Corneli Amy, Forrest Annemarie, Swezey Teresa, Lin Li, Tenaerts Pamela
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. 2021 Apr 16;22:100776. doi: 10.1016/j.conctc.2021.100776. eCollection 2021 Jun.
The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) is revising ICH E6 Good Clinical Practice (GCP). The Clinical Trials Transformation Initiative (CTTI) initiated a project to identify and provide ICH with stakeholders' priority areas and suggestions for revising ICH E6 GCP. We conducted a global online survey to identify areas of ICH E6 GCP that are and are not in need of revision. A total of 327 stakeholders completed the survey. Stakeholders represent many research roles and types of organizations, are employed in 39 countries, and conduct research in 153 countries. The ICH E6 GCP principles mentioned most often (range, 25%-29%) in need of revision were implementing systems that assure quality, providing medical care by qualified physicians/dentists, protecting confidentiality and privacy, obtaining informed consent, and documenting and storing information. The Investigator section (n = 244, 75%) and Sponsor section (n = 242, 74%) of ICH E6 GCP were identified as needing the most revision and the Investigator Brochure section (n = 166, 51%) as needing the least revision. The topic most frequently mentioned as needing revision is Monitoring (n = 146; 45%) in the Sponsor section. Although none of the principles or topics in ICH E6 GCP were identified as needing revision by the majority of stakeholders, a meaningful percentage of stakeholders identified areas that they believe need revision. These findings, which represent the views of a wide variety of stakeholders, may be useful to ICH for identifying where specifically to focus their revision efforts. CTTI provided the final report to ICH with the project findings for their consideration.
人用药品注册技术要求国际协调理事会（ICH）正在修订ICH E6《药物临床试验质量管理规范》（GCP）。临床试验转型计划（CTTI）发起了一个项目，以确定ICH E6 GCP的利益相关者优先领域，并为修订该规范提供建议。我们开展了一项全球在线调查，以确定ICH E6 GCP中需要和不需要修订的领域。共有327名利益相关者完成了调查。利益相关者代表了许多研究角色和组织类型，受雇于39个国家，并在153个国家开展研究。最常被提及（范围为25%-29%）需要修订的ICH E6 GCP原则包括实施确保质量的系统、由合格的医生/牙医提供医疗护理、保护保密性和隐私、获得知情同意以及记录和存储信息。ICH E6 GCP的研究者部分（n = 244，75%）和申办者部分（n = 242，74%）被确定为最需要修订的部分，而研究者手册部分（n = 166，51%）被确定为最不需要修订的部分。在申办者部分中，最常被提及需要修订的主题是监查（n = 146；45%）。虽然ICH E6 GCP中的原则或主题均未被大多数利益相关者确定为需要修订，但有相当比例的利益相关者确定了他们认为需要修订的领域。这些代表了广泛利益相关者观点的调查结果，可能有助于ICH确定其修订工作的具体重点。CTTI向ICH提供了最终报告，其中包含项目调查结果以供其参考。
