We have not yet had the opportunity to analyse this specific study, yet we nevertheless welcome the continued focus on clinical trial transparency brought by the authors of “The TrialTracker: Automated ongoing monitoring of failure to share clinical trial results by all major companies and research institutions”, in F1000Research2015.
EFPIA Director General Richard Bergström emphasises that: “On the journey towards clinical data transparency, EFPIA and its members are ready to be held to account in terms of whether they live up to expectations.”
EFPIA and its members believe that sharing clinical trial information is in the best interests of patients, clinicians and medical research. EFPIA supports the intent of the new EU Clinical Trials Regulation 536/2014 and the European Medicines Agency’s transparency policies: Access to Documents (Policy 0043) and Publication and access to clinical-trial data (Policy 0070). These will ensure that all trials conducted in Europe will be registered and results published pro-actively after the end of the trial –within the time period stipulated by the Agency and at the time of approval of the medicinal product, at the latest.
Since the publication of the EFPIA/PhRMA principles for responsible sharing of clinical trial data (2014) companies have made significant progress in developing processes for clinical trial data access schemes, translating principles into practice. These principles support the legal framework, which can be considered the minimum requirement for compliance, and further increase the availability of the information on clinical trials. We now are seeing data being shared with researchers via some particularly innovative solutions and processes.
Clearly stated in the EFPIA/PhRMA principles is our aim to enhance public access to clinical trial information. We believe that to better understand the global transparency landscape, it is always necessary to assess where trials are published on registries other than clinicaltrials.gov, such as the EudraCT database or other global databases.
Delivering responsible transparency and data sharing is a process of continuous development. EFPIA and its member companies are committed to working with stakeholders to ensure that clinical trial information is shared responsibly, taking into account patient anonymity, maintaining the integrity of regulatory systems worldwide and continuing to support innovation with appropriate arrangements for commercial-in-confidence information.