ACTA has welcomed the opportunity to provide feedback to the NHMRC on the draft final report on revising the list of standard items for clinical trials for the purpose of determining national efficient prices for these items.
Here's a summary of the key comments put forward in ACTA's submission:
- ACTA notes the principal purpose of the list and associated table of standard costs “to provide an authoritative reference point for the negotiations of a trial budget…” and strongly supports the work of the NHMRC to provide leadership in developing the list as a mechanism to reduce uncertainty and variability around clinical trial costs.
- We believe the revised list and set of guiding principles outlined in the draft final report represent a much improved, streamlined version that has addressed many of the concerns raised previously.
- We believe the most significant development within the revised document is the recognition, as a guiding principle, that trial budgets should be limited to include only those services that are over and above the standard of care that would have been otherwise provided to any patient for his or her condition had they not participated in a clinical trial.
- We recognise and wish to highlight (as was noted in the report), the potential complexity of defining ‘standard of care’ within a healthcare system in which there is acknowledged variation in care. In this regard we recommend the guiding sub- principle that for the purposes of costing within a clinical trial budget, if an intervention is recognised as part of routine practice in any potential trial site in Australia, it is acceptable that it be regarded as an acceptable standard of care at all sites that are willing to participate in the trial.
- Moreover, we believe that the process of applying or ‘operationalising’ the standard of care principle will be of critical importance and that the document must provide guidance on this accordingly. The only valid and viable method is for determination of what is standard care to be made by individual hospital departments or Medicare Locals or equivalent.
- The guiding principles should recognise the enormous value of investigator-led trials to the health system. As such the costs charged to investigator-led trials, when activity exceeds standard care, should be charged at the marginal rate to the health service. In determining how much is charged, up to the full marginal cost, it is reasonable for health services to consider the potential benefit of the trial to participating patients and broader potential benefits to the institution, healthcare system and future patients.
- We strongly suggest that the document be amended to outline how sites should apply the list to ensure that the minimum threshold of critical site infrastructure for the site to be capable of conducting trials is factored within trial budgets.
Read ACTA's full submission here