Clinical Research and GCP Update

27 CRITICAL sponsor findings – Data Integrity Control

• The organisation permitted unplanned reviews of unblinded clinical trial data (in double blind trials) for business decision purposes. • Had a significant potential to introduce bias into the trial, impacting data integrity. • There were several examples where management had requested unblinded data to be provided to them for double blind clinical trials. • This request and review was outside of any agreed interim/preliminary analysis described in the protocol, prior to formal completion of the trial.

These unplanned reviews of unblinded data were interim analyses, as in most cases the intention was to compare treatment arms with respect to efficacy and safety prior to formal completion of the trial to make internal decision regarding the future of development programmes, resource and planning.

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28 CRITICAL sponsor findings – Data Integrity Control

• For some trials, the unblinded data was reviewed before the Statistical Analysis Plan (SAP) was finalised. • There was a lack of adequate rationale and review of the potential consequences considered and documented for unblinding for unplanned interim analysis. • Senior management within the organisation were able to authorise their own requests to unblinded data.

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