Following the policy of the International Committee of Medical Journal Editors (ICMJE) in 2004 on trial registration, a series of international organizations and some countries came up with related policies and laws mandating the registration of any publicly and privately supported clinical trials conducted in patients. [see ClinicalTrials.gov; WHO ICTRP] Trial registration involves the submission of descriptive information (i.e. study protocol including the design, recruitment information, eligibility criteria, conduct, and administrative elements of a clinical trial) about a prospective clinical trial to a web-based registry that is readily accessible to the public. Trial registration must be done before recruitment of first patient. In addition, updates on the study protocol and summary of results throughout the trial lifecycle are expected to be provided on a timely basis.
- Provides information for potential participants, researchers and referring clinicians about ongoing clinical trials. This may help trial recruitment.
- Prevents duplication of trials
- It helps identify potential design problems (for example, problematic randomization methods may be identified by the registry at review) early in the research process, thus improving the quality of clinical trials and clinical research practice.
- It ensures transparency, helping to avoid selective reporting and publication bias.
- It increases the efficiency of drug and device development processes.
- It is required by ICMJE for journal publication of research results generated by a clinical trial.
- It is an ethical obligation required of the primary sponsor or principal investigator conducting a clinical trial by law. The Declaration of Helsinki states that “Every clinical trial must be registered in a publicly accessible database before recruitment of the first subject”.
According to ICMJE policy, a trial registry must:
- be electronically searchable
- be easily accessible to prospective registrants and the public at no cost
- have a mechanism in place that ensures that the registration data are valid
- be managed by a not for profit organization
- contain a minimum set of structured information (24-item trial registration data set [see WHO; ClinicalTrials.gov]) about all ongoing and completed trials at the time of registration or before recruitment of the first participant
- facilitate reporting of results (whether directly or via linking to publications)
- facilitate data sharing
Registrations that are not made publicly accessible, typically phase I trials submitted to the European Clinical trial Registries (EU-CTR) and trials of devices for which the information is placed in a “locked box” are not acceptable by ICMJE policy. Such trials are not acceptable for publication unless moved to a public registry prior to recruitment of the first participant.
ICMJE also expects authors to document and meet all the results reporting requirements of their funding and regulatory agencies. If there are no such reporting requirements, the ICMJE encourages authors to submit results information to the same database on which their trials are registered.
When registering a trial investigators must now provide a data sharing statement. Data sharing statements must indicate: “what data in particular will be shared; whether individual de-identified participant data (IDP), including data dictionaries will be shared (“undecided” is not an acceptable answer); whether additional, related documents will be available (e.g., study protocol, statistical analysis plan, etc.); when the data will become available and for how long; by what access criteria data will be shared (including with whom, for what types of analyses, and by what mechanism)” . [see ICMJE statement on data sharing]
ClinicalTrials.gov [US National Institutes of Health (NIH)] is also acceptable to ICMJE and is widely used.
Note: ICMJE no longer review registries for acceptability. Registrants should consult the WHO ICTRP. Any registry designated by WHO as “primary registries” will be acceptable to the ICMJE.
For multinational, multicenter trials involving participants from more than one institution or country, the trial may need to be registered in more than one registry depending on the policies and law guiding trial registration in that institution or country. For example in India, multi‑country trials registered in an international registry, is also expected to be registered in the Clinical Trial Registry – India (CTRI) if India is a participating country [a WHO Primary Regsitry].
- Before registering your trial, obtain a Universal Trial Number (UTN).
While not essential, we recommend this step (in line with WHO guidance). It is particularly important for multinational, multicenter trials involving more than one institution or country may have to be registered in more than one registry and so have more than one trial identifying number. The UTN is a unique identifying number that enables one to link multiple records on the same trial together on the ICTRP search portal. A trial should have only one UTN, irrespective of the number of centers participating in the study. This number becomes permanently attached to the trial and should be submitted at the time of trial registration. A UTN can also be obtained retrospectively (after trial registration). In this case, the coordinating center should update all records within primary registries and all other documentation linked to the trial to reflect the UTN. Get your UTN here
- Find out who should be responsible for trial registration and reporting, and the Trial Registry to be used.
For most registries, it is the primary sponsor or the principal/lead investigator delegated by the sponsor, grantee, contractor, or awardee of the research that is usually responsible for the trial registration. [see here for US NIH definitions of ‘responsible party’] Most sponsoring organizations have policies guiding trial registration and in many cases they may have preference for a particular registry depending on the institution or the country where the sponsors are located. Regulatory, legal, ethical, funding and other requirements for oversight and conduct of clinical trials differ between organizations and countries. It is important that those responsible for the conducting the trial comply with the requirements of the country or organization sponsoring the trial. For example all National institutes of Health (NIH)-funded clinical trials are expected to be registered in Clinicaltrials.gov.
- Apply for a user account with the chosen Registry To register study information into any registry database, you need to apply for a user account. Most sponsors / organizations (such as a company, university, or medical center) operates just one account. Each organization usually assigns one or more Administrators whose job is to manage the account and create logins for all principal investigators conducting clinical trials within the organization.
- Learn about submission requirements of the chosen registry: This is found on the registry’s website
- Login to the account.
- Enter the required and optional trial data set elements as required by the registry.
- Preview and submit the record. Once a trial is submitted, it cannot be withdrawn.
- After registration, the trial status is expected to be updated regularly and available for public display.