Many medical publication professionals are aware of unpublished negative data from clinical trials and many believe obligations to make these data available should go beyond current legal requirements in the US and the EU. This is according to a new survey conducted during August by Ryan Woodrow of Woodrow Medical Communications and colleagues from Dianthus Medical, Network Pharma, Informa Healthcare Communications and Eastmond Medicomm. The research findings are scheduled to be published in Current Medical Research & Opinion next year.
The survey found that 58 percent of respondents were aware of negative data from any clinical trial remaining unpublished, while 32 percent were aware of negative data from a trial in the past three years that had not been published.
Of those professionals who were aware of selective data publication, 40 percent said an overriding reason for withholding data was that the compound in question had been discontinued. While 36 percent cited journal rejection of the data, 31 cited poor trial design/methodology. Lack of resources, budget or key staff; damage to the product profile; lack of thought or discussion about making the data public; and investigator unwillingness to publish the data were other key reasons cited. About 14 percent said the data had been superseded.
The researchers found that 44 percent of respondents felt data should be made available prior to Phase II clinical trials, which would be earlier than under current US and EU legal requirements. Among these respondents, 10 percent believed the data should be available from preclinical trials onwards and 11 percent from the discovery phase.
For the type of data for publication, 33 percent of respondents said all analysed data, including all protocol-specified/exploratory endpoints (but not raw, patient-level data) should be made available. Nearly 22 percent felt all analysed data should be published, but including only protocol-specified endpoints (not exploratory or raw data). About 20 percent wanted all data published, including raw data; and 18 percent said just a brief report with summary tables should be available.
Asked about the main barriers to publishing all clinical trial data in the future, respondents cited fear of data misinterpretation; negative impact on trial protocols; lack of resources/budget; reservations about enabling others to analyse raw data; and protection of intellectual property rights. The authors concluded that the views of medical publication professionals should be taken into account in the drafting of guidelines and legislation relating to publications.
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