Sponsors of clinical trials comparing two drugs head-to-head can affect which drug is deemed superior, according to a study analyzing 192 drug comparison clinical studies.
Clinical trials comparing statins with other drugs were more likely to report results and conclusions favoring the sponsor’s drug instead of the comparator drug, the analysis found. The study, conducted by three researchers at the University of California, San Francisco, and one from the University of Leiden, the Netherlands, was published in the June 7 edition of PloS Medicine.
The study looked at results of 192 published randomized controlled trials from 1999-2005, involving seven different statins overall. Ninety-five of the trials were funded by industry, the study said, and approximately one-third did not disclose a funding source. The trials that did not disclose a funding source were less likely to have conclusions favoring the test drug, according to the analysis.
Nearly half of the trials did not have adequate blinding in place to ensure the scientists did not know which drug patients were taking, according to the analysis. Studies with adequate blinding were less likely to report results favoring the sponsor’s drug, the study found.
Industry group PhRMA criticized the study, saying it suggested the FDA did not regulate how companies used clinical trial results. Companies cannot use clinical trial information in marketing their products unless the FDA has approved it, and those who do not follow the agency’s rules will face enforcement action, PhRMA Senior Vice President Ken Johnson said. “It is simply not accurate to imply that the FDA would turn a blind eye to biased clinical trial data,” he added.
The study can be seen at medicine.plosjournals.org/perlserv/?request=get-document&doi=10.1371/journal.