Clinical Trial Registration
Health and medical research, which evaluates the effect of an intervention on biomedical and human health-related outcomes, requires clinical interventional trial registration.
According to the World Health Organization, ‘the registration of all [clinical] interventional trials is a scientific, ethical and moral responsibility.’ Clinical interventional trial registration benefits researchers, trial participants and clinical practitioners. Transparency in past and present clinically relevant research warrants the availability of as much evidence as possible for informed decision making.
Australia supports this view as outlined in the NHMRC Funding Rules, and trial registration in the Australian New Zealand Clinical Trial Registry (ANZCTR) before the start of participant recruitment is recommended.
To date, the definition of a clinical interventional trial is broader than the clinical trial of new therapeutic drugs or tools tested for effectiveness and applicability in Phase I to IV. Nowadays, clinical interventional trials include all research that prospectively recruits human participants to undergo a health-related intervention so that the effects on health outcomes can be evaluated. A randomised approach to prevent bias is not required for registration.
The current definition of a clinical trial has also been adopted by the International Committee of Medical Journal Editors (ICMJE), and their globally supported recommendations on research integrity and publication ethics includes clinical trial registration as a requirement for publication of the trial outcomes in the international peer-reviewed literature.
The latest recommendation by ICMJE is the ethical obligation for responsible data sharing of research information collected in clinical interventional trials. This can be achieved with de-identified data and considerations can be made for sensitive medical and health data. Since 1 January 2019 most international peer reviewed journals of standard require that a data sharing statement is included in publications of registered clinical trials. Notre Dame’s Research Data Management policy and procedure allow for compliance with this aspect of responsible clinical research conduct.
A clinical Interventional Trial Checklist is available to provide insight into the timeline and order of events involved in research projects, which require trial registration.