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Step-by-step guide to setting up a clinical trial
Who to consult and what to consider when thinking about setting up a clinical trial at The Royal Children's Hospital
This site has been designed for any staff wishing to conduct a clinical trial on the RCH campus. The site provides a starting point for those wishing to explore a clinical question with a clinical trial, and contains a step-by-step guide of what to consider and who to contact at what stage for essential information. Also included are definitions, links to forms that you may need to complete, links to various internal and external support and lists of relevant courses.
The development of these pages is a joint endeavour by the following departments working together as ' The Clinical Trials Working Group' : Clinical Epidemiology and Biostatistics Unit, RCH Ethics and Research Office, MCRI Grants Office, Australian Paediatric Pharmocology Research Unit, RCH Pharmacy Department.
Even if your research question cannot be answered using a clinical trial, you may still find this site a useful resource. Much of the advice it contains is relevant to other research designs.
What is a Clinical Trial?
A well designed clinical trial provides the highest standard of evidence for assessing the impact of an intervention on a given outcome. The International Committee of Medical Journal Editors (ICMJE) defines a clinical trial as: "Any research project that prospectively assigns human subjects to intervention and comparison groups to study the cause-and-effect relationship between a medical intervention and a health outcome. This definition includes drugs, surgical procedures, devices, behavioural treatments, process-of-care changes, and the like."
http://content.nejm.org/cgi/content/full/351/12/1250