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), including where else the study was initially registered. By registering study results, the SP-INV fulfils scientific, ethical, and regulatory obligations (e.g. 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
• 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

• 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

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