Clinical Trials Ready aims to recognise clinical trial sites that are ‘ready, willing and able’ to carry out high quality clinical trials. The NHMRC is currently consulting on the Clinical Trails Ready initiative, until 5.00pm, this Friday 26 June.
The consultation focuses on both the concept of the initiative, and proposed criteria by which a clinical trials site might be recognised. A targeted consultation was previously carried out in March-April 2015.
The Australian Government is working to improve 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.
This initiative is being considered to recognise 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.
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
The consultation will be carried out via the NHMRC’s online consultations portal, located at http://consultations.nhmrc.gov.au/.