Call for submissions on clinical trial cost list

Policy

The Independent Hospital Pricing Authority is seeking stakeholder input on the Development of a Table of Standard Costs for Conducting Clinical Trials in Australia public consultation paper.

The Independent Hospital Pricing Authority (IHPA) is an independent Federal Government agency established in 2011 as part of the National Health Reform Agreement negotiated by the Council of Australian Governments in August 2011.

A standardised approach to the pricing of clinical trials was a key recommendation of the Clinical Trials Action Group (CTAG), which was established in 2009 as a sub-group to the Pharmaceutical Industry Working Group and delivered its final report in March 2011.

The recently released consultation paper was developed by HealthConsult with the aim of finalising a table of standard costs for conducting Clinical Trials in Australia, as per the CTAG recommendation.

The consultation paper includes a set of proposed principles and approaches to setting the standard cost for each clinical trial activity originally identified by the National Health and Medical Research Council in 2012.

The paper asks stakeholders to respond to questions relating to the proposed principles and approaches, including their suitability and whether alternative approaches might be more appropriate.

It is considered that, once published, the principal purpose of the list and associated standard costs will be to act as a reference point for the negotiation of a trial budget between a sponsor and a health service.

While the list has been developed principally with hospitals (public or private) in mind, the consultation paper says that many of the items on the list may also be applicable to other trial settings, including community based health services and purpose-built Phase 1 Trial Centres.

Submissions are due by COB Tuesday 28 April.

All submissions will be published on the IHPA website unless respondents specifically identify any sections they believe should be kept confidential due to commercial or other reasons.

HealthConsult will also undertake a series of targeted consultations in April and May via interviews and focus groups to seek input from a range of invited stakeholders.