Increasingly, authorities require a better understanding of the impact of products or medical technologies in the "real world", rather than relying solely on data generated in clinical trials. IMS can help you design and analyze observational studies that determine important outcomes including patient persistence and compliance and the burden of disease in clinical practice settings.
Apart from the direct costs associated with new treatments, it is increasingly important to determine the impact of treatment on patient-associated outcomes such as quality of life, compliance, patient preference and long-term safety. This information is required by some health authorities to evaluate the safety of a product or by companies to document additional information about a product.
A compelling need
There is an increasing need to fulfill health authority registration requirements, for post-launch evidence that a given product performs as expected in terms of safety and efficacy. Often called pharmacovigilance or post-marketing surveillance, these studies encompass diverse patient groups that are representative of the identified market, for the product.
The IMS HEOR Solution
IMS has extensive experience in gathering the required outcomes information for post-marketing evaluations. Our proprietary market forecasting tools and vast longitudinal, anonymised patient-level information are also frequently used to supplement these analyses. The design of each study depends on the information required and the intended audience. Studies include: