International Journal of Open Access Clinical Trials(IJOACT) is an international open access, scholarly journal that publishes clinical trial reports (CTR). These reports should be prepared in accordance with the CONSORT, STROBE, PRISMA and other international guidelines (ICMJE) for reporting of clinical trial results.
The clinical trial report submitted to the journal must be prepared in agreement with the general ICH guidelines for clinical study reports (E3, E6, E8, E10 etc.). It should have a detailed protocol that has been approved by the ethics committee (IRB/IEC). Trial should be registered in a trial registry database (clinicaltrials.gov, ICTRP, EU clinical trials register etc.) before commencement of subject enrollment. The design, conduct, reporting editing and publishing of trial reports must follow international guidelines (ICMJE, CIOMS). The participant selection should be according to the eligibility criteria and all participants should have signed the 'informed consent form' voluntarily. The interests of the trial subjects should not be compromised at any point during the trial; the sponsor should conduct the trial according to the ethical principles outlined in the "Declaration of Helsinki".
WHO defines clinical trials as, "any research study that prospectively assigns human participants or groups of humans to one or more health-related interventions to evaluate the effects of health outcomes". It can be an interventional study in which the participants receive a specific intervention according to the trial protocol that has been designed by the investigators; or an observational study, where they might receive interventions, but those are not assigned by the investigators. For effective assessment of clinical endpoints the trials are designed to be controlled (concurrent standard treatment/placebo control or historical control), randomized, and blinded/masked. Randomization/Blinding is done to remove any sort of bias during statistical analysis of trial results
Prior regulatory approval based on the data submitted from the pre-clinical animal study reports is required before commencing any clinical trial. The trials are conducted in four phases- Phase I/II (exploratory safety & efficacy studies), Phase III (confirmatory safety & efficacy studies) and Phase IV (post-approval sentry studies).