Placebo and Standard of Care Data Sharing Initiative enables the sharing of data to maximize the value of clinical data collected historically in the placebo and standard of care control arms of clinical trials. Explore the materials below to learn more about our findings.
Our Placebo and Standard of Care Data Sharing Initiative
Thinking Outside The Box: Placebo Standard of Care Data Solution
|Therapeutic Innovation & Regulatory Science (TIRS): Minimizing Patient Burden Through the Use of Historical Subject-Level Data in Innovative Confirmatory Clinical Trial||Discusses the use of historical control data to reduce the number of concurrent control subjects required in developing medicines for rare diseases and other areas of unmet need. Intended for a regulatory and industry audience, it provides a review of the current state of relevant statistical methods and of the uptake of these approaches, as well as the opportunities for broader use of historical data in confirmatory clinical trials.|
|Placebo and Standard of Care Data Sharing Use Case Studies||Presents examples of seven specific use cases for PSoC Data Sharing.|
|Development and Implementation of a Pharma-Collaborative Large Historical Control Database||Provides guidance on the potential application of a large historical PSoC database and provides examples for the possible implementation of historic data in seven specific use cases.|