Dombeck Carrie, Swezey Teresa, Forrest Annemarie, Tenaerts Pamela, Corneli Amy
Clinical Trials Transformation Initiative, Duke University, Durham, NC, USA.
Department of Population Health Sciences, Duke University School of Medicine, Durham, NC, USA.
Contemp Clin Trials Commun. 2022 Aug 17;29:100983. doi: 10.1016/j.conctc.2022.100983. eCollection 2022 Oct.
The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) has published the ICH E6(R2) Good Clinical Practice (GCP) guideline, which provides standards for the design, conduct, documentation, and reporting of clinical trials. Revision to E6(R2) is currently underway, aiming to adapt the guidance to the current regulatory environment. The Clinical Trials Transformation Initiative (CTTI) interviewed stakeholders, gathering their experiences implementing ICH E6 GCP and suggestions for revising the guidance.
We conducted a qualitative descriptive study using in-depth interviews. Participants were purposefully selected to ensure diversity in geography, research role, and type of institution. Participants reflected on their aspirations for the ICH E6 GCP revision and described sections of the guidance that they found most and least helpful. Narratives were analyzed using applied thematic analysis.
Many participants found ICH E6 GCP generally clear and helpful. They appreciated that the guidance is globally accepted and serves as a common standard for research worldwide. Participants also noted opportunities for improvement, suggesting that the revised guidance should incorporate flexibility, simplify requirements, and accommodate advances in research conduct. They highlighted areas where language should be updated and concepts clarified and expressed a desire for transparency and inclusiveness in the revision process.
Our findings show that many participants view the ICH E6(R2) guidance as helpful overall, although substantial room for improvement remains. We have provided the full report of these findings to ICH in hopes that it will be useful as the E6 GCP guideline is revised.
人用药品注册技术国际协调理事会（ICH）发布了ICH E6（R2）《药物临床试验质量管理规范》（GCP）指南，该指南为临床试验的设计、实施、记录和报告提供了标准。目前正在对E6（R2）进行修订，旨在使该指南适应当前的监管环境。临床试验转型倡议（CTTI）对利益相关者进行了访谈，收集他们实施ICH E6 GCP的经验以及对修订该指南的建议。
我们采用深入访谈进行了一项定性描述性研究。有目的地选择参与者以确保地域、研究角色和机构类型的多样性。参与者思考了他们对ICH E6 GCP修订的期望，并描述了他们认为最有帮助和最没有帮助的指南部分。使用应用主题分析法对访谈内容进行分析。
许多参与者发现ICH E6 GCP总体上清晰且有帮助。他们赞赏该指南被全球接受，并作为全球研究的通用标准。参与者还指出了改进的机会，建议修订后的指南应纳入灵活性因素、简化要求并适应研究实施方面的进展。他们强调了语言应更新以及概念应澄清的领域，并表达了对修订过程透明度和包容性的期望。
我们的研究结果表明，许多参与者总体上认为ICH E6（R2）指南是有帮助的，尽管仍有很大的改进空间。我们已将这些研究结果的完整报告提供给ICH，希望在修订E6 GCP指南时能有所帮助。
