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). 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

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

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