Intermediate data analysis

When intermediate data analysis is provided for in the protocol (related to an adaptive or integrated design), a summary of these results has to be submitted in CTIS within one year after the completion of  the intermediate data analysis (art 37.8 of the CTR).

These results will be made public at the same time as they are submitted in CTIS except if the sponsor has opted to defer the publication in case of category I clinical trials (see section Deferral public disclosure).

The summary of results has to be in line with annex IV of the Clinical Trials Regulation and is restricted to the endpoints of the intermediate analysis as defined in the clinical trial protocol. The summary might  be expanded if justified, e.g. dose selection in integrated protocols based on safety or/and pharmacological data.

If necessary, intermediate data analysis results may be requested by the rMS as a condition in a clinical trial decision.

Intermediate analyses by a Data Monitoring Committee or DSMB falls outside the scope of article 37.8 of the CTR.