Published Clinical Trials Lack Significant Data
A study conducted by members of Germany’s Institut für Qualität und Wirtschaftlichkeit im Gesundheitswesenis (Institute for Quality and Efficiency in Healthcare) or IQWiG has found that clinical trial information that is made available to the public contains less than half of the patient-relative data reported in unpublished Clinical Study Reports (CSRs).
About the IQWiG Clinical Trial Study
According to MedScape, the study analyzed 101 clinical trials in which the IQWiG had previously requested and received full Clinical Study Reports.
The findings reported in the CSRs were then compared to those published in medical journals, specifically data concerning the benefits and adverse events related to the drugs.
Findings of the IQWiG Clinical Trial Study
“In contrast to CSRs, publicly available sources provide insufficient information on patient-relative outcomes of clinical trials. CSRs should therefore be made publicly available.” – Beate Wieselar, PhD, IQWiG’s Drug Assessment Department in MedScape.
Upon reviewing the CSRs and journal publications, the German regulatory agency found that the information presented to the public lacked significant data.
- Only 39 percent of publicly available sources included complete information on patient outcomes including the benefits and adverse events correlated to the drug being studied.
- Comparatively 86 percent of the unpublished records and CSRs obtained by the IQWiG contained complete information on patient outcomes.
- Some public sources reported as little as 27 percent of complete information pertaining to the adverse events that were recorded during clinical trials – no single public source contained more than 72 percent of the complete adverse event information.
Researchers involved in the study contend that these numbers are further evidence of the need to make all Clinical Study Reports publicly available.
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