Your Easy Guide to Clinical Studies

The aim of a Scientific Publication (SP) is to:

• Make scientific discoveries and progress available to the research community
• Make study results available to the general public
• Provide data for further research

 

Researchers have an ethical obligation to make their study results public, whether they are positive, negative or inconclusive. Unpublished research is unethical because study participants become exposed to potential risks as a result of study participation, and it includes a waste of resources and scientific experience.

Study results should therefore be shared with the scientific community, medical professionals, and the public through conferences, presentations, press releases, or other means of dissemination.

 

Study outcome should be:

• Published in a national- or international study registry (as a minimum in a registry recognized by the World Health Organization (WHO), such as the ClinicalTrials.gov). Valuable “lessons learned” should also be communicated
• Reported in a clear, comprehensive, unbiased and honest manner

As a SP-INV:

• Update the study on any selected internationally recognised public registries

 

For a scientific publication:

• Decide authorship and author positions early on. Ensure authors have no potential conflict of interest
• Try to publish your research results in a scientific peer-reviewed journal that targets applicable research communities. Grant data access to all those who may benefit from your study results
• Include experts able to support you with the publication write-up (e.g. statistician, medical reviewer)
• Adhere to publication agreements defined at study start (e.g. selection of publication partner(s), contribution and authorship, adherence to publication guidelines such as the ICMJE)
• Consider informing study participants and/or their communities about your study results

 

Preferably publish in journals where research results are:

• Available online providing open access licenses aimed at promoting reuse
• Free of cost with less copyright restrictions

Avoid “predator”-journals – which are of poor quality

External Links

Swissethics – see in particular

• RAPS Registry, a database of all projects approved by the ethics committees in Switzerland

 

Swiss and international registries:

• KOFAM (SNCTP) - Swiss National Clinical Trials Portal
• ClinicalTrials.gov
• WHO – ICTRP Registry Network
• EudraCT – Clinical Trials Database

 

References

Declaration of Helsinki – see in particular principle

• 36 Registration and Publication and Dissemination of results

SAMS Research with human subjects – see in particular chapter

• Chapter 11 Publication of study results

ICMJE – See in particular

• Clinical trials recommendation