Opinion

EU CTR 536/2014: Are We Able to Reap the Benefits by Now?

Cite this article as: Jonnalagadda VG. EU CTR 536/2014: are we able to reap the benefits by now? Arch Iran Med. 2024;27(6):346. doi: 10.34172/aim.30011

As we enter 2024, it is necessary to look back on the major EU clinical trial regulation (EU CTR) after implementation from 31 January, 2022 to understand the major overhaul in the clinical trials arena.¹

To begin with, this regulation was designed to attract the sponsors to be perceived as easier when compared with other geographical regions and to increase the transparency alongside with regards to documentation, location, and status of the trial by introducing the new clinical trial information system (CTIS) platform.²

Secondly, although, EU CTR was implemented to establish a harmonious environment, it does face the challenges of variation, where the regulation is “silent” on various documents of the clinical trial application, i.e. protocol synopsis, curriculum vitae (CV) of the principal investigator (PI), and patient facing documents, in addition to the translated documents.³

Thirdly, request for information (RFI) from the regulatory authorities forms a major critical part of the process. The duration of 12 days is short and it will jeopardize the activities, quality and turnaround from the parties involved in this response, such as a contract research organization (CRO), translation vendors, and so on.⁴

Fourthly, the European Medicines Agency (EMA) organized a consultation with all stakeholders in May 2023 and in response to it, the revised rules were published in October 2023 on protecting personal and commercially confidential information while ensuring that information relevant to patients and researchers is made available.⁴

As we understand, any change to the system will start with denial, followed by anger, exploring and acceptance. Finally, keeping abreast of new information with changes, providing guidance to the sponsors, investigators, patients, stakeholders will a make a significant change to the clinical trials domain to deliver the improvements in efficiency, quality, and timeliness which requires patience and persistence.

When things look dark, there is always a “silver lining”.

References

1. Gefenas E, Cekanauskaite A, Lekstutiene J, Lukaseviciene V. Application challenges of the new EU Clinical Trials Regulation. Eur J Clin Pharmacol 2017; 73(7):795-8. doi: 10.1007/s00228-017-2267-6 [Crossref] [ Google Scholar]
2. European Commission. Fostering EU’s Attractiveness in Clinical Research: Commission Proposes to Revamp Rules on Trials with Medicines [Press Release]. 2012. Available from: https://health.ec.europa.eu/latest-updates/press-release-fostering-eus-attractiveness-clinical-research-commission-proposes-revamp-rules-trials-2012-07-17_en. Accessed December 2023.
3. European Medicines Agency (EMA). Clinical Trials Information System (CTIS)–Sponsor Handbook. EMA; 2023. Available from: https://www.ema.europa.eu/en/documents/other/clinical-trial-information-system-ctis-sponsor-handbook_en.pdf. Accessed December 2023.
4. Bamford C, Arias C. The EU Clinical Trials Regulation–Experiences from the First 18 Months. Regulatory Focus; 2023. Available from: https://www.raps.org/News-and-Articles/News-Articles/2023/11/The-EU-Clinical-Trials-Regulation-%E2%80%93-Experiences-fr. Accessed December 2023.