What is it? Why is it important?

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). By registering study results, the SP-INV fulfils regulatory, scientific, and ethical obligations (e.g. results must also be submitted to EC and Swissmedic (e.g. category B and C studies)

A study registry has many advantages:

  • It functions as a public record where basic study results are presented in a standardized format
  • It complies with required ethical obligations towards study participants
  • It ensures that research results contribute to overall medical knowledge
  • It reduced publication and outcome reporting biases
  • It facilitate systematic reviews and other research literature reviews

What do I need to do?

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

Where can I get help?

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

References

CONSORT group – see in particular

  • CONSORT 2010 Statement
  • CONSORT 25 items checklist

CIOMS guideline – see in particular

  • 24 Public accountability for health-related research

Declaration of Helsinki – see in particular principle

  • 36 Registration and Publication and Dissemination of results

International Committee of Medical Journal Editors (ICMJE) – see in particular

  • Clinical Trials recommendations

SAMS Research with human subjects – see in particular chapter

  • Chapter 11 Publication of study results

Swiss Law

FEDLEX – laws are available online under numbers

  • 810.305 ClinO
  • 810.306 ClinO-MD

ClinO – see in particular articles

  • Art. 38 Notification and reporting upon completion
  • Art. 65 Registration

ClinO-MD – see in particular articles

  • Art. 37 Final Report
  • Art. 38 Final Report Swissmedic
Abbreviations
  • ClinO – Clinical Trials Ordinance
  • ClinO-MD – Ordinance on Clinical Trials with Medical Devices
  • CONSORT – Consolidated Standards of Reporting Trials
  • CTU – Clinical Trials Unit
  • EC – Ethics Committee
  • FEDLEX- Publication Platform for Federal Law
  • ICMJE – International Committee of Medical Journal Editors
  • CTU – Clinical Trials Unit
  • SAMS – Swiss Academy of Medical Sciences
  • SP-INV – Sponsor Investigator
  • RA – Regulatory Authorities
  • WHO – World Health Organization.
Completion ↦ Ethics and Laws ↦ Publications ↦ Responsibilities
Study
Basic

Provides some background knowledge and basic definitions

Basic Protocol
Basic Statistics
Basic Monitoring
Basic Drug or Device
Basic Biobanking
Concept

Starts with a study idea

Ends after having assessed and evaluated study feasibility

Concept Protocol
Concept Statistics
Concept Drug or Device
Concept Biobanking
Development

Starts with confidence that the study is feasible

Ends after having received ethics and regulatory approval

Development Protocol
Development Statistics
Development Drug or Device
Development Biobanking
Set-Up

Starts with ethics and regulatory approval

Ends after successful study initiation

Set-Up Protocol
Set-Up Ethics and Laws
Set-Up Statistics
Set-Up Drug or Device
Set-Up Biobanking
Conduct

Starts with participant recruitment

Ends after the last participant has completed the last study visit

Conduct Protocol
Conduct Statistics
Conduct Drug or Device
Conduct Biobanking
Completion

Starts with last study visit completed

Ends after study publication and archiving

Completion Protocol
Completion Statistics
Completion Drug or Device
Completion Biobanking
Current Path (click to copy): Completion ↦ Ethics and Laws ↦ Publications ↦ Responsibilities

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