Safety & Surveillance

The need for post-approval surveillance studies stems from inherent limitations in the clinical trial process used for regulatory approval. While studies of safety and efficacy in optimal populations are required to bring a drug or device to market, it is only through post-approval research and studies of patient outcomes from product use in real-world settings—by patients with co-morbidities and other risk factors—that strong evidence of the effectiveness and safety of a new product emerges.

Studies in larger populations, with real-world dosing, longer duration of exposure, long-term follow-up, and comparison data based on current physicians’ practices, are the most informative approaches to monitoring device and drug safety. Recent regulatory initiatives have confirmed the significant value and appeal of information generated from registries that are well-designed and appropriately conducted, analyzed, and reported.

Outcome offers the scalability and reliability needed to conduct long-term surveillance studies, registries, controlled distribution programs, and trials. Equally important, Outcome knows how to design and conduct studies that minimize (or even eliminate) duplicate reporting of safety events, which streamlines the efforts of corporate safety groups. Many of Outcome’s current programs fulfill a regulatory safety/surveillance reporting requirement; one example is a structured and seamless controlled distribution “no blood, no drug” web-based safety program.

More and more of our clients are increasingly considering pre-approval background, risk, and event rates before the product is introduced. Why wait until a news event or potential regulatory action calls for the initiation of a safety surveillance program? Proactive safety surveillance programs can be embedded within registries designed to understand or improve current medical practice, to obtain information about cost-effectiveness, or simply to describe the natural history of various diseases and conditions of interest. Outcome also provides consultation on the positives and negatives of these surveillance strategies.