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Trial Registration
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Trial Registration
 
Registering clinical trials
Many journals require clinical trials to be registered on an appropriate register, if the investigators ultimately want their results to be considered for publication. Early trial registration (before participant recruitment):
  • Allows for international appraisal of the study design and methods
  • Improves reporting and publication of all trials, regardless of the results
  • Ensures the trial is available for public scrutiny
  • Enables everyone to locate key information about the trial
  • Ensures that the many trial participants who volunteer their time will know that the information gained from their altruism is part of the public record.

There are a number of different registries. Researchers should find the registry that best suits their trial and that meets the requirements of the International Committee of Medical Journal Editors (ICMJE).

There is an agreed minimum set of data fields required for trial registries. The Australian Clinical Trials Registry will register most clinical trials. The Current Controlled Trials is an international registry providing an International Standard Randomised Controlled Trial Number (ISRCTN). The World Health Organization also maintains an International Clinical Trials Registry Platform.

Drug registration
If the clinical trial intends to use a drug intervention outside of its current approved use, investigators are required to obtain approval through the Therapeutic Goods Administration Clinical Trial Notification Scheme (TGA CTN). This is applied to interventions intending to use drugs outside of the approved route, indication, dose range, or when the drug has yet to be approved for use in the broader community. Registration does not replace the need for appropriate ethics approval, but may be requested as part of the approval process.

If a clinical trial tests an intervention using a drug or medical device where a new technology, new material or new treatment is required, and has not been adequately evaluated in clinical trials then a Clinical Trial Exemption notification is required. Researchers can locate more information about obtaining approval through this scheme from the Therapeutic Goods Administration.

 

 

This page was created on 25 March 2008 and is due for review in March 2010

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