RANDOMIZED DRUG CLINICAL TRIAL STUDIES
Randomized drug clinical trial studies are biomedical or health-related interventional and/or observational research studies conducted in phases in human beings who are randomly allocated to receive or not receive a preventive, therapeutic, or diagnostic intervention that follows a pre-defined protocol. The study is intended to determine the safety and efficacy of approaches to disease prevention, diagnosis and treatment.
Authors of randomized controlled trials are encouraged to submit trial protocols along with their manuscripts. All clinical trials must be registered (before recruitment of the first participant) at an appropriate online public trial registry that must be independent of for-profit interest (e.g.,www.clinicaltrials.gov). If you wish the editor(s) to consider an unregistered trial, please explain briefly why the trial has not been registered.
- All randomized clinical trials should include a flow diagram and authors should provide a completed randomized trial checklist (see CONSORT Flow Diagram and Checklist; www.consort-statement.org) and a trial protocol.
- Studies of diagnostic accuracy must be reported according to STARD guidelines; (www.stard-statement.org)
- Observational studies (cohort, case-control, or cross-sectional designs) must be reported according to the STROBE statement, and should be submitted with their protocols; (www.strobe-statement.org).
- Genetic association studies must be reported according to STREGA guidelines; (www.equator-network.org/reporting-guidelines/strobe-strega/)
- Systematic reviews and meta-analyses must be reported according to PRISMA guidelines; (www.prisma-statement.org)
- To find the reporting guidelines see (www.equator-network.org)
Important points to remember while submitting clinical trials:
- Each manuscript should clearly state an objective or hypothesis; the design and methods (including the study setting and dates, patients or participants with inclusion and exclusion criteria, or data sources, and how these were selected for the study); the essential features of any interventions; the main outcome measures; the main results of the study; a comment section placing the results in context with the published literature and addressing study limitations; and the conclusions. Data included in research reports must be original.
- Trial registry name, registration identification number, and the URL for the registry should be included at the end of the abstract and also in the space provided on the online manuscript submission form. If your research article reports the results of a controlled health care intervention, list the trial registry, along with the unique identifying number (Please note that there should be no space between the letters and numbers of your trial registration number). Studies designed for other purposes, such as to study pharmacokinetics or major toxicity (e.g., phase 1 trials), are exempted.
- All reports of randomized trials should include a section entitled “Randomization and Masking”, within the Methods section.
- The manuscript must include a statement identifying the institutional and/or licensing committee that has approved the experiments, including any relevant details.
- The SI system of units and the recommended international non-proprietary name (rINN) for drug names must be used. Kindly ensure that the dose, route, and frequency of administration of any drug you mention are correct.
- Please ensure that the clinical trials sponsored by pharmaceutical companies follow the guidelines on good publication practice: (www.gpp-guidelines.org)
The editors reserve the right to reject manuscripts that do not comply with the above-mentioned requirements. The author will be held responsible for false statements or failure to fulfill the above-mentioned requirements.