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 Unpublished research is unethical and a waste of invested resources, scientific experience, and study participants who were exposed to potential risks.

 

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

 

Swiss Law

HRA – see in particular article

• Art. 56 Registration

ClinO – see in particular articles

• Art. 64 - 67 Registration

ClinO-MD – see in particular

Art. 41 Registration