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PSI Conference 2018: Publishing a Bayesian Study - a sometimes overlooked hurdle

06 June 2018

Bayesian approaches are being increasingly employed in clinical study design, particularly in Early Development. For example, at UCB, we aim to conduct all our proof of concept studies within a Bayesian framework. Consequently, we anticipate an increase in clinical publications containing Bayesian analyses. In this talk we discuss the additional challenges of publishing results obtained from a Bayesian design. For example, whilst in any pharmaceutical company, the stakeholders who sign off on such clinical designs may all be familiar with and appreciate the Bayesian approach, there are additional stakeholders involved in getting a paper published. In particular, it may be difficult to persuade anonymous referees of the benefits of a Bayesian approach and of an appropriate way of describing such methods.

Additional word count will need to be used to describe priors and the key success criteria. There may be a reluctance to publish any additional success criterion that relates primarily to internal decision-making. Methods using some form of adaptive downweighting e.g. robust priors to address potential prior-data conflict or mixture likelihoods to deal with outliers may be new to reviewers and viewed with some suspicion. In addition to outlining key issues for consideration, we will highlight useful literature – both guidelines and example publications - and discuss our own experience and learning.

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