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Historical Trial Data Sharing (Controls) Solutions

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 Materials

Our Historical Trial Data Sharing (Controls) Initiative

Thinking Outside The Box: Historical Trial Data Sharing (Controls) Solution



Describes a solution that is being developed to specifically enable data sharing across the biopharmaceutical industry and some of its early successes.

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.

Presents examples of seven specific use cases for Historical Trial Data Sharing.

Provides guidance on the potential application of a large historical HTD database and provides examples for the possible implementation of historic data in seven specific use cases.