On 1 June 2016 the European Commission (“EC”) launched four new public consultations relating to clinical trials.

The public consultations will gather recommendations on the following topics:

Directorate General for Health and Food Safety (“DG SANTE”) invites all stakeholders to contribute in the following public consultations.

Public consultation on “Risk proportionate approaches in clinical trials”

The objective of this public consultation is to seek the views of stakeholders and other interested parties on the document regarding “Risk proportionate approaches in clinical trials” which has been developed in preparation for the implementation for the Clinical Trials Regulation (EU) No 536/2014.

The main objective of this public consultation is to provide further information concerning how a risk proportionate approach can be implemented in clinical trials. The document provides explanations and examples of the areas for potential adaptation, when sponsors follow a risk proportionate approach in the design and conduct of clinical trials. However it does not include information on investigator’s brochure, IMP dossier, labelling of the IMP and informed consent.

Contributions are to be sent by e-mail to: sante-b4-gl-risk-proportionate-approach@ec.europa.eu.

All consultations will be open for comments until 31 August 2016.

Public consultation on “Summary of Clinical Trial Results for Laypersons”

With this public consultation DG SANTE intends to seek comments from stakeholders concerning the “Summary of Clinical Trial Results for Laypersons”, which has been developed by the expert group on clinical trials in preparation for the implementation for the Clinical Trials Regulation (EU) No 536/2014.

According to Article 37 of the Clinical Trials Regulation (EU) No 536/2014 it is necessary that sponsors provide a summary of clinical trial results to the EU Portal and Database, in a format that is understandable to laypersons.

The main objective of this document will be to provide recommendations and templates for the production by sponsors and investigators of a summary of clinical trial results for laypersons, in accordance with Annex V of the EU Clinical Trials Regulation.

The considerations presented touch upon:

  • Development of the summary for a general public with no prior knowledge of the trial;
  • Development of the content, style, language and literacy level to meet the needs of the general public;
  • Keeping the document brief;
  • Focus on factual information;
  • Ensuring no promotional content is included; and
  • Involvement of patients, patient representatives, or advocates in the development and review of the summary information to ensure that it meets their needs.

Contributions are to be sent by e-mail to: sante-b4-gl-results-laypersons@ec.europa.eu.

All consultations will be open for comments until 31 August 2016.

Public consultation on the revision of the “Definition of Investigational Medicinal Products (IMPs) and use of Auxiliary Medicinal Products (AMPs)” (previously called “Guidance on Investigational Medicinal Products (IMPS) and Non-Investigational Medicinal Products (NIMPs))

This public consultation will provide insight by interested parties concerning revision of the document “Definition of Investigational Medicinal Products (IMPs) and use of Auxiliary Medicinal Products (AMPs)” in preparation for the implementation for the Clinical Trials Regulation (EU) No 536/2014.

The main objective of this revision is to align it with the Clinical Trials Regulation and with the latest scientific insights.

Contributions should are to be sent by e-mail to: sante-b4-gl-imp-amp@ec.europa.eu.

All consultations will be open for comments until 31 August 2016.

Public consultation on the revision of “Ethical Considerations for Clinical Trials on Medicinal products conducted with Minors”

The purpose of this public consultation is to seek the views of stakeholders concerning the revision of the document “Ethical Considerations for Clinical Trials on Medicinal products conducted with Minors” in preparation for the implementation for the Clinical Trials Regulation (EU) No 536/2014.

The main objective of this revision is to align the document with the Clinical Trials Regulation (EU) No 536/2014 and with the latest scientific insights on research which involve children.

The considerations presented touch upon:

  • Maturity of children, to respect the explicit wish of a minor to refuse participation in, or to withdraw from, a clinical trial at any time;
  • Requirement of participation of minors in the informed consent process;
  • Introduction of the term “agreement,” equivalent to the term “assent” in medical literature;
  • Assessment of the relationship between benefit, risk and burden;
  • Recommendations for emergency situations;
  • New insights on clinical trial designs and sampling methods;
  • Recommendations on clinical trials with female adolescents; and
  • Updates on data protection and GCP compliance.

Contributions should be sent by e-mail to: sante-b4-gl-ethics-minors@ec.europa.eu.

Consultation will be open for comments until 31 August 2016.

Participants in all four public consultations are reminded that their responses may be subject to a request for public access to documents under Regulation (EC) No 1049/2001.