Large streamlined studies (LSSs) and registries -- areas of extensive experience for UBC -- are being used with increasing frequency for post-approval safety surveillance, risk assessment and risk management. These studies permit the collection of data from large cohorts of patients, which can mimic real-world settings. LSSs are typically driven by the collection of safety endpoints or effectiveness data. They can be implemented either at the time of launch, gaining the drug sponsor rapid assessment of launch data, or at post-approval – often in comparison to already approved products.
Typically, a large streamlined study:
- Is based on epidemiologic principles
- Addresses drug safety under conditions that reflect actual use
- Utilizes simplified study protocols, with well-defined endpoints
- Gathers data using brief and easy-to-complete and process case report forms
- Involves few protocol-mandated physician visits or procedures
- Uses a high proportion of community-based sites, rather than clinical researchers
- Involves the creation and management of an independent Adjudication or Endpoint Committee
- Collects simplified site start-up documentation
- Includes creation and management of the investigator study kit