SUMMARY OF THE RESPONSES TO THE PUBLIC CONSULTATION

RISK PROPORTIONATE APPROACHES IN CLINICAL TRIALS

RECOMMENDATIONS OF THE EXPERT GROUP ON CLINICAL TRIALS FOR THE IMPLEMENTATION OF REGULATION (EU) NO 536/2014 ON CLINICAL TRIALS ON MEDICINAL PRODUCTS FOR HUMAN USE:

The legislation for clinical trials has seen significant changes during the last decade, starting with the implementation, in 2004, of the Clinical Trials Directive 2001/20/EC (‘Directive’), continuing with the publication of the Good Clinical Practice Directive 2005/28/ECi in 2005 and more recently with the Clinical Trials Regulation (EU) No. 536/2014 (‘Regulation’).

Despite the relative flexibility of the legislation and guidelines (for e.g. ICH Guideline E6(R2) for Good Clinical Practice), it has been observed that in general a ‘one size fits all’ approach to the design and conduct of clinical trials has been followed to comply with the ethical and scientific standards of Good Clinical Practice (GCP). Some clinical trials, however, pose only a minimal additional risk to subject safety and/or trial integrity compared to normal clinical practice.

A proportionate approach to the design and conduct of clinical trials is therefore supported by the Regulation. This approach should be adapted to the risk to the subject and/or trial integrity of the research carried out, as well as to the risk related to the reliability of trial results.

This document presents a factual summary of the responses to the public consultation:

Read the pdf
Copyright Widler & Schiemann AG 2015. All Rights Reserved. /