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.
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.
Providing controlled access to identified patient-level information is an essential element of realising the full potential of clinical data stores.
The current polarised debate is not helpful to anyone, least of all patients, says Alastair Kent of Genetic Alliance UK.
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.