A Canadian research team has warned that some pharma companies continue to prevent clinical trial results from being made public.
According to a new study:
“A few investigators [we interviewed] described trials which showed harms or safety concerns and were not published, including a Phase I trial that was completed and Phase III trials that were stopped early.”
“The harms of incomplete trial reporting have been documented related to several types of drug therapy, including the antibody TGN1412, antiarrhythmic drugs, and the type 2 diabetes drug rosiglitazone… In some cases, internal company documents have revealed the intention to suppress unfavorable results.”
One informant told them that:
“Sometimes with these trials you're also signing confidentiality agreements . . . and that prevents you, as an investigator, banging out an article kind of in violation of your confidentiality agreement. I know that's happened, where there was some investigator who felt that a particular drug or a device . . . was harmful, and that information is being suppressed by the trial sponsor, so they write a paper that ends up in lawsuits and all kinds of things.”
The research team warned that:
“Canada lacks... regulatory requirements for reporting of clinical trial results. It is important for reporting rules to cover all clinical trials of drugs and biologics and for Canada to adopt regulatory measures to make reporting of clinical trial results mandatory.”
“Health Canada and research institutions in Canada have an obligation to ensure that site investigators are able to report trial findings based on all data from multisite trials, when sponsors and trial leaders do not proceed with timely reporting.”
The World Health Organization recommends that “Legislation or supporting regulations [should include] sanctions if a clinical trial is not registered and/or results are not reported.”
The WHO has long demanded that the results of all interventional clinical trials be made public on a registry within 12 months of trial completion.
The Canadian study identified seven key themes related to industry influence on clinical trial reporting:
Sponsor influence on decision-making about whether to publish
Weaker incentives to publish trials with negative findings or evidence of harm
Stopping trials early and not reporting stopped trials
Ownership and control of data
Clinical trial agreements and confidentiality restrictions
Nonpublication of internal company trials
Dependency on funding from industry-sponsored trials
The study is based on interviews with 34 Canadian clinical trial investigators, trial participants, and other experts. The study can be accessed here.
“The influence of pharmaceutical companies on data reporting, combined with the often seeming complacency of scientific journals to publish negative studies, have blurred the boundaries between fact and a biased interpretation of the facts.”
“We encourage the submission of negative studies from well-designed clinical trials… All published clinical trials are currently, and will remain, mandated to be reported in national or international registries for consideration of review.”