EU should require all trials to be registered, says IQWiG
pharmafile | December 1, 2009 | News story | Sales and Marketing | Germany, IQWIG, health economics, hta
Germany’s Institute for Quality and Efficiency in Health Care (IQWiG) has said that registration and publication of all clinical trials should be made obligatory in the European Union to bring the region closer into line with the US.
The health technology assessment agency’s director Peter Sawicki said that the current situation allows trial sponsors to conceal study results, “depriving patients and doctors of the opportunity to make an informed decision on different therapy options”.
IQWiG, the German equivalent of the UK’s National Institute for Clinical Excellence (NICE), said it had been forced to issue the call in the wake of difficulties it had reviewing three antidepressants – Pfizer’s Edronax (reboxetine), Essex Pharma’s MirtaLich (mirtazapine) and GlaxoSmithKline’s Wellbutrin XL (bupropion).
The HTA says its review was “greatly hindered” by Pfizer because “for a long time, the manufacturer refused to make information on trials available”.
“Only when put under public pressure did Pfizer finally disclose the data,” said IQWiG, which claims that Pfizer had been concealing almost two-thirds of all data in the trials.
The agency has also published the results of its review of the three antidepressants, concluding that there is no scientific proof that people suffering from depression can benefit from taking Edronax, although it said MirtaLich and Wellbutrin XL can alleviate symptoms.
It also says there was “proof of harm” for Edronax, as patients discontinued treatment more frequently due to adverse side effects compared to those on placebo or generic antidepressant fluoxetine (Lilly’s now off-patent drug Prozac).
Essex Pharma also did not escape criticism. IQWiG said it had to add an explanatory note to its preliminary report on the review process in June, saying that data withheld on MirtaLich might bias its conclusions. That caveat has now been removed from the review document.
Since 2008, registration on the US National Institutes of Health’s www.clinicaltrials.gov database has been mandatory for phase II-IV controlled clinical trials of US Food and Drug Administration-regulated drugs, biologics, and devices.
IQWiG wants to see similar requirements in place for trials carried out in Europe.
“The German Federal Government must push for a mandatory regulation to be implemented at EU level,” said the HTA in a statement.
Earlier this month the International Federation of Pharmaceutical Manufacturers & Associations drew up a new code of conduct indicating that drugmakers should disclose every clinical trial they undertake.
However, IQWiG says its experience shows that voluntary approaches to disclosure are inadequate.
“We need a … definite and transparent implementation for Europe as soon as possible,” said Sawicki. The approach should be EU-wide, legally-binding and subject to tight deadlines, he added.
“It is essential that such an obligation must also apply retrospectively to drugs already approved,” said Sawicki.
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