The AllTrials campaign, striving to achieve full disclosure of all results in clinical trials, recently conducted an audit of the transparency policies of pharmaceutical companies, finding them open enough on the surface — but beset with devils in the details.

Researchers scrutinized the trial registration and reporting policies of major pharmaceutical companies worldwide in what is apparently the first such attempt to systematically examine drug company policies on trial transparency. It is something of an understatement to say the results were mixed, with gains in transparency in one area offset by impenetrable policies in another.

They found that most large companies have some manner of publicly stated policy about registering and reporting results from current trials. However, only around half of the company policies examined revealed results from past trials, said Ben Goldacre, lead author and co-founder of AllTrials, in a podcast interview with BMJ.1

“It’s very clear that we need the results trails from much further back,” Goldacre said. “We also found for the commitments on sharing individual patient data and clinical study reports — which are much more detailed sources of information about clinical trials — the average start date for those only 2012. So again, that is hopelessly recent.”

In addition, many pharmaceutical companies were reticent to share data from trials on off-label uses of drugs, either for unlicensed treatments or unlicensed uses of drugs for licensed treatments, he said.

“That is very problematic,” Goldacre said. “We know the off-label uses are very common, and are often warranted and are clinically reasonable. The methods and results of clinical trials on unapproved treatments can be very important. The history of medicine is littered with examples where there have been problems with a whole class of treatments, which were apparent, with drugs that were members of that class that were never approved. And because those drugs were never approved, the trials were never shared, though they may have given an early warning of trouble ahead.”

The investigation was conducted between April 2015 and April 2016. Just over half of the companies engaged, including 11 out of 50 who said they would make some changes to their published policies because they did not reflect practice, or to clarify the issues raised.

In general, the drug company transparency policies often were vague and ambiguously worded, internally contradictory, or difficult to interpret, the authors found.

“We found policies that contained ambiguous language and problematical contradictory use of the term ‘all’ as in ‘all trials,’” Goldacre said. “These were not just poorly defined caveats of the policies but also inconsistencies within documents, multiple documents describing one company’s policy that had inconsistencies between them. We found examples of companies that had different policies for different reasons.”

The authors recommended that pharmaceutical companies should draft clear, simple statements on drug trial information that they will or will not share. As a model, the paper includes a boilerplate transparency policy that can be used and modified.

REFERENCE

  1. Goldacre B, Lane S, Mahtani KR. Pharmaceutical companies’ policies on access to trial data, results, and methods: audit study. BMJ 2017; 358 doi: https://doi.org/10.1136/bmj.j3334.