European Organisation for Research and Treatment of Cancer, Av. E. Mounier 83/11, 1200, Brussels, Belgium.
Laboratory of Digestive Oncology, Department of Oncology, KU Leuven, Leuven, Belgium.
Ther Innov Regul Sci. 2023 Sep;57(5):1113-1120. doi: 10.1007/s43441-023-00553-x. Epub 2023 Jun 30.
To safeguard the safety and interests of subjects participating in clinical trials, their conduct is heavily regulated. The EU Clinical Trials Regulation (CTR) 536/2014 brings fundamental changes that will require sponsors to adapt their current way of working. One major change is the significant shortening of the permitted reply timelines to requests for information (RFI), which may require adaptations to established processes within an organisation. This study aimed to assess these reply timelines at the European Organisation for Research and Treatment of Cancer (EORTC), a non-commercial sponsor. Additionally, it aimed to investigate how the impact of the different CTR requirements is perceived by the organisation's staff.
A retrospective analysis was performed to assess the length of reply to grounds of non-acceptance (GNA) timelines. Questionnaires were circulated to internal staff to assess their views on the impact of important changes the CTR introduces on the organisation's processes.
The average reply time to comments from regulators was 27.5 days, which is longer than the 12-day time limit required by CTR, which indicates that the organisation's processes require re-optimization to allow efficient activation of trials compliant with the new legislation. The majority of the staff that completed the questionnaire assessed the impact the CTR would have on the organisation to be positive. Finally, there was a large consensus about the changes related to the submission timelines, transition period and the user management of the Clinical Trial Information System (CTIS) having a very important impact on the organisation as a whole. Participants referred to the streamlined process of a clinical trial in different countries as foreseen in the CTR, as an aspect that would benefit the organisation.
For all retrospectively studied timelines, the average timelines to reply combined for competent authorities (CA) and ethics committees (EC) were longer than the 12 days allowed under the CTR. EORTC will have to adapt internal processes to meet the time limit imposed by the CTR without compromising its scientific integrity. The questionnaire respondents had the required expertise to provide an opinion on the CTR's impact on the organisation. There was a large consensus about the changes relating to the submission timelines having a very important impact on the organisation. This observation is in line with the results of the retrospective part of this study.
Based on the results of the retrospective and prospective parts of the study, it is clear that the shorter reply timelines are the main factor that will affect the organisation. EORTC has spent significant resources in adapting its processes to comply with the CTR's new requirements. Experience with the first studies under the new regulation can be utilized to implement further process adaptations.
为了保障参与临床试验的受试者的安全和利益，对其行为进行了严格的规范。欧盟临床试验法规（CTR）536/2014 带来了根本性的变化，这将要求申办方调整其当前的工作方式。一个主要的变化是，对信息请求（RFI）的回复时间大大缩短，这可能需要对组织内已建立的流程进行调整。本研究旨在评估欧洲癌症研究与治疗组织（EORTC）作为非商业性申办方的这些回复时间，EORTC 是一个非商业性的赞助商。此外，本研究还旨在调查该组织的员工如何看待 CTR 引入的不同要求的影响。
采用回顾性分析评估对不可接受性理由（GNA）回复时间的长度。向内部员工发放问卷，以评估他们对 CTR 引入的重要变化对组织流程的影响的看法。
回复监管机构意见的平均时间为 27.5 天，这超过了 CTR 要求的 12 天的时间限制，这表明组织的流程需要重新优化，以允许对符合新法规的试验进行有效的激活。完成问卷调查的大多数员工认为 CTR 对组织的影响是积极的。最后，大多数员工认为与提交时间、过渡期和临床试验信息系统（CTIS）用户管理相关的变化对整个组织具有非常重要的影响，这一点达成了共识。参与者提到了 CTR 预见的不同国家的简化临床试验流程，认为这是对组织有益的方面。
对于所有回顾性研究的时间线，负责机构（CA）和伦理委员会（EC）的回复平均时间都超过了 CTR 规定的 12 天。EORTC 将不得不调整内部流程，以满足 CTR 规定的时间限制，而不影响其科学完整性。问卷的回答者具有提供有关 CTR 对组织影响的意见的必要专业知识。与提交时间相关的变化被认为对组织具有非常重要的影响，这一点达成了很大的共识。这一观察结果与本研究回顾性部分的结果一致。
根据研究回顾性和前瞻性部分的结果，很明显，更短的回复时间是影响组织的主要因素。EORTC 已经投入了大量资源来调整其流程，以符合 CTR 的新要求。可以利用新法规下的首批研究经验来进一步进行流程调整。
