Recently, the ABPI has worked with its members to explore definitions and guiding principles to enhance transparency in clinical trial reporting. In discussion with members, it is clear that while greater transparency is broadly welcomed, there is a lack of consensus on the degree of disclosure required to constitute transparency. There is a need to determine what exactly is meant by ‘transparency’.
There is no set definition of transparency in the context of clinical trials reporting. Transparency can span everything from publicly registering trials in a timely fashion through to full disclosure of trial findings and of individual patient data. Industry is committed to the principle of greater transparency and it wants to see this implemented in a manner that supports good research, with data being analysed and interpreted appropriately.
One aim is to enable independent researchers to supplement companies’ own analyses of trial data, particularly through pooling of data from multiple studies. Such meta-analyses can provide clinical decision-makers and health policymakers with valuable information about the effectiveness and safety of inovative drugs.
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