Registration
We require all clinical trials to be registered in the public study registry before the first patient is enrolled.
To consider for publication, all authors who submitting clinical trials involving human subjects must register the trials in the public trials registry. This is in accordance with the Helsinki Declaration. We can accept only trial registration from WHO and ICMJE approved registrations, as these registers meet mandatory requirements and are considered reliable, complete, accessible, and provide adequate version control. The author must include in the manuscript the clinical trial registration number.
Red Flower Publications defines clinical trials as:
A research study whereby one or more human subjects are prospectively assigned to one or more interventions to evaluate the effects of biomedical or behavioral outcomes related to health (including placebos and control groups).
Interventions include, but are not limited to, drugs, cells, other biological products, surgical procedures, radiological procedures, devices, behavioral therapy, changes in the care process, preventive care, etc.
Health outcomes are any biomedical or health-related measure obtained by patients or participants, including pharmacokinetic measures and side effects.
Complete details of the registration of clinical trials and requirements are available on the ICJME website.
The guidelines for clinical trial registration are adapted from information provided by the International Committee of Medical Journal Editors (ICMJE) and the World Health Organization (WHO).
Data Sharing Statement
Manuscripts submitted to Red Flower Publications containing clinical trials data must contain a data sharing statement indicating:
- Whether the authors intend to share data of identified individuals
- What specific data they intend to share
- What other research-related documents will be made available
- How the data will be available
- When and how long they will be made available.
See ICMJE guidelines on data sharing and examples in the table.
Clinical trials beginning on or after January 1, 2019 must include a data sharing plan in the trial registration. All deviations from this plan must be disclosed in the declaration on data exchange when it is published.
