As part of the initiative to ensure timely, transparent and efficient research governance authorisation, the Department of Health, in conjunction with NHMRC, revised the list of standard items associated with clinical trials.
This is a revision of a list and costed by the Independent Hospital Pricing Authority (IHPA) in 2013. This work, provided an opportunity to revise the activities on the list which were previously developed by NHMRC, to ensure a more comprehensive and up-to-date authorative resource for the clinical trials sector and to capture additional data on the actual costs associated with each item.
The revised list was developed and finalised with extensive stakeholder consultation, including representatives from pharma, device, and biotech companies, public and private hospitals, stand-alone Phase 1 trial facilities, contract research organisations, collaborative research groups, clinical trial networks, universities and research institutes. Health Consult conducted the consultation on behalf of NHMRC.
The costed list which has now been published on the IHPA website, reflects the national efficient price for standard items associated with conducting clinical trials in Australia. It is not intended to be binding on parties negotiating a clinical trials agreement but will improve transparency and, hopefully, timeliness of negotiations.
In June 2014 NHMRC undertook a targeted consultation to refine a list of standard items associated with clinical trials.
In September 2014 NHMRC published the outcome of the consultation and undertook an open consultation on the revised list
In December 2014 NHMRC published the outcome of the open consultation and provided the revised list to the Department of Health for costing by IHPA.
Please contact the Clinical Trials section.