The International Clinical Trials Registry Platform (ICTRP) was created in 2006 by the World Health Organization (WHO) and gives health professionals a comprehensive overview of medical research that is being undertaken around the world. The registry aims to improve research transparency and strengthen the validity and value of the scientific evidence base. According to WHO “the registration of all interventional trials is a scientific, ethical and moral responsibility.”
The ICTRP first started with the three registries known as the ISRCTN (UK), the ANZCTR (Australia and New Zealand) and clinicaltrials.gov (USA). They currently have 17 international primary registries which all meet the standards set by the WHO. These criterias revolve around content, quality and validity, accessibility, unambiguous identification, technical capacity, and administration and governance.
The ICTRP search portal was developed to make it easier to find certain clinical trials. It currently has over 600,000 records and is updated every week.
What are Trial Registrations?
A trial registration is a public record of planned international clinical trials which outlines the design, conduct and administration of each study. Every registration has to adhere to an internationally-agreed set of information and is published on an accessible website which is managed by a registry and operates in accordance with the World Health Organization standards.
Why are Trial Registrations Important?
According to The Declaration of Helsinki: “Every clinical trial must be registered in a publicly accessible database before recruitment of the first subject.”
The registration of clinical trials is so important because:
It removes the risk of:
- Publication Bias: When the likelihood of a study being published is impacted by its findings.
- Selective Reporting: When the results from a clinical trial are not accurately reported due to unsatisfactory results.
- Decisions about health care have to be made with full knowledge of all the available evidence.
- It makes it easier for researchers and CRO companies to avoid any duplication of clinical trials.
- It identifies gaps in medical research.
- It promotes clinical trials to potential participants.
- Researchers and medical professionals can find clinical trials that they’re interested in which can result in more effective collaboration.
- It can improve the quality of clinical trials by identifying potential issues that may arise early on in the research process.
- It improves research transparency.
- It strengthens the value of the scientific evidence.
How Do You Register a Clinical Trial?
To register a trial, you have to submit the relevant details to any Primary Registry listed on the WHO Registry Network or an approved registry through the International Committee of Medical Journal Editors (ICMJE).
The regulatory, legal, ethical and funding requirements for each clinical trial differs from country to country. The ICTRP works with only one registry from each member state, and it is up to each member state to decide on a national registry.
The ICTRP have collaborated with several organisations to ensure that the data collected from the registry can be utilised in different ways and tailored to fit certain needs. They collaborate with the following organisations:
- The WHO e-Library of Evidence for Nutrition Actions (eLENA): An online library guidelines for research and trials involving nutrition which includes evidence based knowledge.
- The Swiss National Portal of Clinical Trials (KOFAM): The Swiss Federal Office of Public Health’s (FOPH) portal for human research in Switzerland.
- The Human Genome Editing (HGE) Registry: A central database which collects information about the use of human genome editing technologies in clinical trials.
- The Orphanet Rare Diseases Platform: A resource which provides curated and expert-validated knowledge on rare diseases.
The Universal Trial Number (UTN)
The UTN is not a registration number but is used to identify the clinical trials which are registered with one of WHO’s primary registries and displayed on the International Clinical Trials Registry Platform’s (ICTRP) search portal.
The UTN should:
- Be attached to a clinical trial and become part of its identity.
- Be used whenever the clinical trial is talked about.
- Be documented in the clinical trial protocol.
- Be submitted every time the trial is registered.