Saturday, July 12, 2014

Clinical Trial Registries in US, EU, WHO, China, and other countries

For the past decade, there was increasing pressure on pharmaceutical companies to be transparent on the clinical trials and the clinical trials results. It is considered not a good practice if the pharmaceutical companies publish only the clinical trial with positive results and hide the clinical trial with negative results.

On September 27, 2007, the President George W Bush signed U.S. Public Law 110-85. The law includes a section on clinical trial databases (Title VIII) that expands the types of clinical trials that must be registered in ClinicalTrials.gov, increases the number of data elements that must be submitted, and also requires submission of certain results data.

After the law is enacted, the clinical trial registries have blossomed. In US, all clinical trials are required to be registered in clinicaltrials.gov database.

In the early stage, some companies used a perfunctory way in compliant with the registries and provided very little or meaningless information on the clinical trial registries. For example, one of the clinical trial entry listed Primary Outcome Measures ‘Efficacy’; Secondary Outcome Measures ‘Safety’ instead of providing what the outcomes are.

With the time, the companies are now more serious about the clinical trial registries. For those companies who are not compliant with clinical trial registries, there are penalties.
“FDAAA 801 establishes penalties for Responsible Parties who fail to comply with registration or results submission requirements. Penalties include civil monetary penalties and, for federally funded studies, the withholding of grant funds.

See the statutory provisions amending Civil Money Penalties (PDF) and Clinical Trials Supported by Grants From Federal Agencies (PDF). “
More importantly, the clinical trial registration is now becoming a requirement for the publication. For medical journal, it will be difficult to get clinical trial results published if the study is not registered at the time of the clinical trial start. International Committee of Medical Journal Editors (ICMJE) indicated that the following registries are acceptable
ICMJE also stated:
“In addition to the above registries, starting in June 2007 the ICMJE will also accept registration in any of the primary registries that participate in the WHO International Clinical Trials Portal (see http://www.who.int/ictrp/network/primary/en/index.html). Because it is critical that trial registries are independent of for-profit interests, the ICMJE policy requires registration in a WHO primary registry rather than solely in an associate registry, since for-profit entities manage some associate registries. Trial registration with missing or uninformative fields for the minimum data elements is inadequate even if the registration is in an acceptable registry.”
The same clinical trial may be registered in multiple clinical trial databases, but is not required to be registered in multiple clinical trials databases. In reality, we often found that the same clinical trials are registered in multiple places and the data entries are for the same trial are actually different in different registries.

In 2013, SFDA of China issued the regulation '关于药物临床试验信息平台的公' requiring the clinical trial registration at http://www.chinadrugtrials.org.cn/ on its platform at www.cde.org.cn.

1 comment:

Anonymous said...

There is also a clinical trial registry used in EU:

Current Controlled Trials
http://www.controlled-trials.com/

The explanation of this registry can be found at:

http://www.controlled-trials.com/information/faqs.asp