Solvay Pharmaceuticals conducts clinical trials worldwide to assess the safety and effectiveness of our compounds. Solvay Pharmaceuticals is committed to publicly disclose information on Solvay sponsored clinical trials. We feel that by doing so, we contribute to the transparency of the conduct of clinical trials and provide information that will be beneficial to patients, doctors, and the public.
Clinical Trial Registry
Solvay Pharmaceuticals has registered all Solvay sponsored interventional clinical trials in patients, excluding phase 1 studies, in a public clinical trial registry starting in July 2005 (www.ClinicalTrials.gov). Solvay follows industry wide commitments on trial registration as given in the Joint Position Statement on the Disclosure of Clinical Trial Information via Clinical Trial Registries and Databases, as originally issued by IFPMA, PhRMA, EFPIA, and JPMA in January 2005 and its revision in September 2005. Solvay discloses all clinical trial information, so-called data elements, as required by the FDA Amendments Act of 2007. Solvay will also register retrospectively any clinical trial for which we will post results in compliance with the State of Maine legislation (see below). On ClinicalTrials.gov the Solvay Pharmaceuticals sponsored studies can be recognised by Solvay being the information provider. In addition, on ClinicalTrials.gov there are trials registered by development partners and investigators supported by Solvay, but for which Solvay is not the trial sponsor and, therefore, also not indicated as the provider of the trial information.
Clinical Trial Results Database
Solvay Pharmaceuticals is committed to also comply with the new U.S. federal legislation (FDA Amendment Act of 2007) as well as the State of Maine legislation regarding the disclosure of clinical trial results. This means that for all interventional clinical trials in patients on Solvay registered pharmaceutical products that are FDA approved for marketing and are or have been dispensed, administered, delivered or promoted in the State of Maine Solvay will disclose, regardless of outcome, a trial results summary following ICH E3 format on Clinical Trial Results Database, a publicly accessible website owned by Solvay Pharmaceuticals. This will apply to Solvay sponsored trials initiated on or after October 15, 2002, on products for which Solvay is presently the labeller (NDA holder).