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Step-by-step guide to setting up a clinical trial

The guide

If you are developing your own project for the first time, you may be surprised at how much work is involved in designing a clinical study, and you may need help from a broad range of experts. You will be seeking to publish the findings of your research and this implies that it needs to be designed, conducted, analysed and presented to a high standard. Taking the following steps should ensure that the success of both your research application and its results is maximised. Please note that developing a research idea is an iterative process and will involve movement back and forth between these recommended steps.

Definitions of terms used can be found in the Glossary by clicking on the highlighted term.  Please see Further Considerations for other issues that you may need to consider.

1. Talk to your line manager, supervisors and senior researchers about your idea.
    
2. Adopt the PICOT approach to refine your research question and help with performing a literature search around the area.
    
3. Find relevant collaborators who will improve the quality of your research. This may include making contact with a relevant Theme director within Murdoch Children's Research Institute  (MCRI).
    
4. Arrange to meet someone in the Clinical Epidemiology and Biostatistics Unit (CEBU), involving your collaborators, to help you focus your idea and discuss further input in relation to study design, randomisation, data management, analysis plans, sample size requirements, and potential ongoing support and/or collaboration.
    
5. Start focussing your ideas and begin writing a study protocol.
    
6. If you are carrying out a drug trial, or for further help regarding methods of recruitment, trial conduct, study protocol development etc., contact the Australian Paediatric Pharmacology Research Unit (APPRU).
    
7. Contact the MCRI Grants Office to discuss how to write a grant proposal, possible funding sources and methods of application.
    
8. Speak to the RCH Pharmacy - Clinical Trials department if the study involves the use of medication.
    
9. Contact the RCH Ethics and Research Office for advice on completing ethics forms, writing Information Statements and Consent Forms, obtaining ethical approval and for assistance with legal and regulatory requirements.
    
10. Set up regular project planning meetings with your collaborators, including a statistician and other relevant experts. Once funding has been received, this group may expand to include any of a trial co-ordinator, data manager, administrator, trial statistician, research nurse(s) etc.