CLINICAL TRIALS

Registration of clinical trials

Registration in a public trials registry is a condition for publication of clinical trials in Ukrainian Journal of Ophthalmology in accordance with the International Committee of Medical Journal Editors recommendations. 

Ukrainian Journal of Ophthalmology requires registration of clinical trials in a public trials registry at or before the time of first patient enrollment as a condition of consideration for publication.

ICMJE uses the date trial registration materials were first submitted to a registry as the date of registration.

The ICMJE defines a clinical trial as any research project that prospectively assigns people or a group of people to an intervention, with or without concurrent comparison or control groups, to study the relationship between a health-related intervention and a health outcome.  Health-related interventions are those used to modify a biomedical or health-related outcome; examples include drugs, surgical procedures, devices, behavioral treatments, educational programs, dietary interventions, quality improvement interventions, and process-of-care changes. Health outcomes are any biomedical or health-related measures obtained in patients or participants, including pharmacokinetic measures and adverse events.

Ukrainian Journal of Ophthalmology accepts publicly accessible registration in any registry that is a primary register of the WHO International Clinical Trials Registry Platform (ICTRP) (https://www.who.int/clinical-trials-registry-platform ).

Approval to conduct a study from an independent local, regional or national review body (e.g., ethics committee, institutional review board) does not fulfil the ICMJE requirement for prospective clinical trial registration.

Authors who register their trial in non–WHO-approved registries should also register them in a WHO-approved registry.

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.

Ukrainian Journal of Ophthalmology publishes the trial registration number at the end of the abstract. 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.

See also for further guidance on registration of clinical trials:

https://www.icmje.org/recommendations/browse/publishing-and-editorial-issues/clinical-trial-registration.html  

www.icmje.org/news-and-editorials/ 

www.icmje.org/about-icmje/faqs/

Authors’ Access to Data

All authors should have the ability to review the data supporting study results. In the case of collaborations between authors from academic and nonacademic institutions, at least one author from the academic institution should have accessed the primary data and be able to participate in the analysis. With sponsored research, authors' access to the supporting data should be expressly provided for in any research agreements. Editors may ask which specific authors had access and participated in the analysis.

Data Sharing

All manuscripts submitted to Ukrainian Journal of Ophthalmology  that report the results of clinical trials must include a data sharing statement/a data sharing plan in the trial’s registration.

Research data refers to the results of observations or experimentation that validate research findings, which may also include software, code, models, algorithms, protocols, methods and other useful materials related to the paper.

Data Sharing Statement

Data sharing statements must indicate the following:

  • whether individual deidentified participant data (including data dictionaries) will be shared (“undecided” is not an acceptable answer);
  • what data in particular will be shared;
  • 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 also for further guidance on data sharing: