There are 15 clinical trial registries that conform to the WHO Primary Registries, including ClinicalTrials.gov, and over 50 specialty registries in the United States (US) alone. That is more than 65 possible places to disclose your clinical trial. How can you narrow the list of possibilities to determine where you should disclose your trial? Here are a few helpful considerations when determining your approach to clinical trial disclosure.
Where are the trial sites?
The most obvious and relevant place to start is where the trial is being conducted. Many countries have requirements to register studies and possibly to disclose results when trials are conducted in the country. Some independent ethics committees and review boards require trial registration as part of the ethical approval of a trial.
Where will the product be approved or marketed?
If you want to market a product in a specific country, you need to understand the registration requirements of that country. Some countries require clinical trial disclosure as part of the approval or marketing authorization process. This may include the registration of studies used to support a marketing approval or authorization in country or region, such as studies that are included in a Paediatric Investigation Plan (PIP) in the European Union (EU), or that are required by local authorities as part of a post market surveillance.
Where is the study product manufactured?
This may be surprising, but the manufacturing location of the study product can affect disclosure requirements. For example, the United States requires clinical trial disclosure if the product used in the trial was manufactured in the US and exported for research, even if there are no trial sites located in the US.
Do you want to publish?
On the off-chance that the above factors don’t require trial registration on a WHO Primary Registry or on ClinicalTrials.gov, you may need to consider posting the study to one of these registries. The International Committee of Medical Journal Editors (ICMJE) requires that studies are registered by first patient enrollment in one of these registries. There is a long list of journals that follows the ICMJE recommendations, and they are required to verify registration as a condition of publication. As an aside, some journals have required an NCT # that is provided by ClinicalTrials.gov as a prerequisite for publication. Please check with the individual publication to understand their specific requirements for clinical trial registration.
What condition are you studying?
There are many specialty registries that provide trial information to specific interest groups. Organizations and researchers may desire, or be required, to register studies with one or more of these specialty registries.