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Genzyme has a longstanding commitment to ensure that physicians and patients have access to all relevant information about the medicines we market and the investigational products we are developing. In 2005, we expanded the amount of medical research information we make public by posting information about ongoing and completed clinical trials on our own Web site and other widely-accessible sites. This initiative is consistent with our support for transparency throughout the biotechnology and pharmaceutical industries regarding drug-development information.
Posting Clinical Trial Results
Going forward, we will post clinical trial results for a new product within six months of its approval and will post results from subsequent clinical trials of the product within one year from the time of the trial's completion.
Trial results for products obtained through mergers and acquisitions will be listed within one year after a business decision has been reached to market those products under Genzyme's name. Results for products obtained through mergers or acquisitions that will not be marketed under Genzyme's name will not be posted.
Registering Clinical Trials
We register clinical trials both for our approved and our investigational drugs, devices, and biologics. We define hypothesis testing studies as well-controlled trials intended to provide meaningful results by examining pre-stated questions using predefined statistically valid plans for data analysis, allowing conclusions to be drawn to support product claims. We do not register clinical trials that are merely exploratory in nature. We also do not register studies of our products or investigational therapies sponsored by physician or academic investigators or partner companies.
Clinical trial information that we post on the Genzyme Web site will remain there for two years from the date the last patient enrolls in a study.