Details
- Status
- Closed
- Opening date
- Deadline
- Department
- Directorate-General for Health and Food Safety
Target audience
Public health community
Why we are consulting
Period of consultation
From 1 June 2016 to 31 August 2016.
Contributions to and results of the consultation
A summary of the responses is available here.
Below are the public responses to the above-mentioned public consultation:
- ACRO - Association of Clinical Research Organizations
- ACRP - Association of Clinical Research Professionals
- AESGP - Association of the European Self-Medication Industry
- Amgen, Inc.
- Anonymous contributor
- Anonymous contributor
- Anonymous contributor
- Anonymous contributor
- Anonymous contributor
- Anonymous contributor
- Anonymous contributor
- Anonymous contributor
- BEUC - The European Consumer Organisation
- Cancer Research UK / British Heart Foundation
- Corrado Iacono
- Deborah Collyar
- EAHP - European Association of Hospital Pharmacists
- EFA - European Federation of Allergy and Airways Diseases Patients' Associations
- EFPIA - European Federation of Pharmaceutical Industries and Associations
- EORTC - European Organisation for Research and Treatment of Cancer / ECPC - European Cancer Patient Coalition
- EPF - European Patients Forum
- ESCMID - European Society of Clinical Microbiology and Infectious Diseases
- EUCROF - European CRO Federation
- EUFEMED - European Federation for Exploratory Medicines Development
- EuropaBio - European Association for Bioindustries
- Gilead Sciences International Ltd.
- GHP - Guild of Healthcare Pharmacists (UK)
- HLM - Health Literacy Media
- HRA - Health Research Authority (UK)
- iCAN
- International Kidney Cancer Coalition
- IPFA - International Plasma Fractionation Association
- Jeremy Dearling
- Katrin Leinweber
- KKS-Network - Network of Coordinating Centers for Clinical Trials (Germany)
- MRCT - Multi-Regional Clinical Trials Center of Brigham and Women's Hospital and Harvard
- MSD
- Nextrasearch di Gasparetto Adolfo & C.
- NIHR - National Institute for Health Research (UK)
- PRC - Please Read Carefully
- Professor DK Theo Raynor, University of Leeds (UK)
- Shaun Treweek, Health Services Research Unit, University of Aberdeen (UK)
- Shire Pharmaceuticals
- TEDDY - European Network of Excellence for Paediatric Clinical Research
- Teva Pharmaceutical Industries Ltd.
- TransCelerate BioPharma, Inc.
Targeted stakeholders
All citizens and organisations are welcome to contribute to this consultation.
Objective of the consultation
With this public consultation the Directorate General for Health and Food Safety, DG SANTE, intends to seek the views of stakeholders – and other interested parties – on 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.
Article 37 of the Clinical trial Regulation (EU) No 536/2014 requires that sponsors provide a summary of clinical trial results in the EU Portal and Database, in a format understandable to laypersons. The main objective of this document is to provide recommendations and templates for the production of a summary of clinical trial results for laypersons by sponsors and investigators, in accordance with Annex V of the EU Clinical Trials Regulation.
The consultation document
The consultation document can be downloaded here.
Protection of personal data
The policy on "protection of individuals with regard to the processing of personal data by the Community institutions" is based on Regulation (EC) N° 45/2001 of the European Parliament and of the Council of 18 December 2000. More information is available here.
Specific privacy statement
Please consult the Privacy Statement to be downloaded here.