The SPIRIT recommendations on randomized clinical trials have had little impact on reporting by industry sponsors but have had a positive impact on investigator-sponsored studies, say researchers.
In 2013 a checklist for trial reporting was published – the Standard Protocol Items Recommendations for Interventional Trials – with the aim of encouraging sponsors and researchers to develop comprehensive protocols for randomized clinical trials (RCTs).
The idea was to help industry and academia develop high-quality protocols and enhance the transparency and completeness of trial protocols for the benefit of investigators, trial participants, patients, and sponsors.
Earlier this year a multi-national group of researchers set out to examine what impact, if any, the checklist has had on trial protocol development in general and data reporting practices.
The researchers sought information from several clinical trial ethics committees in Switzerland, Germany and Canada and ended comparing 257 studies approved in 2012 with 292 studies cleared by regulators in the three countries in 2016.
Specifically, they looked at the proportion of reported SPIRIT items per protocol and the proportion of trial protocols reporting individual SPIRIT items.
Using this information, the team built regression model to explore factors associated with adherence to SPIRIT.
For each protocol, the team also extracted information on general trial characteristics and assessed whether individual SPIRIT items were reported.
Blithe SPIRIT?
And the findings from this analysis are somewhat mixed, with academia-led studies showing more of an impact then industry-sponsored studies.
The authors wrote, “in 2012, industry-sponsored RCT protocols were reported more comprehensively than investigator-sponsored protocols.
“After publication of the SPIRIT checklist, investigator-sponsored protocols improved to the level of industry-sponsored protocols, which did not improve.”
The researchers also found that alignment with the SPIRT checklist is stronger for studies in which the level of drug and CRO industry involvement is lower.
The authors said, “the following trial characteristics were independently associated with lower adherence to SPIRIT: single-center trial, no support from a clinical trials unit or contract research organization, and investigator-sponsorship.”
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