Why is Trial Registration Important?
The registration of all interventional trials is considered to be a scientific, ethical and moral responsibility because:
- There is a need to ensure that decisions about health care are informed by all of the available evidence
- It is difficult to make informed decisions if publication bias and selective reporting are present
- The Declaration of Helsinki states that "Every clinical trial must be registered in a publicly accessible database before recruitment of the first subject".
- Improving awareness of similar or identical trials will make it possible for researchers and funding agencies to avoid unnecessary duplication
- Describing clinical trials in progress can make it easier to identify gaps in clinical trials research
- Making researchers and potential participants aware of recruiting trials may facilitate recruitment
- Enabling researchers and health care practitioners to identify trials in which they may have an interest could result in more effective collaboration among researchers. The type of collaboration may include prospective meta-analysis
- Registries checking data as part of the registration process may lead to improvements in the quality of clinical trials by making it possible to identify potential problems (such as problematic randomization methods) early in the research process.
How to Register a Trial?
You cannot register a trial with WHO. The WHO ICTRP is not a clinical trials registry.
To register a trial, submit the details directly to any one of the Primary Registries in the WHO Registry Network or an ICMJE approved registry.
To meet the requirements of the International Committee of Medical Journal Editors (ICMJE) you can register your trial with any Primary Registry in the WHO Registry Network or an ICMJE approved registry.
To meet WHO requirements for transparency and publication, it is only necessary for your trial to be registered once, in either a Primary Registry in the WHO Registry Network or an ICMJE approved registry.
NOTE: Regulatory, legal, ethical, funding and other requirements for oversight and conduct of clinical trials differ from country to country. It is recommended that those responsible for conducting a clinical trial check to make sure they are complying with the specific requirements of each country.
Organizations with Policies
The organizations listed below have policies on clinical trial registration. If you know of an organization that could be added to this list, please contact us.
Codes of Research Practice
Funders
Ethics Committees
Legal Requirement
National Research Ethics Oversight Agencies
Professional Organizations
Publishers
Universities
Source: WHO