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European CTR implementation advances ethical assessment of clinical trials

Assessment process is being integrated into national laws

Noteworthy changes are in motion across the EU that will see the assessment of an ethical review of clinical trials left to local legislatures of EU member states. With the organisation of ethical assessment needing to be in line with the procedure and timelines set by EU regulations, there’s a lot for pharmaceutical companies to consider.

Before regulation is fully in force and the EU portal is functional, national governments need to discuss and implement the scheme of ethical assessment. This process of assessment may involve just one national Ethics Committee (EC) but also multiple Ethics Committees existing in one country with specific rules for assessment coordination.

While it seems to be easier for countries that already have an established Central Ethics Committee, like Bulgaria, Hungary or Latvia, it may become more problematic to develop a new organisation of assessment and operate within more strict timelines for those that have multiple Ethics Committees.

Is Europe ready for change?

The EU 536/2014 Regulation becomes applicable as soon as the EU portal and database is audited and production version goes live. Based on the officially available EMA calendar, this is due to happen in October 2018 and EU member states should have integrated the EC process into their national laws by then.

Europe is ready for change - there is still time for the process and laws to be introduced. In fact, this depends both on the current EC setting within each EU member state as well as on plans for changes of the current system of assessment.

Ethical assessment processes evolution

Comparing the assessment scheme, timelines and rules for formulation of the EC opinion established by the Directive 2001/20/EC and CTR we see that:

  1. It remains up to each EU country to ‘determine the appropriate body or bodies to be involved in the assessment of the application to conduct a clinical trial and to organise the involvement of ethics’.
  2. Timelines are becoming stricter with regard to the fact that compatibility with Regulatory Authority (RA) assessment must be ensured. Per the 2001/20/EC directive, assessment was independent from RA and this rule has created more flexibility for EC assessment timelines.
  3. EC opinion issued after review of documentation is one per EU member state, yet implemented into one single decision (which concludes RA and EC assessment) in the 536/2014 regulation.

Looking at the current situation in the European Union, the following schemes of ethical assessment can be observed:

  1. One national EC which gives one national opinion, as in Hungary.
  2. Multiple Ethics Committees located in hospitals/clinics or regionally affiliated to the sites that will be conducting the trial, where one of them is being selected to serve as the ‘central’ Ethical Committee to give an initial opinion. This scenario is typical for Poland and the United Kingdom.
  3. A similar situation as in point 2, yet the applicant needs to wait for the so-called ‘local Ethics Committee’s’ opinion, only then can the clinical trial be started - Czech Republic is an example.

Independently from the above variations, as per CTR - one single opinion needs to be provided. This leads to the conclusion that the settings presented in points (1) and (2) above could theoretically work after establishing certain rules of communication between the RA and the EC, as well as a clear process of selection of a Central ‘EC’ that will be dealing with a trial. Option 3 will no longer be possible because it does not respect the rule of one single opinion, therefore countries with such settings would need to eliminate the individual opions of Local Ethical Committees or create a scheme of cooperation that will allow the issuing of one single assessment result.

In Europe, most countries are working on new schemes of EC assessment. In Spain new rules of assessment have already been implemented into local law. A cooperation between Ethics Committees, Regulatory Agencies and Competent Health Authorities is based on the clear division of roles and responsibilities clearly addressed in the Royal Decree 1090/2014 as of 4 December, regulating clinical trials with medicinal products, Ethics Committees for Investigation with medicinal products and the Spanish Clinical Studies Registry.

As you may see in the figure above, among multiple Ethics Committees based on criteria set by the Spanish Agency of Medicines and Medical Devices, some of them are accredited to become responsible for assessment of clinical trials with medicinal products. There is a close collaboration between ECs and the agency in terms of ethical assessment preparation with clear rules for reporting, assessment, membership and technical requirements for ECs.

Similar settings have been proposed for Poland, where currently multiple Ethics Committees are operating. One of the ideas was to implement the accreditation of ECs, the limitation of its numbers (currently there are more than 50 ECs operating) and the introduction of an independent coordinator who would deal with a selection of the appropriate EC, timelines and financial aspects.

A complex process and a simple goal

Legislation changes in Europe in terms of ethical assessment are leading to the creation of new schemes of assessment and in most cases, are related to structural changes within countries. Although the process of change is complex, the main goal is the unification of the process of obtaining opinions to enable the more efficient launch of clinical trials.

Article by
Anna Kubik

is director of regulatory affairs at contract research organisation KCR

7th August 2017

Article by
Anna Kubik

is director of regulatory affairs at contract research organisation KCR

7th August 2017

From: Regulatory



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