Mapi is an established global industry leader in designing and conducting all aspects of prospective studies that are utilized to evaluate product effectiveness and safety in targeted populations. A prospective study asks a specific question (usually about how a particular exposure affects an outcome), recruits a group of appropriate participants, and looks at the exposures and outcomes of interest in these people over the following months or years. A prospective observational study is normally used to look at the effect of suspected risk factors that cannot be controlled experimentally, such as the effect of smoking on lung cancer.
Registries are observational studies that are conducted either pre- or post-approval of a product, and are generally classified as disease, product, or pregnancy exposure. The FDA’s Guidance for Industry: Good Pharmacovigilance Practice and Pharmacoepidemiologic Assessment defines a registry as:
“An organized system for the collection, storage, retrieval, analysis, and dissemination of information on individual persons exposed to a specific medical intervention who have either a particular disease, a condition (e.g., a risk factor) that predisposes [them] to the occurrence of a health-related event, or prior exposure to substances (or circumstances known or suspected to cause adverse health events.”
Mapi has a specific expertise in the design and conduct of the types of Registries which are often used to:
- Confirm correct product use
- Identify and quantify SAE rates
- Evaluate disease outcomes (e.g., survival rates, pregnancy)
- Identify off-label use
- Monitor adherence to treatment guidelines
- Understand actual use
- Obtain information to better inform patients and prescribers
Registries are used to track patient treatments and outcomes, clinical effectiveness and safety of a product often to fulfill post-marketing requirements. Clinical and pharmacoeconomic outcomes may be captured in a registry to demonstrate cost-effectiveness to managed-care organizations. Registries are particularly useful when dealing with a rare disease, rare exposure or special population. Periodic registry data reports to investigators and sponsors to provide qualitative feedback on the use of a pharmaceutical or biotech product, which may impact practice patterns and product use. Similarly, implementation of a new protocol or process in the clinical setting, and its impact on providing quality healthcare, may be demonstrated and tracked in a registry for the purpose of continuous quality.