Regardless of approach, now more than ever, sponsor organizations require agility. The general feeling is that there will be a flurry of activity as the go-live date of the CTIS approaches and as more information becomes available for a Policy 0070 restart. So, how to proceed? Most sponsor organizations partnering with Real Life Sciences are taking a proactive approach. When Policy 0070 restarts, how many submissions will become due for each sponsor and when? In which order will they be requested e.g., oldest submissions first, new submissions first, submissions offering the great potential for secondary research etc.? How will this affect sponsors’ planning activities?.Notably, all new and ongoing studies must be under the Regulation three years after it comes into application, but depending on factors such as sponsor readiness, the number of active studies, and the time that these studies have left to run, there could be benefits to not immediately transferring all ongoing studies to the Regulation. Strategic decisions are needed when to move from the EU Clinical Trial Directive to the Regulation. ![]() How will resourcing be organized to ensure timely delivery on a global stage? Will the same resource be supporting implementation of the regulation and the policy? If so, what is the expected workload and how will this be managed? How will delivery be ensured for multiple documents with short timelines as well as translated documents now being required for some disclosures under the CTR? Other global disclosure activities e.g., Health Canada’s Public Release of Clinical Information, continue to be required.With the CTR and Policy 0070 both possibly active soon, it is a busy time for sponsors. Although no priority order for disclosure or timelines for this restart have yet been shared, many expect it to occur in the coming months, perhaps coinciding with the Clinical Trial Regulation coming into application. In early 2020, EMA invited interested parties to submit suggestions for how to restart this policy. Publication of clinical data under EMA Policy 0070 has been suspended since December 2018 (with the exception of documents related to COVID-19 treatments and vaccines) due to the ongoing implementation of EMA’s business continuity plan as well as the impact of COVID-19. In preparation of this launch, training material is available on the EMA website, with additional modules planned for release throughout 2021. To support the implementation of this regulation, the Clinical Trials Information System (CTIS), containing a centralized portal and database, is now expected to go live on 31 January 2022. The conduct of clinical trials in the EU is expected to change greatly once the Clinical Trial Regulation 536/2014 comes into application.
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