Closed on Friday, 26 June 2015, 05:00pm (AEDT). Submissions are no longer being accepted.
The Australian Government is committed to improving the clinical trials environment and increasing Australia’s international competitiveness as a destination of choice for the conduct of clinical trials. In order to effect this commitment NHMRC, along with the Department of Industry and Science and the Department of Health, are undertaking a number of activities to streamline research ethics and governance approval, improve training and education of clinical trial proponents and increase recruitment into clinical trials.
One initiative being considered is the recognition of clinical trial sites, including public and private hospitals and other organisations that are ‘ready, willing and able’ to carry out high quality clinical trials in a timely, transparent and efficient manner. This proposed initiative is known as ‘Clinical Trials Ready’. NHMRC is now conducting a consultation on this initiative.
A similar initiative is already in place in the United Kingdom. The UK Clinical Research Collaboration (UKCRC) has a Registered Clinical Trial Unit (CTU) scheme that registers CTUs that meet a list of criteria. More details are available on the UKCRC Registered CTU Network website.
The main potential benefits of the Clinical Trials Ready initiative would be:
- Improved awareness, transparency and clarity,
- Less duplication of ethics and governance review processes; and
- More clinical trials would be attracted to Australia, due to faster approval processes, transparency in costs and timeframes, and the high quality of the research.
Purpose of the Consultation
The intended outcome of the consultation is an understanding of the views of stakeholders, including clinical trial sites and sponsors, on a number of fundamental aspects of the Clinical Trials Ready initiative. These aspects include:
- Whether it would add value to the existing system for conducting clinical trials in Australia;
- If such a scheme is desirable, what the characteristics that distinguish Clinical Trials Ready sites might be; and
- Views on the governance and management of the Clinical Trials Ready initiative
Terminology and definitions used in this document
Clinical Trials Ready – A proposed initiative to recognise Australian clinical trial sites that meet certain published criteria.
Site – an institution (or group of institutions) that resource, conduct and manage clinical trials that come under one final research governance authorisation sign off.
Note: closing date extended from 12 June to 26 June 2015.