About this Trial Results Database
This database will facilitate fair and balanced reporting of all Roche-sponsored Phase II-IV clinical trials and of Phase I trials in patients, for Pharmaceuticals and interventional clinical trials for Diagnostics, including those not published in the scientific literature. It is intended to be used predominately by physicians and other health care workers as a tool to access information on trial results. The information presented in the clinical trial study results database is described in scientific terms. The results database is populated with Roche clinical trials that fit the following criteria:
All Roche-sponsored interventional Phase I trials in patients completed after December 1, 2006 on any approved product;
All Roche-sponsored interventional Phase II-IV trials completed after October 1, 2002 on any approved product;
All retrospective Roche-sponsored interventional Phase II-IV trials completed for products that received first approval in first indication after October 1, 2002;
Diagnostic interventional clinical trials completed after October 1, 2002 on any advanced diagnostic product;
Results will be published within 1 year of trial completion (unless restricted by journal publication timing or pending regulatory filing).
Clinical trial results will also continue to be published through peer-reviewed journals, subject to the discretion of the journal editors. References will be provided in the clinical trial results database for key study results disclosed in the scientific literature. If a study is under review by a peer-reviewed journal, which prohibits pre-publication of results, the results will be posted at the time of the journal publication. An explanation will be placed on the database, in accordance with the timelines proposed in the preceding paragraph, while publication of the manuscript is pending. In some instances, there may be a delay in posting complete trial summaries due to the need to seek intellectual-property protection or to comply with confidentiality provisions in agreements with other parties. In such cases, an explanation will be placed on the database.
To understand more about the exact fields that are presented in the results database click here.
About This Database
This database is populated with information on the results of Roche-sponsored clinical trials.