Sponsor B, a top-10 pharmaceutical company, supports policies and actions that seek to appropriately enhance scientific exchange. They are committed to providing access to anonymized patient data and full Clinical Study Reports (CSRs) from their clinical trials to qualified scientific researchers. They are supportive of the European Federation of Pharmaceutical Industries & Associations (EFPIA) and Pharmaceutical Research and Manufacturers of America (PhRMA) guiding principles on data sharing. They strive to ensure that clinical data is published in a timely manner, objective, accurate, and balanced, regardless of the outcome of the trial.
Sponsor B has committed to posting synopses of CSRs from clinical trials of new medicines or new indications for approved medicines submitted after 2014 年 1 月 1 日 to its company website. Sponsor B has also committed to complying with the European Medical Agency (EMA) Policy 70, requiring the public posting of CSRs for all clinical reports submitted for central marketing authorizations after 2015 年 1 月 1 日. Additionally, Sponsor B has had multiple EMA Policy 43 Freedom of Information requests come through with very short notice and turnaround times.
