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Papers don’t tell the whole story
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PolicyGermanyEU

Papers don’t tell the whole story

09.10.2013 - According to a new study, clinical trial outcomes are more complete in unpublished reports than in publicly available information.

Publicly available sources of information that report findings from clinical trials provide much less information on patient-relevant outcomes than unpublished reports, states a study published by German researchers. The results of the study by Beate Wieseler and colleagues from the Institute for Quality and Efficiency in Health Care (IQWIG) in Cologne found that the publicly available information contained less information about both the benefits and potential harms of an intervention than the unpublished report. Their findings highlight the importance of recent initiatives, such as the AllTrials initiative that aims to make clinical trial outcome data publicly available, in order to provide complete and transparent information to help patients and clinicians reach decisions about clinical care.

In the study, the researchers compared the information available in clinical study reports, which are detailed but usually unpublished accounts of clinical trials, to publicly available sources, including journal publications and registry reports. They found that unpublished reports included complete information for 86% of the patient-relevant outcomes, whereas the combined publicly available sources provided complete information for only 39% of the outcomes. Although the trials included in this study may not be representative of all trials, the findings support a draft policy released in June 2013 by the European Medicines Agency calling for the routine publication of complete clinical trial data.

The authors say: "Our findings show that a substantial amount of information on patient-relevant outcomes required for unbiased trial evaluation is missing from the public record. [Clinical study reports] should be made publicly available as they may substantially influence conclusions concerning the actual position of an individual drug in a therapeutic area."

The study is just another piece in the ongoing debate on transparency of clinical trials set to be implemented in the new EU clinical trials regulation. The pharma industry has stated its will to share clinical data of approved drugs but has also pointed out that it would be essential to exclude any use or misuse of personal data, i.e. when it comes to trials on orphan drugs. In May, the General Court of the European Union ordered the EMA not to provide any raw data on pivotal clinical trials of EU-approved drugs to competitors of originator drugs' developers.

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No liability assumed, Date: 19.04.2014