Your Easy Guide to Clinical Studies

Researchers have an ethical obligation to make their study results public, whether they are positive, negative or inconclusive.

As a minimum, study results should be published in a registry recognized by the World Health Organization (WHO) (e.g. ClinicalTrials.gov), on the federal (HumRes) website, and where else the study was initially registered.

In addition, results are submitted to the Ethics Committee (EC) and RA (e.g. Swissmedic) via a Clinical Study report, within 1 year after study completion.

 

A study registry has many advantages as it:

• Functions as a public record where study results are presented in a standardized format
• Complies with required ethical obligations towards study participants
• Ensures that research results contribute to overall medical knowledge
• Reduced publication and outcome reporting biases
• Facilitates systematic reviews and other research literature reviews

As SP-INV:

• Update any selected internationally recognised public registries
• Update the HumRes federal registry (i.e. the registry becomes automatically updated though information entered in BASEC)
• Make an attempt to publish your research results in a scientific peer-reviewed journal, making findings more easily available to the scientific community
• Include experts able to support you with the write-up of a scientific publication (e.g. statistician, medical reviewer)
• With the aim to further medical research, grant data access to all those who may benefit from your study results, (e.g. with or without proven benefit)
• 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 the prospect of informing study participants and/or their community about your study results
• Ensure that for all publications, measures are taken to maintain the confidentiality of study participants

External Links

Swissethics – see in particular

• BASEC The Business Administration System for the Ethics Committee
• RAPS Registry, a database of all projects approved by the ethics committees in Switzerland

Swiss and international registries:

• HumRes - Coordination portal for Human Research in Switzerland
• 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

CIOMS guideline – see in particular

• 24 Public accountability for health-related research

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 articles

• Art. 41 Registration