Your Easy Guide to Clinical Studies

Study Registries are web-based platforms where detailed information on ongoing and completed studies are published.

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 Unpublished research is unethical because study participants become exposed to potential risks as a result study participation, and it includes a waste of invested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

 

As a minimum, study results should be published in a registry recognized by the World Health Organization (WHO), such as the ClinicalTrials.gov registry,

 

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 a SP-INV:

• Update all registries that were previously selected during study set-up, irrespective whether the study was completed as planned, discontinued, or interrupted
• Ensure that for all publications, measures are taken to maintain the confidentiality of study participants

 

Note

• Registries have clear requirements regarding type of information that must be published (e.g. recruited participants, study design and methods, results, the discussion and interpretation of results)
• Sharing scientific information is an important mean to further clinical research with the goal to provide improved treatment options to the general population
• Trial results should therefore be shared with the scientific community, medical professionals, and the public through conferences, presentations, press releases, or other means of dissemination

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

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