Approximately 90 countries have requirements related to the disclosure of clinical trial data made publicly available on over 30 clinical trial registries, but enforcement of clinical trial disclosure requirements varies greatly, an industry white paper has found.
The report summarises current laws and enforcement mechanisms in numerous countries worldwide, covering the Americas, Asia, Europe, and Oceania.
Below extracts from the report about three major countries that often receive little attention from regulatory scientists writing in English: China, India, and Japan.
According to the report:
The Chinese Clinical Trial Registry (ChiCTR) is a WHO International Clinical Trials Registry Platform (ICTRP) primary registry. As per its guidelines, after the completion of a trial, the statistical results should be uploaded to ResMan, a public management platform for clinical trials, and the results should be published one year later.
National regulations state that:
“The sponsor shall register the drug clinical trial protocol and other information on the drug clinical trial registration and information disclosure platform before carrying out the drug clinical trial. During the drug clinical trial, the sponsor should continuously update the registration information, and register the drug clinical trial results and other information after the drug clinical trial is completed. The registration information is publicized on the platform, and the sponsor is responsible for the authenticity of the drug clinical trial registration information.”
Sponsors failing to register a drug trial or report its results “shall be ordered to make corrections within a specified time limit” or face a fine.
Prospective registration on the Indian trial registry CTRI is mandatory per the ‘New Drugs and Clinical Trials Rules’ but India does not have laws that cover results disclosure.
The report states that in Japan:
A trial should be registered before the first subject is enrolled, and the results should be registered within one year after the completion of the clinical trial, unless it conflicts with the laws and regulations of other countries or if it interferes with publication in peer-reviewed medical journals.
Call for more regulatory clarity
The report concludes that:
“Interpretation of penalties as defined in legislation is difficult. In many cases, it is unclear whether regulations strictly apply to disclosure activities (registration in a publicly accessible registry and results dissemination) or more specifically to the direct interaction with authorities and clinical trial authorization requirements, which are often distinct processes.”
“Management of clinical trial disclosure is a complicated endeavor, and regulatory agencies should take steps to make compliance as easy as possible — and to enforce strict penalties for noncompliance.”
The white paper was produced by Citeline, a pharma business intelligence company that offers clinical trial disclosure services. The document can be accessed here. TranspariMED's founder Till Bruckner was interviewed for the report, but did not receive any payment. TranspariMED does not take industry funding.