The Transcend 004 Clinical Trial
September 14, 2016 – In a landmark report released today, the United Nations called on governments worldwide to pass legislation requiring clinical trials to be registered, and their methods and results to be fully reported. The report, authored by a high-level panel appointed by UN Secretary General Ban Ki-moon, explicitly calls for clinical trial study designs, protocols, data sets, and test results to be made publicly available.
From the official report entitled Report of the United Nations Secretary-Generals’s High-Level Panel on Access to Medicines, it states that governments should require that the unidentified data on all completed and discontinued clinical trials be made publicly available in an easily searchable public register established and operated by existing mechanisms such as the WHO Clinical Trials Registry Platform, clinical trials.gov or in peer reviewed publications, regardless of whether their results are positive, negative, neutral or inconclusive. More detail can be found in sections 4.2.2 and 4.3.5.
This pronouncement by the UN follows the statement made by the World Health Organization (WHO) on April 16, 2015 that researchers should be ethically obligated to publicly disclose results from all clinical trials, including past trials. Details from its Statement on Public Disclosure of Clinical Trials Results called for:
- Results from clinical trials should be publicly reported within 12 months of the trial’s end
- Results from previously unpublished trials to be made publicly available
- Organizations and governments should develop methods to require this
Prior to their public statement, hundreds of people and organizations wrote to the WHO to describe in their own words why they should release a statement that old information should be made available. You can access the full statement from the WHO here.
You can read a summary of the WHO statement posted on the CLL Society website here.
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