Navigating Clinical Trials Regulation (EU) 536/2014 - Are We There Yet?

Posted by Jim Lane on Aug 5, 2020 10:25:35 AM

The short answer is, no, we are not there yet. In fact, “there” is now further away.

The new Clinical Trial Regulation EU 536/2014 will replace the 2001/20/EC Directive, and is designed to ease the path of clinical trials conducted in different EU member states and non-member states. The 2001 Directive was open to individual Member State interpretation, which resulted in inefficiencies due to discrepancies in the laws among countries. The purpose of the new binding regulation is to create and enforce a single standard, meaning sponsors won’t have to navigate different sets of regulations in different nations.

When fully implemented, the 2014 regulation will be a significant step toward streamlining the process of bringing a new product to market. The main goals of the regulation are:

  • To encourage more clinical study sponsors to conduct trials across EU member states
  • To sharpen the criteria for what a clinical trial is and does
  • To make the EU member states attractive locations for clinical trials
  • To increase the safety standards of clinical trials
  • To increase transparency of trial data
  • To ensure final publications are written in a way that allows the general public to understand them 

So far, however, the transition to regulation has been greatly delayed and complicated.


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Everything Depends Upon the Clinical Trials Information System (CTIS) Portal

To a casual observer, it would make sense that regulations published in 2014 should be fully in place in 2020, even withstanding Brexit. But the regulations hinge on the portal, which is how trial submissions and collaboration will be centralized. That portal has been dogged by many delays.

A 2019 audit of the portal revealed key problem areas that required solutions and so pushed the go-live date to the end of 2020. When Covid-19 hit, the EMA invoked its Business Continuity Plan in order to continue work during the pandemic, with staff working remotely, but progress on the portal lagged. At the June 2020 board meeting, it was revealed that the target for the CTIS to go live is now December 2021.

As I observed here in January of 2020, “Developing complex portal applications with deep functionality is not easy, and addressing one challenge often lifts the lid on several new ones.”


What the CTIS Will Bring to Future Clinical Trials

Put simply, without the CTIS portal, EU 536/2014 cannot repeal the 2001 Directive. The portal enables the centralization, standardization, and harmonization that the 2014 regulations call for. It will act as a giant funnel for information and collaboration that sponsors, investigators, consultants, and nation states will be able to access. When complete, the portal will be the single entry point for clinical trial submissions in the EU, and will be used to manage all associated information, communication, workflows, and timelines.

When the CTIS portal is up and running, Regulation 536/2014 will apply to new trials, as well as previously existing trials that are still ongoing three years after the repeal of 2001/20/EC.

Some of the benefits of the CTIS portal include:

  • Streamlined, harmonized electronic submission and assessment for clinical trials in multiple EU states
  • Improved collaboration, information-sharing, and decision-making
  • Increased transparency of information
  • Highest standards of safety for all trial participants

Barring further delays, the CTIS portal should be available to investigators, sponsors, and patients after December 2021. For more information about the forthcoming transition, consult the EMA’s Questions & Answers.

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Topics: Clinical Trial Compliance, Clinical Operations, Clinical Studies, Clinical trial protocols

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