Competition shapes how sponsors comply with trial disclosure rules
Competition prompts drug firms to comply with trial disclosure rules more quickly, but it also drives them to make more extensive changes to stated objectives than they otherwise would, according to new research.
The study – conducted by researchers in the Netherlands and the UK – looked at how competition impacts how developers fulfil mandatory disclosure rules, focusing specifically on drug firms required to publish clinical trial results on ClinicalTrials.gov under rule FDAAA 801.
The researchers selected three metrics: disclosure timing; the extent to which stated research objectives are modified in published results; and the use of positively toned scientific publications as references.
“These disclosure elements are crucial because they can potentially undermine the regulatory goals of enhancing transparency and public welfare,” the authors wrote.
Results
The key findings are that while, on average, competitive pressure shortens disclosure time, it also prompts more editing and increases the likelihood sponsors will preferentially cite research that supports their findings.
“The role of competition is twofold. Increased competition is associated with more timely disclosures: a one standard deviation rise in competition is associated with a 47-day decrease in the time to disclose.
“However,” the authors continued, “under intense competitive pressure, firms change the text of pre-defined research objectives even after a study is completed with results. … In addition, under intense competition, firms support their mandatory disclosures with scientific papers that have a more positive tone.”
FDAAA 801 initiative implications
The implication is that, even under transparency rules mandating the sharing of standardized information about clinical trials, drug companies will adjust their disclosures in the presence of high competition.
“The dual role of competition is particularly noteworthy, indicating a nuanced trade-off: while disclosing faster, firms remain cautious in controlling the content of their disclosure,” the authors wrote.
Likewise, the discovery that competition prompts drug firms to edit disclosures – by, for example, adding new primary outcomes, modifying timings, altering the measurement approach – is also a concern, according to the authors.
“All these are considered problematic ‘outcome switching’ practices in the medical field,” the authors wrote, adding, “Our research has implications for regulators and policymakers, particularly those behind the FDAAA 801 initiative.
“While the platform allows for tracking changes made to disclosure texts, it should also enable more precise quantification of the significance of these changes, especially those made after results are posted.”
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