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IQWiG: Key data missing from public trial reports

German HTA body claims drug studies published in journals contain ”insufficient information"

German HTA body IQWiG 

Drug trial reports made available to the public often lack vital study details, according to the organisation that assesses the cost-effectiveness of new medicines in Germany.

In a study published in PLOS Medicine, Germany's IQWiG said that trials reported in journals or registry reports can miss information about the effects and side effects of medicines which feature in the full clinical study reports (CSRs) produced by pharma companies.

IQWiG's study analysed a sample of 101 trials with full CSRs it received for 16 assessments of drugs between 2006 and 2011.

These CSRs include 1,000 patient-relevant outcomes split into two categories: benefits, such as improving mortality rates and disease symptoms, and harm, such as adverse events.

The study compared these CSRs to publicly available sources containing details of these trials, assessing the completeness of information on all patient-relevant outcomes included in IQWiG's HTA.

Of the 101 trials assessed, 86 had at least one publicly available source, 65 at least one journal publication, and 50 a registry report.

According to IQWiG's study, 86 per cent of the CSRs analysed provided complete information on patient outcomes, compared to just 39 per cent of studies published in publicly available sources.

For the benefit outcomes, CSRs provided complete information on 78 per cent to 100 per cent of the various types of outcome, while publicly available study reports ranged from 20 per cent to 53 per cent.

CSRs also provided “considerably more information” on the adverse events in trials, according to the study, which was led by Beate Wieseler, head of IQWiG's drug assessment department.

IQWiG used the findings of the study to back the growing call for CSRs to be made available to the public.

“The publicly available journal articles and registry entries thus report less than half of outcomes of clinical trials comprehensively,” said Wieseler. “At the same time, CSRs documents are available that provide complete information on methods and outcomes.

“The consequence can only be: all CSRs must be made publicly accessible.”

IQWiG has already made public its view that there should be great transparency for CSR data, signing up to the AllTrials campaign to make pharma companies publish all patient-level trial data.

The German body also announced last week that it backs the European Medicines Agency's (EMA) proposed policy to make clinical trial available to suitable researchers on a tiered basis.

But more can still be done, over and above the EMA's plans, according to Wieseler.

“A central repository is required, also including data from older trials, as such trials investigate drugs widely used in current medical practice, ” she said.

“This data would probably shed a totally new light on several drugs and their position in their therapeutic area.”

Article by
Thomas Meek

10th October 2013

From: Research, Regulatory



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