Adequate global standards for registry reports required, say IQWiG staffers

Different formats are available for reporting the results of clinical trials. In an article just published in the British Medical Journal, employees at the German Institute for Quality and Efficiency in Health Care (IQWiG) investigated to what extent journal publications, reports posted in trial results registries, and clinical study reports submitted to regulatory authorities provide sufficient information to evaluate clinical trials. For this purpose they extracted information from benefit assessments of drugs; these assessments were finalized by IQWiG between 2006 and 2011.

The IQWiG authors found that clinical study reports submitted by manufacturers to regulatory authorities during the drug approval process provide the most complete information to evaluate a clinical trial, but such reports are in general not publicly available.

The two other formats investigated performed considerably worse. These were journal publications, which generally present study results with some delay, and registry reports (several trial registries have been established worldwide). These formats show different strengths and weaknesses. Information on study methods, such as the allocation of participants to treatment groups or the statistical analysis of data, was more complete in journal publications than in registry reports, which on the other hand provided more information on study outcomes.