The EU Clinical Trial Regulation: Big Data And ' Human Rights

• Jurisdiction: European Union
• Law Firm: Schoenherr Attorneys at Law
• Subject Matter: Food, Drugs, Healthcare, Life Sciences, Privacy, Technology, Data Protection, Biotechnology & Nanotechnology, New Technology
• Author: Ms Elena Todorova and Kristina Bozhinova
• Published date: 28 February 2023

The new EU Clinical Trial Regulation ("Regulation No 536/2014" or "CTR") was published in May 2014 as Regulation (EU) No 536/2014 of the European Parliament and of the Council of 16 April 2014 on clinical trials on medicinal products for human use. It repeals Directive 2001/20/EC and is applicable to a certain extent as of the end of January 2022.

The CTR will simplify and harmonise the procedures for authorising clinical trials in the EU. It is focused on more in-depth safety analyses and introduces damage compensation principles and the category of low-intervention clinical trials.

How will the Clinical Trial Regulation affect business?

The CTR will make it much easier for pharmaceutical companies to conduct multinational clinical trials, which is likely to increase the number of studies conducted in the EU.

As the CTR has been subject to public discussions for several years, most businesses involved are already in compliance with the requirements. The implementation of the CTR may have a significant impact on project budgets and will require additional time and resource management.

Since the CTR provides extensive guidance for safety reporting processes and strict timelines, businesses involved in clinical trials must rethink their timetables and leave more room for communication with the controlling authorities while preparing and submitting/updating safety reports.

As clinical trials must be summarised and published in a manner that is understandable to laypersons and within one year of their completion, coordinating and performing this task may also take additional time and have to be rationally budgeted. Businesses also must be aware that the controlling authorities may require updates of the published summaries in case of technical progress or international regulatory developments.

Businesses involved in clinical trials need to review their CTR compliance policies, align them with their data protection policies and ensure that both comply with GDPR requirements.

"Businesses involved in clinical trials need to review their CTR compliance policies, align them with their data protection policies and ensure that both comply with GDPR requirements."

What is CTIS and why is it so crucial?

According to the European Medical Agency ("EMA"), the Clinical Trials Information System ("CTIS" or the System) will be the single entry point for submitting information (the so-called EU portal) as stipulated in the CTR. The CTIS application form for a clinical trial...