By Professor Steve Webb, ACTA Deputy Chair
Amongst other things, the following could describe the investigator-led clinical trials experience in Australia: “Important, valuable, rewarding, great return on investment. But often frustrating to get approval and get started; frustrating enough, on occasion, to prevent getting going in the first place.”
Such frustration, of course, isn’t by design. It is an unintended consequence of the kind of fastidious governance any reasonable person would expect to surround clinical trials. Can’t be too careful when it comes to medical studies impacting directly on patient health outcomes, can we?
Actually, we can. And we have.
Practically all stakeholders in and around the Australian clinical trials sector recognise the viscosity of health services-based clinical trials governance and believe something should be done to make it more responsive while keeping it responsible. This is much of the impetus behind a recently commenced Federal Government initiative to improve Australia’s research governance approval processes, and ACTA is very much involved.
We are working closely with the Australian Commission on Safety and Quality in Healthcare, state and federal governments, the Australian Health Ministers’ Advisory Council, NHMRC, and industry groups. If you want to know more about how this work came about, the organisations involved, and deliverables, this Clinical Trials Governance Framework
Steering Committee meeting summary provides a useful primer.
In the meantime, here’s a scenario many of us will recognise:
Before you start your clinical trial, you need approval from each research site where it will be conducted, and one of the great strengths of networked investigator-led clinical trials is your ability to recruit larger numbers of participants across many sites. The downside is that you could be seeking sign-off from commendably cautious administrators at 50 or more hospitals.
Thank goodness there is a standard legal contract between trial sponsor and each site that covers payments, responsibilities, and the like. That helps a lot, but not enough.
The approval process for each and every copy of the contract is slow and predictably pedantic, with more or less fine-tooth-comb-wielding administrators and their lawyers identifying at least as many issues as trial sites. “Who’s paying for what?” “How do individual hospital protocols and procedures map onto trial processes?” “Shouldn’t we capitalise that word on the reception poster draft?” And so on.
While doing their best, this distributed legion of administrators tasked with the minutiae of governance are often insufficiently empowered or experienced to understand the issues, and they are risk averse – just as most of us would be in their shoes.
Large, well-funded clinical trials usually generate enough momentum to overcome this systemic inertia. But for many of us – especially new researchers concentrating on day jobs – it’s expensive, tiring, soul-sapping. Small trials that may have led to huge down-the-track health benefits are too often shelved after would-be investigators decide to fight another day. We are at risk of losing a generation of researchers to governance grind.
The good news is that the Australian Health Ministers’ Advisory Council has tasked the Australian Commission on Safety and Quality to consult widely and make recommendations on streamlining clinical trials approvals through incorporating new national standard protocols into health services’ periodic accreditation reviews. ACTA is actively involved, working energetically with stakeholders across multiple forums. We are optimistic that, with careful work and consultation, the clinical trials governance balance can be shifted from burdensome to beneficial.
This initiative is certainly the best current option to improve the clinical trials governance approval process. There is a strong desire to develop something far fitter for purpose and make Australia more internationally competitive in clinical trials cost, trial start-up time, and trial participant recruitment. The initiative will include a consultation process which will be an opportunity for ACTA members to influence the outcome. We will keep you posted and ask for your input in due course.
One possible outcome is that hospitals could be required to meet a streamlined clinical trials national governance standard as an essential criterion for their overall accreditation. Then we would be moving towards a world where clinical trials were truly embedded in our health system delivering great patient and economic outcomes for Australia.