The drug company Sanofi has failed to publish results for almost two thirds of the clinical trials it has conducted in the past decade, a major new tracking service has disclosed.
Conclusions Despite the ethical mandate and expressed values and mission of academic institutions, there is poor performance and noticeable variation in the dissemination of clinical trial results across leading academic medical centers.
1) Phase 2 and Phase 3 studies that are part of the submission package for a new medicine or new indication for regulatory approval of a previously approved medicine in the EU and US as of January 1, 2014. Approval must have been granted by both agencies, unless approval is only sought in either the EU or US.
2) For Phase 2 and Phase 3 studies approved in the EU and US prior to 2014, research proposals requesting data from Novartis will be reviewed on an individual basis and data provided if materially possible (it may not be possible to provide data from studies that are more than ten years old).
- For drugs and biologics:
- phase II – IV trials in patients sponsored by a Sanofi Company
- submitted to the US and EU regulatory agencies as part of the request for marketing authorization for new medicines or a new indication for an approved medicine;
- approved by both agencies on or after January 1, 2014;
- For new indications, only trials submitted in the application in support of the new indication
- provided that the trial results have been published
- Access to data from trials listed as available on the site is determined by the Independent Review Panel based on the scientific merit of the research proposal. In exceptional circumstances, access to data may be declined by the sponsor, for example, where there is a potential conflict of interest or an actual or potential competitive risk.
Roche is in the process of compiling a list of studies in scope. Roche will regularly update this list to add studies going back to January 1999. In the event that you cannot see a specific study in the Roche list, an Enquiry Form can be submitted to confirm the availability of the specific study.
Thank you, MouseDoctor. You are doing you research job here and I hope you'll find the truth. One would think that they were required by law to show all their cards…( the good, the bad and the ugly)
Sadly no and I can tell you already… I have found the ugly!