The Historical Trial Data Sharing Initiative enables the sharing of historical trial data to maximize the value of clinical data collected in the control arms of clinical trials. Explore the materials below to learn more about our findings. Please note, the Historical Trial Data Sharing Initiative was formerly known as “Placebo and Standard of Care.” We are continuing to update our assets to reflect this name change.
Historical Trial Data Sharing (Controls)
|Sharing Historical Trial Data to Accelerate Clinical Development||Describes a solution that is being developed to specifically enable data sharing across the biopharmaceutical industry and some of its early successes.|
|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 Historical Trial 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.|