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RCT and Trial Registration Requirements

JMIR Editorial Team
Updated

To publish a randomized controlled trial (RCT), or randomized trial, in JMIR Publications journals, prospective registration is required. 

Features of an RCT are:

  • Conduct of a scientific (often medical) experiment that aims to evaluate the effectiveness of a new treatment or health-related intervention;
  • Random allocation of subjects to two or more groups, treating them differently, and then comparing them with respect to a measured response;
  • Study of a health-related intervention (e.g., drug, procedure, device, behavioral or educational program) which modifies a health-related outcome; and
  • Measurement of a health-related outcome, such as biomedical or health-related measures obtained from patients/participants (e.g., pharmacokinetic measures, biomarkers, adverse events).

As the ICMJE states: 

“The purpose of clinical trial registration is to prevent selective publication and selective reporting of research outcomes, to prevent unnecessary duplication of research effort, to help patients and the public know what trials are planned or ongoing into which they might want to enroll, and to help give ethics review boards considering approval of new studies a view of similar work and data relevant to the research they are considering.”

Intention to delay or not register a RCT, biased reporting, posthoc changes to the RCT protocol, or other considerations may mean a manuscript would not be eligible for peer review or publication.

 

JMIR Publications Trial Registration Requirements

When reporting primary results of an RCT, these materials or information are required with submission:

  • Trial registration number(s) from a Primary Registry or Partner Registry in the WHO Registry Network, an ICMJE approved registry, or Data Providers of the ICTRP Search Portal. This is required for publication in all JMIR Publications journals.* 
    • Trial registration must be prospective. Prospective registration requires the trial to be registered before participant recruitment begins.
    • Unregistered RCTs may require retrospective registration to be accepted for publication. Authors must explain the lack of prospective registration in the manuscript in the Methods section. Then, an Editorial Notice would note the retrospective registration to readers.
  • A figure in the Results section that is a CONSORT flow diagram of study participants.
  • An appendix that is a completed CONSORT reporting checklist (an appropriate variant of the reporting guideline is also acceptable, such as CONSORT-eHEALTH). See also: What reporting guidelines should I follow for my article?

Absence of these required materials and information, or inability to provide them upon request, may result in the manuscript being ineligible for peer review or publication.

* Some exceptions apply regarding prospective RCT registration requirements, and are listed in the Exceptions section below. 

 

Where to Include Trial Registration Information

Add registration information in the “Trial Registration" metadata field, located immediately after the abstract’s structured fields. For the correct format, see: How do I cite my trial registration? 

Mention the trial registration number and date of registration in the Methods section of the manuscript. We strongly recommend complete and transparent provision of:

  • The exact URL for the trial registration, which can be a cited URL in the text; 
  • The month, day, and year of the trial registration;
  • The month, day, and year of the first participant enrolled. Note this is distinct from the date of beginning data collection, which is always after the first participant is enrolled.

Secondary studies/analyses or substudies of a primary RCT must cite the original article that published the RCT’s primary results (if published) and state the trial registration number of the original study. This information can be included in the Methods section, not in the “Trial Registration” metadata field. See the first point in the Exceptions section.

 

Trial Registration and Ethics Approval

Trial registration is not equivalent to Ethics Approval for human subjects research (e.g., by a Research Ethics Committee or Institutional Review Board). 

For more information on Ethics Approval or Ethical Considerations, see: Institutional Research Board / Research Ethics Board and Informed Consent

Studies involving health care professionals or trainees are considered human subjects research. Both trial registration and ethics approval are required if the RCT study design, intervention, and outcomes measured meet criteria for a RCT (see RCT features listed earlier). 

 

Trial Registration and Registered Reports

Trial registration is distinct from a registered report. 

A registered report, stage 2 (RR2) is a results article that relates to a registered report, stage 1 (RR1) or protocol article. This means an original research article that reports on primary results of a RCT is considered a RR2 when a corresponding protocol (RR1) was previously published. 

If you published a related RCT protocol (RR1) as a published article, then there is a separate metadata field on the submission form to provide the IRRID of the protocol. See Submitting a results manuscript

Publishing a protocol article (RR1) does not necessarily exempt a results article (RR2) reporting primary results from a RCT from prospective registration (see the specific exception for registered reports below). 

 

Exceptions

When authors are in doubt about whether their trial qualifies for an exception to trial registration, erring on the side of caution and prospectively registering the trial is appropriate.

  • Secondary analyses or substudies of an RCT do not require a new trial registration number. However, these secondary studies are expected to: (1) include the trial registration number of the original study; (2) state in the Methods that the work relates to data collected from a RCT; and (3) cite the original article that published the RCT’s primary results (if published) and include the trial registration number from it (if registered).
  • Randomized controlled experimental studies that do not involve health, clinical, or medical interventions or outcomes on human subjects do not require trial registration. 
  • Education-related RCTs, where the study participants are health care professionals/trainees/learners, rather than patients, and the intervention or outcome measures are solely education-focused not health-related. According to the ICMJE, “If the purpose is to examine the effect only on the providers (for example, provider knowledge or attitudes), then registration is not necessary.” These studies do not require trial registration.
  • Formative/pilot/feasibility studies. Pilot RCTs involving feasibility/usability, any kind of RCTs with a small number of subjects, or RCTs exploring formative measures (either in terms of sample size or topic/approach) do not require trial registration. However, registration is strongly recommended and would strengthen the work (e.g., in JMIR Formative Research). Formative or pilot RCTs are still required to adhere to appropriate CONSORT reporting guidance. See also: What reporting guidelines should I follow for my article?
  • RCT protocol or proposals do not require trial registration upon submission or publication (e.g., in JMIR Research Protocols). However, an RCT protocol is expected to state the registration status upon submission. This informs the reader if registration is prospective.
  • The article is an RR2 for an RCT with a prospectively published protocol (before participant recruitment begins) as an RR1, including all WHO trial registration data set details. 

  • Also rare are any case-by-case exceptions. Editors only consider rare exceptions if authors provide a compelling justification for delayed or retrospective registration, and there is no evidence of biased reporting or selective outcome disclosure. In these instances, authors must explicitly state the reasons for the delay in the manuscript, and the journal will publish an Editorial Notice appended to the final manuscript explaining the rationale for the exception.

     

Editorial Notice

The editor will add an Editorial Notice if a RCT is unregistered, retrospectively registered, or only has a related protocol article without registration. This is a standard practice in accordance with the ICMJE. The ICMJE emphasizes that such exceptions should be rare.

Here is an example of an Editorial Notice that may be added to the manuscript: 

Editorial Notice: This randomized study was [only retrospectively | not] registered, explained by authors with (insert reasons here, e.g. "technical problems"). The editor granted an exception from ICMJE rules mandating prospective registration of randomized trials, because the risk of bias appears low and the study was considered formative, guiding the development of the application [or other reasons for the exception, as argued by the authors]. However, readers are advised to carefully assess the validity of any potential explicit or implicit claims related to primary outcomes or effectiveness, as retrospective registration does not prevent authors from changing their outcome measures retrospectively.

 

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