Your Easy Guide to Clinical Studies

To ensure research transparency, the Swiss law (e.g. HRA) and and international ethical principles require that research results be made publicly available.

 

The statistician supports and is involved in the publication of study results. Responsibilities include to:

• Write a statistical report. The report summarizes the statistical analyses used to analyse the study data, and provides a presentation of study results (e.g. tables, graphs, pictures)
• Assist in the writing of scientific publications (e.g. poster presentations, publications in scientific journals)
• Update and present study results on recognized platforms (e.g. HumRes, ClinicalTrials.gov, WHO, EudraCT)

 

The statistician must ensure that publications are statistically sound, results are accurately interpreted, and that research findings are presented in a clear and objective manner

As a SP-INV:

• Ensure the statistician provides you with a statistical report, and that the interpretation of results are scientifically correct and presented in a clear and convincing manner
• Consult and involve a statistician when writing and reviewing your scientific publications. Prior to publication, a scientific paper is initially subjected to a peer review of experts. . Publication depends on the outcome of this review
• Ensure results are registered on study relevant registry platforms

 

Based on the requirements for research transparency, you are responsible to publish a summary of your research. Research results must be 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)
• The supplementary federal database, using a Swiss national language (HumRes)

References

ICH GCP E6 (R3) – see in particular:

• 3.17.2 Sponsor: Clinical trial/study reports
• Appendix B. The protocol – B16 Publication policy

ICH Topic E8(R1) General considerations for clinical studies - see in particular

• 6.3 Study reporting

External Links

Swissethics – see in particular

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

Declaration of Helsinki – see in particular principle

• 36 Publication of research results

SAMS Research with human subjects – see in particular chapter

• Chapter 11 Publication of study results

Swiss and international registries:

• HumRes - Human Research in Switzerland
• ClinicalTrials.gov
• WHO – ICTRP Registry Network
• EudraCT – Clinical Trials Database

 

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