Public Release: 

IQWiG welcomes WHO statement on public disclosure of clinical trial results

WHO commenting period ends -- IQWiG publishes comment

Institute for Quality and Efficiency in Health Care

The German Institute for Quality and Efficiency in Health Care (IQWiG) commented on the World Health Organization's (WHO) Statement on Public Disclosure of Clinical Trial Results; the deadline for comments was 15 November 2014. IQWiG's researchers, who rely on complete clinical trial information in their daily work, welcome the update of the WHO resolution of 2005, which at that time led to the establishment of the WHO's International Clinical Trials Registry Platform (ICTRP), a meta-search engine for clinical trials.

Many trials are still not registered, registry entries not updated, and trial results not published - despite urgent appeals and ethical obligations. For instance, in its update of the Declaration of Helsinki, the World Medical Association stated: "Every research study involving human subjects must be registered in a publicly accessible database before recruitment of the first subject" and "Researchers have a duty to make publicly available the results of their research on human subjects and are accountable for the completeness and accuracy of their reports."

Trial registries and journal publications are largely incomplete

"We fully support the fact that the WHO is now taking action against these serious information gaps", says Beate Wieseler, Head of IQWiG's Drug Assessment Department. "Like HTA agencies in other countries, in our reports we also adhere to the international standards of evidence-based medicine. For this purpose we need to be able to obtain a complete and unbiased picture of the data. The fact that a large proportion of clinical trial results has so far not been disclosed means that patients may not be receiving the best possible treatment, because we are not able to determine this treatment."

In her literature searches, Siw Waffenschmidt, Head of IQWiG's Information Management Unit, is confronted on a daily basis with the incompleteness of trial registries and published trial data: "To be able to compare the benefit of two medical interventions, we need all trial information. However, reporting in registry entries or in publications in scientific journals is often incomplete", she explains. "This particularly applies to the challenging so-called indirect comparisons, which are being increasingly examined by the Institute. We can only assess whether data from several trials are at all comparable if the methods and patient pools of the trials are precisely described. An assessment is often only possible if the clinical study reports are also available. These reports should therefore be available to all researchers."

Further demands

However, as with the new policy of the European Medicines Agency on the publication of clinical study reports, in IQWiG's opinion the WHO Statement does not go far enough. This is because the WHO demands the disclosure of trial data only from future trials. IQWiG's Director Jürgen Windeler emphasizes: "If we are commissioned to compare a new drug or medical device with already established treatments, obviously we also require the results of older trials in which these established treatments were investigated. And patients should also be able to obtain a picture of the benefits and harms of older, still commonly used drugs or medical devices."

In his opinion, the fact that the WHO calls for registration of all primary and secondary trial outcomes does not go far enough either. "We are often especially interested in other outcomes such as information on the health-related quality of life of study participants."

And finally, IQWiG is interested in knowing how the WHO will implement its demands in practice. It would make sense if trial registries wishing to be part of the WHO Registry Network via the ICTRP Search Portal were obliged to adhere to the demands outlined in the WHO Statement.

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