Clinical Trial Registration
The publication of results of all randomized control trials will only be considered if the ICMJE recommendations are followed. A trial registration number will have to be provided with the manuscript and should be mentioned after the end of the abstract. The trial should have been registered prospectively. Retrospective registration will not be considered. If the Trial was conducted without registration, the article will not be accepted for processing. Pilot studies of clinical trials will not be considered in the category of RCT or an original article.
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 cause-and-effect 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, behavioural treatments, educational programmes, 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.”
The ICMJE endorses the following:
i. Any registry that is a primary register of the WHO International Clinical Trials Registry Platform (ICTRP)
iii. The Drug Regulatory Authority of Pakistan (DRAP) also provides approval and trial numbers for clinical trials involving drugs or appliances (http://www.dra.gov.pk/)
iv. A number of other clinical trial registries and their details can be found on the internet.