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Introduction: 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. Methods: 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. Results: 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. Discussion: 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. Conclusion: 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. [ABSTRACT FROM AUTHOR]

Background: The U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA) began collaboration on Good Clinical Practice (GCP) inspections for marketing applications since 2009. The main characteristics of the GCP inspection processes between FDA and EMA were never evaluated. This is the first analysis comparing the GCP inspection processes between the two agencies., Methods: We examined and analyzed the key characteristics of the GCP inspection processes, including the geographical distribution, inspection types and timelines from application submission to final inspection reporting for marketing applications from September 2009 through December 2015., Results: Fifty-five shared applications were included for analysis. For these applications, a total of 433 GCP inspections were conducted in 47 countries. Most clinical investigator (CI) inspections were conducted in regions outside of each agency's own regulatory jurisdiction, while most sponsor/contract research organization (CRO) inspections were conducted in the U.S. by both agencies. Twenty-eight shared applications included common sites inspected by both agencies. There were 15 joint inspections conducted for seven of these applications and the remaining applications had common sites inspected by both agencies at separate times. Of the joint inspections, 73% were conducted in the U.S and 20% in the E.U. The median time from submission of an application to generation of final inspection reports was 232 days for FDA and 204 days for EMA, with no significant differences noted among applications with and without common sites., Conclusion: The inspection processes and timelines between the two agencies were similar, providing support for continued FDA-EMA GCP collaboration., (© 2022. This is a U.S. Government work and not under copyright protection in the US; foreign copyright protection may apply.)