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For the purposes of registration, a clinical trial is any research study that prospectively assigns human participants or groups of humans to one or more health-related interventions to evaluate the effects on health outcomes. Clinical trials may also be referred to as interventional trials. Interventions include but are not restricted to drugs, cells and other biological products, surgical procedures, radiologic procedures, devices, behavioural treatments, process-of-care changes, preventive care, etc. This definition includes Phase I to Phase IV trials.
What is trial registration?
WHO regards trial registration as the publication of an internationally-agreed set of information about the design, conduct and administration of clinical trials. These details are published on a publicly-accessible website managed by a registry conforming to WHO standards.
ClinicalTrials.gov is a Web-based resource that provides patients, their family members, health care professionals, researchers, and the public with easy access to information on publicly and privately supported clinical studies on a wide range of diseases and conditions. The Web site is maintained by the National Library of Medicine (NLM) at the National Institutes of Health (NIH). Information on ClinicalTrials.gov is provided and updated by the sponsor or principal investigator of the clinical study. Studies are generally submitted to the Web site (that is, registered) when they begin, and the information on the site is updated throughout the study. In some cases, results of the study are submitted after the study ends. This Web site and database of clinical studies is commonly referred to as a "registry and results database."
Open Trials, an open, online database of information about the world’s clinical research trials. We are funded by The Laura and John Arnold Foundation through the Center for Open Science. The project, which is designed to increase transparency and improve access to research, will be directed by Dr. Ben Goldacre, an internationally known leader on clinical transparency.
OpenTrials is building a collaborative and open linked database for all available structured data and documents on all clinical trials, threaded together by individual trial. With a versatile and expandable data schema, it is initially designed to host and match the following documents and data for each trial:
Links, abstracts, or texts of academic journal papers
Portions of regulatory documents describing individual trials
Structured data on methods and results extracted by systematic reviewers or other
Clinical Study Reports
Additional documents such as blank consent forms, blank case report forms, and protocols
WHO International Clinical Trials Registry Platform (ICTRP)
The mission of the WHO International Clinical Trials Registry Platform is to ensure that a complete view of research is accessible to all those involved in health care decision making. This will improve research transparency and will ultimately strengthen the validity and value of the scientific evidence base.
The registration of all interventional trials is a scientific, ethical and moral responsibility.
The Cochrane Central Register of Controlled Trials (CENTRAL) is a highly concentrated source of reports of randomised and quasi-randomised controlled trials. The majority of CENTRAL records are taken from bibliographic databases (mainly MEDLINE and Embase), but records are also derived from other published and unpublished sources. In addition to bibliographic details (author, source, year, etc.) CENTRAL records will often include an abstract (a summary of the article). They do not contain the full text of the article.