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 Unpublished research is unethical as potential future study participants may become exposed to unnecessary known risks. In addition, it is a waste of valuable resources and scientific experience.

 

Thus, based on the requirements for research transparency, researchers are responsible to publish their research results. Aa a minimum requirement, results must be made available in:

• A study relevant registry(ies), such as:
  • A primary registry recognized by the WHO (ICTRP registry network)
  • The registry of the U.S: National Library of Medicine (clinicaltrials.gov)
• A supplementary federal database (KOFAM)

As a SP-INV of a scientific publication:

• Decide authorship early on, and ensure authors have no conflict of interest
• Include experts supporting the write-up of your publication (e.g. statistician, medical reviewer)
• Favour scientific peer-reviewed journals targeting research communities of interest
• Publish in journals where research results are available online with licenses aimed at promoting reuse (e.g. no charge, less copyright restrictions)
• Adhere to defined publication agreements (e.g. inclusion of publication partner(s), authorship contribution, publication guidelines)

 

When publishing your research:

• Report a summary of your results in a clear, comprehensive, unbiased and honest manner
• Communicate valuable “lessons learned”
• Grant data access to those who may benefit from your study results (i.e. data sharing)
• As applicable, inform study participants of your study results

 

 

In order for the general public to gain access to your research results, a publication on a supplementary federal database requires that you use a (several) Swiss national language(s)

External Links

Swissethics – see in particular

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

Declaration of Helsinki – see in particular principle

• 36 Publication 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 and international registries:

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

Swiss Law

HRA - see in particular article

• Art. 56. Registration

ClinO – see in particular articles and annex

• Art. 64 Approved registers and data to be entered
• Annex 5
  • 1. Data to be entered in a register
  • 2. Data to be entered in the supplementary database
• Art. 65 Time of registration
• Art. 66 Responsibility
• Art. 67 Portal: public access to clinical trials in Switzerland

ClinO-MD – See in particular articles

• Art. 41 Registration
• Art. 42 Publication of results