According to the Ordinance on Clinical Trials in Human Research (Verordnung über klinische Versuche in der Humanforschung, KlinV), clinical trials need to be registered in:
- a primary registry recognized by the World Health Organization (WHO) or in the registry of the U.S. National Library of Medicine
- the Swiss National Clinical Trials Portal (for clinical trials conducted in Switzerland).
Registration in the registry of the U.S. National Library of Medicine
CTU Bern administers the accounts for the University Hospital Bern (Inselspital) and the University of Bern in the registry of the U.S. National Library of Medicine, i.e. ClinicalTrials.gov.
In order to register your study on ClinicalTrials.gov, please contact email@example.com for a login (please state which organization you need the login for, the Inselspital or the University of Bern). You can then enter and update the study yourself. Please note that data must be updated regularly, i.e. at least once a year.
In case of questions or problems concerning study registration, please contact firstname.lastname@example.org.
Registration in the Swiss National Clinical Trials Portal
You can log yourself into the Swiss National Clinical Trials Portal directly on their website: www.kofam.ch
Clinical studies with positive results are more likely to be published than studies with negative or inconclusive results. The selective publication and reporting of clinical studies may be remedied by registering all clinical studies. A statement from the International Committee of Medical Journal Editors (ICMJE) published simultaneously in several major journals requires registration of clinical trials in a public database before papers are considered for publication in several of the major medical journals. Furthermore, as of 01.01.2014, registering clinical trials is a legal requirement according to the Clinical Trials Ordinance (ClinO §64).
Any research project that prospectively assigns persons to a health-related intervention in order to investigate its effects on the health, structure or function of the human body [HRA §3.l] (clinical trial) must be registered before study conduct, i.e. announcement of any study-specific information to the public or inclusion of the first patient, whichever comes first. The only exception to this are phase I clinical drug trials in adults, which must be registered no later than one year after the completion of the study.
Clinical trials may also be referred to as interventional trials. Health-related interventions include, but are not restricted to, drugs, cells and other biological products, surgical procedures, radiologic procedures, devices, behavioral treatments, process-of-care changes, preventive care, etc. This definition includes trials of diagnostic procedures, where participants are assigned to diagnostic procedures / approaches and health-related outcomes are measured. It does not include diagnostic accuracy studies (no patient-related outcomes measured but only performance measure of the procedures such as sensitivity / specificity) or observational studies (no study-related assignment of a health-related intervention).
For the Faculty of Medicine, Bern, and the Inselspital Bern, the standard registry is ClinicalTrials.gov.