Regulatory Focus™ > News Articles > IQWiG Finds Important Information Missing in Most Publications, Calls for CSR Disclosures

IQWiG Finds Important Information Missing in Most Publications, Calls for CSR Disclosures

Posted 10 October 2013 | By

In a study of health technology assessment reports on drugs completed by Germany's Institute for Quality and Efficiency in Healthcare (IQWiG) between 2006 and 2011, the assessment agency found that trials reported in journals or registry reports often miss information about the effects and side effects of medicines which feature in the full clinical study reports (CSRs) produced by pharma companies.

The study, published in PLOS Medicine, analyzed data from a sample of 101 trials with full CSRs received by IQWiG for 16 assessments of drugs. 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.

Of the 101 trials assessed, 86 had at least one publicly available source, 65 at least one journal publication, and 50 a registry report. IQWiG found that 86% of the CSRs studied provided complete information on patient outcomes, compared to just 39% of the studies published in publicly available sources. Negative effects on patients ("harm outcomes") such as serious adverse events or treatment discontinuations were reported far less often in the publicly available sources (27% to 72% versus 84% to 92%, depending on the harm outcome investigated).

IQWiG: Make all CSRs Public

Beate Wieseler, chief of IQWiG's drug assessment department, headed the study.  "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."

Last week the German body also announced its support for the European Medicines Agency's (EMA) proposed policy to make clinical trial data available to researchers on a tiered basis.

PLoS Study

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Tags: IQWiG, Germany

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