Snapshot: Clinical Trial Regulation 536/2014 – a Regulatory and Data Overview

The Clinical Trial Regulation 536/2014 and EU Portal is a hot topic around Europe. The regulation will officially be applicable in 2019 and requires publication within 6 months in the EU portal and EU database. There will then be a three-year transition period when the regulation comes into effect, and at the end of that period all clinical trials must switch to the new regulation.

The overall objectives of the Clinical Trial Regulation are:

  • To protect patients/trial subjects
  • To simplify the Clinical Trial Application (CTA) process, in particular for multi-country trials
  • To increase transparency

Clinical Trial Regulation 536 looks to harmonize processes across the EU member states:

clinical trial regulation 536/2014

What are some of the key features of Clinical Trial Regulation 536/2014?

  • Introduce the concept of co-sponsorship
  • Informed consent with new provisions for:
    • Broad consent (use of data outside the protocol)
    • Simplified consent for certain cluster trials
    • Specific groups (e.g. minors and incapacitated subjects)
  • Additional detail for conducting trials in an emergency setting
  • Damage compensation system to be set up by Member States
  • Designation of national contact points by Member States
  • Possibility for Member States to levy a fee
  • Archiving of the Trial Master File (TMF) for 25 years

What to consider in your regulatory and data strategy

Articles 80 and 81 give the European Medicines Agency (EMA) the responsibility to establish an EU Portal and Database with a single EU entry point for clinical trial applications. The EMA is holding various stakeholder meetings to consult on the process, and the EU portal is currently undergoing validation and audit testing.

It is estimated that larger pharmaceutical companies need approximately 9-12 months to prepare. This includes amending internal procedures, management of portal requirements and handling of the transition period on an individual trial basis and the Quality Management System (QMS).

Smaller companies can begin with the following steps:

  • Understand the impact of the regulation on various functions in the company
  • Understand the potential impact on the company
    • Which clinical trials are potentially affected
    • How will you handle the transition period
    • How will you handle the portal
  • Conduct a gap analysis and start the alignment process as soon as possible
  • Monitor progress
  • Get senior management on board with time and resources it will take to align the company with the regulation

What to consider in your data strategy

EU portal EMA

The development of a clinical data strategy during the transition period is essential as the following aspects need to be considered:

  • Data Protection
  • Commercially Confidential Information (CCI)
  • Data Transparency

Data Management, Biostatistics, Statistical Programming and Medical Writing are all impacted by this regulation, and therefore a strategy should be put into place accordingly.

Here are some questions you should consider:

  • Do you have in-house experts to support data anonymization?
  • Are individual rights protected?
  • If data is being transferred globally, where is it being stored/moved?
  • When might you have to disclose CCI?

Keep in mind the regulation states the “EU database should contain all relevant information as regards the clinical trial submitted through the EU portal. The EU database should be publicly accessible”.

This means companies need to prepare for data transparency and the de-identification and anonymization of data.

If your company is looking to prepare now for the Clinical Trial Regulation, CROS NT can support with regulatory and biometrics consultancy. We have an expert regulatory team knowledgeable on both EMA and FDA regulations for Clinical Trial Applications and submissions. Our biometrics team can support with a data strategy that guarantees data transparency and compliance with the new regulation. CROS NT also has a service in place to comply with data anonymization as laid out by the EMA.

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