The Institute for Quality and Efficiency in Health Care (IQWiG) is calling on the German government to push for an EU regulation making it mandatory for sponsors to register and publish the results of all of their clinical trials, including negative ones.
The institute’s move follows a disagreement with Pfizer concerning unpublished study data about the company’s antidepressant reboxetine. The IQWiG claims the process was “greatly hindered” by Pfizer, which took a “long time” to make available trial data on reboxetine. The institute claimed that data were available for only 1,600 of 5,100 of the patients in 17 clinical trials.
“By concealing available study data, the manufacturer is depriving patients and doctors of the opportunity to make an informed decision on different therapy options,” said Peter Sawicki, director of the IQWiG.
That negative trial results often go unpublished has been known for many years. “Deception through concealment is no trivial offence,” said Sawicki. “In extreme cases, patients may even receive useless or harmful treatments if information is incomplete.”
For example, in the treatment of depression other researchers have already shown that the effect of several agents has been overestimated in the published literature—up to 70% (on average about 30%), according to IQWiG. In the case of some drugs, it is even doubtful whether a benefit is detectable at all, if all trials are considered.
In an effort to solve the problem, IQWiG concluded a basic agreement on the transfer of such data with the German Association of Research-based Pharmaceutical Companies by 2005. IQWiG’s aim is to draw reliable conclusions concerning the benefit and harm of drugs. These provide the Federal Joint Committee (G-BA) with a scientific basis for its decisions on reimbursement of drugs.
In January 2005 the international associations of the pharmaceutical industry announced a voluntary commitment to disclose information on clinical trials. In recent years, companies have repeatedly refused to provide the IQWiG with study documents required for the benefit assessment of drugs. Frequently, clinical trial registries, which have been set up in recent years, do not contain these data either, the group said.
IQWiG’s experience has shown that the existing measures, which are primarily based on voluntary solutions in Germany and Europe, are inadequate. So IQWiG is calling for an EU-wide legal obligation, bound by tight deadlines, for sponsors to publish the results of clinical trials.
“In the USA this obligation has been clearly implemented by law since 2008,” explains Sawicki. “We need a comparable, definite and transparent implementation for Europe as soon as possible.” It is essential that such an obligation must also apply retrospectively to drugs already approved, IQWiG said.
Sawicki added, “Keeping the results of a trial secret is cheating the participating patients and questions the legitimacy of their consent to participate in trials.”