The Upcoming Clinical Trial Regulation and EMA Policy 0070 Restart? Are You Ready?

The conduct of clinical trials in the EU is expected to change greatly once the Clinical Trial Regulation 536/2014 comes into application[1]. 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. In preparation of this launch, training material is available on the EMA website, with additional modules planned for release throughout 2021.

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[2]. In early 2020, EMA invited interested parties to submit suggestions for how to restart this policy. 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.

With the CTR and Policy 0070 both possibly active soon, it is a busy time for sponsors. Questions to consider could include:

• 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[3], continue to be required. How will resourcing be organized to ensure timely delivery on a global stage?
• Strategic decisions are needed when to move from the EU Clinical Trial Directive to the Regulation. 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.
• 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?

So, how to proceed?  Most sponsor organizations partnering with Real Life Sciences are taking a proactive approach. 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. Regardless of approach, now more than ever, sponsor organizations require agility.

One factor repeatedly seen as a technology partner, is the rapid response time required as it becomes clear how quickly sponsors need to deliver once they are called upon by regulators to publish clinical trial documents. The fast-moving, deadline-oriented environment that exists once EMA or Health Canada requests trial data requires experience, agility, and a road-tested process.

As Policy 0070 and the Clinical Trial Regulation move back to the fore in the coming months, streamlined internal processes and the ability to handle backlogs will be required. By the end of 2022, it is hoped that the pace of submissions will become more fully understood. In the meantime, proactive preparation for an interesting start to 2022 may be prudent.

[1] https://www.ema.europa.eu/en/human-regulatory/research-development/clinical-trials/clinical-trial-regulation

[2] https://www.ema.europa.eu/en/human-regulatory/marketing-authorisation/clinical-data-publication

[3] https://www.canada.ca/en/health-canada/services/drug-health-product-review-approval/profile-public-release-clinical-information-guidance/document.html