assessment in Clinical Trials meeting was convened to identify potential areas for improvement in trial conduct in order to improve assay sensitivity (ie, ability of trials to detect a true treatment effect). We present recommendations based on presentations and discussions at the meeting, literature reviews, and iterative revisions of this article. The recommendations relate to the following areas: 1) study design (ie, to promote feasibility), 2) site selection and staff training, 3) participant selection and training, 4) treatment adherence, 5) data collection, and 6) data and study monitoring. Implementation of these recommendations may improve the quality of clinical trial data and thus the validity and assay sensitivity of clinical trials. Future research regarding the effects of these strategies will help identify the most efficient use of resources for conducting high quality clinical trials. PERSPECTIVE: Every effort should be made to optimize the quality of clinical trial data. This manuscript discusses considerations to improve conduct of pain clinical trials based on research in multiple medical fields and the expert consensus of pain researchers and stakeholders from academia, regulatory agencies, and industry.
从第 3 阶段镇痛临床试验进展到监管批准的估计概率约为 57%，这表明许多在第 2 阶段试验结果被认为足够成功而进入第 3 阶段的治疗方法并没有产生积极的第 3 阶段结果。临床试验实施质量的缺陷可能是导致这种失败的部分原因。为了提高检测能力（即试验检测真实治疗效果的能力），召开了临床试验方法、测量和疼痛评估倡议会议，以确定试验实施中可能需要改进的潜在领域。我们根据会议上的演讲和讨论、文献综述以及本文的反复修订提出了建议。这些建议涉及以下领域：1）研究设计（即提高可行性），2）站点选择和员工培训，3）参与者选择和培训，4）治疗依从性，5）数据收集，以及 6）数据和研究监测。实施这些建议可能会提高临床试验数据的质量，从而提高临床试验的有效性和检测能力。未来关于这些策略效果的研究将有助于确定为开展高质量临床试验而有效利用资源的最有效方法。观点：应尽一切努力优化临床试验数据的质量。本文根据多个医学领域的研究以及来自学术界、监管机构和行业的疼痛研究人员和利益相关者的专家共识，讨论了改进疼痛临床试验实施的注意事项。
