To address the Australian Government’s commitment to improving the clinical trial environment in Australia and to built our reputation internationally as a destination for clinical trials, the Australian National Health and Medical Research Council (NHMRC) has launched an initiative considering 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.” The NHMRC is now conducting a consultation on this initiative called ‘Clinical Trials Ready’ (http://ow.ly/MvWeE).
It is great to see this initiative out there and to have the opportunity to provide input. Reading through the paper though I struggled with the overall scope and objective of the proposed initiative and I welcome other peoples’ view on it.
The paper refers to the ‘recognition of clinical sites’ and is listing general basic criteria which should apply to all investigational sites currently recruiting for studies. The ‘similar UK initiative’ quoted in the consultation paper, however, refers to registration of specialised clinical trial units with proven evidence of their ability to coordinate and lead multi-centre studies – there is an impressive list of criteria tick boxes listed on their website (http://www.ukcrc-ctu.org.uk/?page=CTURole).
The UK model also separates the rather later clinical phase clinical trial units (CTU)/investigational sites from ‘experimental medicine and early phase clinical trial’. This separation is necessary because ‘phase 1 units’ or ‘experimental medicines units’ will have different criteria to meet; especially dedicated phase 1 unit should have a more comprehensive accreditation scheme applied to.
I appreciate this new initiative kicking off, because we need more clinical trials coming our way and we need to boost clinical research activities in Australia. We should, however, take the opportunity to create a robust and selective registration scheme that covers all categories of clinical trial sites, a scheme that goes beyond ‘recognition’. We need to provide a valid register to international (and national) Sponsors where they can find top clinical trial centres that meet global standards and that deliver high quality data on time and target.