For that reason, the ICMJE encourages registration of research with non-trial designs, but because the exposure or intervention in non-trial research is not dictated by the researchers, the ICMJE does not require it. Secondary data analyses of primary parent clinical trials should not be registered as separate clinical trials, but instead should reference the trial registration number of the primary trial. The ICMJE expects authors to ensure that they have met the requirements of their funding and regulatory agencies regarding aggregate clinical trial results reporting in clinical trial registries.
The ICMJE will not consider as prior publication the posting of trial results in any registry that meets the above criteria if results are limited to a brief word structured abstract or tables to include trial participants enrolled, baseline characteristics, primary and secondary outcomes, and adverse events. The ICMJE also recommends that, whenever a registration number is available, authors list this number the first time they use a trial acronym to refer either to the trial they are reporting or to other trials that they mention in the manuscript.
Editors may consider whether the circumstances involved in a failure to appropriately register a clinical trial were likely to have been intended to or resulted in biased reporting. Because of the importance of prospective trial registration, if an exception to this policy is made, trials must be registered and the authors should indicate in the publication when registration was completed and why it was delayed.
Editors should publish a statement indicating why an exception was allowed. The ICMJE emphasizes that such exceptions should be rare, and that authors failing to prospectively register a trial risk its inadmissibility to our journals.
Illustrative examples of data sharing statements that would meet these requirements are provided in the Table. Authors of secondary analyses using shared data must attest that their use was in accordance with the terms if any agreed to upon their receipt. They must also reference the source of the data using its unique, persistent identifier to provide appropriate credit to those who generated it and allow searching for the studies it has supported.
Authors of secondary analyses must explain completely how theirs differ from previous analyses. In addition, those who generate and then share clinical trial data sets deserve substantial credit for their efforts.
Those using data collected by others should seek collaboration with those who collected the data. As collaboration will not always be possible, practical, or desired, the efforts of those who generated the data must be recognized. If the purpose is to examine the effect only on the providers for example, provider knowledge or attitudes , then registration is not necessary.
The ICMJE considers trials that began enrollment before July 1, to be "ongoing" if the investigators were still collecting, cleaning, or analyzing data as of July 1, Ongoing trials require registration before submission to a journal. Do trials that began before July 1, need to be enrolled before September 13, in order to be eligible for consideration at an ICMJE journal? Investigators should register trials that began enrolling patients any time before July 1, as soon as possible if they wish to submit them to a journal that follows the ICMJE policy.
While the ICMJE hoped that all such trials would be registered by September 13, , the committee understands that the policy statement was not entirely clear. However, beginning on September 13, , ICMJE journals will consider such trials only if they were adequately registered before journal submission.
The ICMJE journals will accept "retrospective registration" of trials that began before July 1, retrospective meaning registration occurs after patient enrollment begins.
ICMJE journals will consider trials beginning on or after July 1, only if registration occurred before the first patient was enrolled "prospective registration". It is important to note that the ICMJE clinical trial registration policy requires prospective registration of all interventional clinical studies, but does not require results reporting for registered trials. However, editors of journals that follow the ICMJE recommendations may consider posting of more detailed descriptions of trial results beyond those included in ClinicalTrials.
The ICMJE anticipates that the climate for reporting results for registered trials will change dramatically over coming years and the ICMJE may need to amend these recommendations as additional agencies institute other mandates related to results reporting.
What if my device trial is covered by the delayed posting "lock box" provision of Food and Drug Administration Amendments Act of FDAAA or 42 CFR Part 11, meaning that the registered information is not publicly accessible immediately following registration? The ICMJE does require public, prospective registration of clinical trials of all interventions, including devices. When providing registration information to ClinicalTrials.
FDA Approval or Clearance" data element. Doing so authorizes NIH to post publicly registration information for the device clinical trial and will ensure that your registration is compliant with the ICMJE policy.
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