EFPIA and the Pharmaceutical Research and Manufacturers of America (PhRMA) have issued a joint proposal to enhance responsible clinical trial data sharing.
What does this mean practically for research in Europe, and what are the best practices for implementation?
August 27th, 2013 in Brussels.
Commercial confidentiality is a pinch point in roadmap for sharing clinical trials data
The question of what information – if any – should be defined as commercially confidential remains in dispute and this could hinder progress in creating a balanced, practical and trusted system for handling requests for data.
ABPI toolkit will help members manage clinical trials disclosure process
Research by the ABPI indicates current statistics on the state of play in transparency are not accurate. A toolkit will guide members in complying with disclosure requirements and generate more reliable information on compliance.
Global consortium is needed to manage access to patient-level data
Providing controlled access to identified patient-level information is an essential element of realising the full potential of clinical data stores.
It’s time for rapprochement between academic campaigners and pharma companies over clinical trials data transparency
The current polarised debate is not helpful to anyone, least of all patients, says Alastair Kent of Genetic Alliance UK.
European pharma industry stages workshop to consider practical issues involved in clinical trials data transparency
After setting out principles under which the industry is prepared to open up clinical study reports, the European Federation of Pharmaceutical Industries and Associations (EFPIA) is trying to reach a consensus with campaigners and regulators on how they should be applied in practice.
Senior Medical Officer, European Medicine’s Agency
Wellcome Research Fellow in Epidemiology, London School of Hygiene and Tropical Medicine
Director General, EFPIA
Vice President, European Patients’ Forum
The event will take place at Vlerick Business School, Manhattan Centre, Place Rogier, 21 Avenue du Boulevard in Brussels.