Clinical trials

      

Registration

We require the registration of all clinical trials in a public trials registry at or before the time of first patient enrolment.

To be considered for publication, all authors submitting clinical trials involving human subjects must have registered the trial in a public trials registry. This is in accordance with the Declaration of Helsinki. Ideally, the clinical trial should be prospectively registered in an acceptable registry that is accessible to the public at no charge, open to prospective registrants, allows for the validity of the registration data to be checked and is electronically searchable. Authors must include the Clinical Trial Registration number in the manuscript.

Dove Medical Press defines a clinical trial as:
A research study in which one or more human subjects are prospectively assigned to one or more interventions (which may or may not include a placebo or control group) to evaluate the effects of those interventions on a health-related biomedical or behavioural outcome.

Interventions include but are not restricted to drugs, cells and other biological products, surgical procedures, radiological procedures, devices, behavioural treatments, process-of-care changes, preventive care, etc.

Health outcomes are any biomedical or health-related measures obtained in patients or participants, including pharmacokinetic measures and adverse events.

Full details of clinical trial registration and the necessary requirements can be found on the ICJME website.

Please note: The Clinical Trial Registration guidelines were 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 Dove Medical Press journals from July 1st, 2018, reporting on clinical trial data must contain a data sharing statement indicating:

  • Whether the authors intend to share individual deidentified participant data;
  • What specific data they intend to share;
  • What other study-related documents will be made available;
  • How the data will be accessible;
  • When and for how long they will be made available.

See the ICMJE guidelines on data sharing and example given in the Table.

Clinical trials that begin enrolling participants on or after 1 January 2019 must include a data sharing plan in the trial’s registration. Any deviations from this plan must be disclosed in the data sharing statement when published.

Updated 9 October 2019