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PSI Conference 2018: Using TransCelerate/Placebo & Standard of Care data, with Bayesian dynamic borrowing, to design a clinical study

06 June 2018

The TransCelerate consortium is an innovative and welcome initiative involving data-sharing of placebo data across multiple pharmaceutical companies, providing participating members with access to control arm data at the patient level: clearly a great help for designing studies in therapeutic areas where perhaps one’s own company’s experience is limited.

This talk will demonstrate the data re-use platform being developed in GSK (the "R&D Information Platform – RDIP"), where all data available to GSK scientists will ultimately be stored, including the TransCelerate data. We will show how RDIP expedites the collation of relevant historical data, with an example based on the detection of Adverse Events in Schizophrenia clinical trials.

From such data a meta-analytic prior is first derived, then mixed with
a vague alternative prior – which we call a “Cromwell” prior, for its ability to admit that informative historical data may turn out not to be relevant when confronted with data from a new randomised study. Bayesian dynamic borrowing methods are then used to develop and interrogate the potential designs of new clinical studies, with regard to their ability to identify key AEs with prespecified levels of confidence...

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