Your Easy Guide to Clinical Studies

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

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

 

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 Unpublished research is unethical as potential future study participants may become exposed to unnecessary known risks.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.

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.

 

Based on the requirements for research transparency, as a minimum ensure results are 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)

 

In addition:

• Ensure that for publications, measures are taken to maintain the confidentiality of study participants
• Comply with the registry requirements regarding type of information that must be published (e.g. recruited participants, study design and methods, results, the discussion and interpretation of results)
• Ensure study results are shared with both 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

ICMJE – See in particular

• Clinical trials recommendation

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