Reforms of EU Clinical Trial Regulations Bring Cautious Optimism

Biotech ema clinical trials regulation

The EU’s clinical trial regulations received a major overhaul at the end of January 2022 to make trials easier to run across EU member states. It may bring some short-term chaos, industry insiders say, but down the road it is likely to pay off.

At the start of February, the EU’s new Clinical Trials Regulation (CTR) repealed the Clinical Trials Directive, which had overseen the running of EU clinical trials for about two decades. In addition, a new centralized database of clinical trials, known as the Clinical Trials Information System (CTIS), was launched.

With European bureaucracy often seen as holding back clinical trials, many see the reform as an attempt to compete better with the USA and China. The declared goal of the overhaul is to foster innovation and to facilitate bigger clinical trials in the EU. 

In some aspects, this can be seen as a European version of, the US database of ongoing clinical trials,” said Stephan Christgau, co-founder and Managing Partner of Nordic venture capital firm Eir Ventures.

A major advantage of the new set of rules is that, as a regulation rather than a directive, it carries more legal weight and reduces the burden of regulation and legislation carried by each individual member state. For clinical trials applications spanning several jurisdictions, coordination between different regulatory authorities is greatly simplified: one reporting member state will coordinate the assessment of the entire trial.

Cornelis ‘Kees’ Melief, CSO of the Dutch biotech ISA Pharmaceuticals, expressed excitement over the rollout of the new regulations. “It will enable us to more efficiently submit clinical trial applications to multiple EU countries at once and we hope it will help to bring innovation to the patients sooner,” he said.

There are other perks for biotechs, including the recognition of ‘low intervention clinical trials’ — trials that carry minimal risks and may be subject to reduced reporting and monitoring requirements. Safety reporting is also greatly simplified; instead of sending multiple submissions to different national authorities, companies can submit all documentation via the EudraVigilance system of the EMA.

Up until 31 January 2023, companies will be able to choose whether they want to apply for permission to start a clinical trial under the new rules or the old ones. Trials approved under the expiring rules will be able to run under the previous regulations for a further two years, but will need to be transitioned to the new system by 31 January 2025.

For both regulators and biotechs, there will likely be a learning curve, observers say. The CTIS will require input from administrators in different roles, and contract research organizations (CROs) that typically support companies will not be able to manage everything on their behalf. The national regulatory authorities of different countries will still have a say regarding which trials are run in their jurisdiction, which can create confusion.

[O]ver the transition period, [the CTIS] will likely be complicated to implement because there are still a large number of differences across each member state, particularly with the differing digitization status of each,” said Ilse Eder, the CEO of Vienna-based consultancy E&E CRO Consulting. “Another challenge will also likely stem from the fact that over the next two years, a sponsor will be able to choose to work with either the old directive or the new regulation, which could lead to additional confusion.”

A particularly sensitive issue for many biotechs could be the increased transparency mandated by the new set of rules. With some exceptions, all data in the CTIS will be public. Companies will need to learn how to navigate the new system in order to defer the publication of sensitive company information and protect the confidential information of patients.

Furthermore, the new clinical trial regulations have drawn criticism for the short time frames in which biotechs will need to answer questions about their applications: companies may find themselves having to answer long lists of questions within as few as 12 days or have their applications rejected. They will also face additional scrutiny when including vulnerable subjects such as pregnant women or minors in their trials. If they fail to recruit patients within two years of a trial being authorized, the authorization expires automatically. 

[I]t does place additional requirements on sponsors and there will be a need for more administrative oversight and resources for the management of clinical trials,” Christgau added. “Thus, even though the system will provide an increased granular overview of European clinical development activities, it may also add an additional layer of cost and complexity.

Despite the anticipated challenges, many industry observers are hopeful that the regulatory overhaul will initiate beneficial changes in the European biotech ecosystem and eventually simplify clinical trials. 

In the long run, it will definitely be a major improvement, because it centralizes and simplifies the clinical trial application process,” Eder added. “I see a trend for more consolidation within the supporting organizations as well, such as CROs.”

Cover image via Elena Resko

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