2020 Update - The EU Clinical Trials Regulation – Everything You Need to Know

Posted by Jim Lane on Jan 27, 2020 1:51:01 PM

We released this summary of the EU Clinical Trials Regulation in April 2019 and it proved to be a very popular blog. Since then, there have been various communications from the EMA relating to the Clinical Trials Portal, which, as outlined in the blog, is a gating item in implementing the regulation. Notably, there have been significant delays in the portal’s development. Here, we give a high-level update on its progress.

When the regulation came into effect in 2014, it was expected that the portal would be submitted for independent audit in July 2017 to support a September 2018 go-live, ultimately allowing the regulation to become applicable in October 2018. When I wrote the original blog post last April, the expectation around delivery had already shifted to 2020. Unfortunately, “technical difficulties” have persisted, compounded by the Brexit-related relocation of the EMA to Amsterdam, and the further delay of the portal go-live date, which is now named the Clinical Trial Information System (CTIS).

In response, the EMA has renewed efforts to bring the CTIS to fruition, restructuring the delivery contract with a greater emphasis on delivery milestones and the implementation of an iterative, agile software development approach.

An audit readiness assessment of the CTIS conducted in December 2019 identified key problem areas, and lead to an updated plan detailing items still to be developed or fixed prior to the formal audit. The EMA, along with their IT vendor and product owners (representative experts from Member States, sponsor organisations, patient and healthcare professional associations) plan to spend the first few months of 2020 analysing and designing these items to ensure efficient delivery. Their stated goal is to have the CTIS audit-ready by December 2020. Based on previous audit-to-“go-live” timelines, that would point to an early 2022 deployment of the CTIS.

The delays in delivering the CTIS are frustrating. However, those of us working in the field of clinical trial portal applications probably have some sympathy with the CTIS project team.  Developing complex portal applications with deep functionality is not easy, and addressing one challenge often lifts the lid on several new ones.

For me, one of the biggest challenges for the CTIS throughout 2020-2021 will be aligning the agile development approach with equally agile decision-making. Managers and product owners may push developers to stick to schedules and processes, but if they don't hold themselves to the same standards when making decisions, the project will continue to struggle. In this instance, this challenge is compounded by the existence of a very large and disparate group of stakeholders working in an environment where broad concensus is required to advance. This isn’t conducive to rapid iterative agile development.

On the positive side, there is progress – slow but visible. Hopefully that will accelerate and we’ll see this important regulation coming into effect by 2022. One way or another, it won’t all be plain sailing and there is some way to go in this difficult journey. 

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Topics: Clinical Reseach, Clinical Trials, EU Clinical Trials, EU Clinical Trial No. 536/2014, EU Clinical Trial Regulation No. 536/2014, CTR

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