Definition
AfAc Publisher follows the International Committee of Medical Journal Editors' (ICMJE) definition of a clinical trial. This definition states that a clinical trial is any research study that:
- Prospectively assigns participants: Participants are enrolled in the study based on a pre-determined plan, not chosen retrospectively.
- Involves interventions: The study evaluates the effect of a health-related intervention, such as drugs, surgeries, devices, or behavioral changes.
- Studies health outcomes: The research focuses on measuring the impact of the intervention on a participant's health, including both positive and negative effects.
- May or may not involve comparison groups: The study may compare the intervention to a control group receiving a different treatment or no treatment at all, or it may be a single-arm study.
Additionally, AfAc Publisher encourages the registration of all clinical trials. Registration provides transparency and allows for better tracking and evaluation of research.
Registration Requirements
AfAc Publisher mandates the registration of all clinical trials in a public registry before enrolling the first participant. Acceptable registries include any primary register of the World Health Organization's International Clinical Trials Registry Platform (ICTRP) or ClinicalTrials.
Registration Details:
- The trial registration number must be clearly displayed at the end of the manuscript's abstract.
- Secondary analyses of existing clinical trials (primary or parent trials) do not require separate registration, but should reference the original trial's registration number.
- The researchers followed the approved research protocol and maintained acceptable research standards throughout the study.
Unsure about Registration?
Authors unsure of registration requirements can refer to the ICMJE FAQs for further guidance.
