What is it? Why is it important?

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 Unpublished research is unethical because study participants become exposed to potential risks as a result study participation, and it includes a waste of invested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

What do I need to do?

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

Where can I get help?

Your local CTU can support you with experienced staff regarding this topic

External Links

Swissethics – see in particular

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

Swiss and international registries:

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
Abbreviations
  • CIOMS - Council for International. Organizations of Medical Sciences
  • ClinO – Clinical Trials Ordinance
  • ClinO-MD – Ordinance on Clinical Trials with Medical Devices
  • CTU – Clinical Trials Unit
  • EudraCT – European Union Drug Regulating Authorities Clinical Trials Database
  • HRA – Human Research Act
  • KOFAM – Coordination Portal for Human Research
  • RAPS – Registry of all Projects in Switzerland
  • SAMS – Swiss Academy of Medical Sciences
  • SP-INV – Sponsor-Investigator
  • WHO – World Health Organization
Completion ↦ Management ↦ Publishing ↦ Study Registries
Study
Basic

Provides some background knowledge and basic definitions

Basic Monitoring
Basic Drug or Device
Concept

Starts with a study idea

Ends after having assessed and evaluated study feasibility

Concept Drug or Device
Development

Starts with confidence that the study is feasible

Ends after having received ethics and regulatory approval

Development Drug or Device
Set-Up

Starts with ethics and regulatory approval

Ends after successful study initiation

Set-Up Ethics and Laws
Set-Up Quality and Risk
Set-Up Drug or Device
Conduct

Starts with participant recruitment

Ends after the last participant has completed the last study visit

Conduct Drug or Device
Completion

Starts with last study visit completed

Ends after study publication and archiving

Completion Statistics
Completion Drug or Device
Current Path (click to copy): Completion ↦ Management ↦ Publishing ↦ Study Registries

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