Clinical Trials Jurisdictional Working Group (CTJWG) presentation by Professor Chris Brook, Chair of CTJWG, at the Annual May Workshop on 4 May 2016.

Good morning. I’m Chris Brook and I chair the Clinical Trials Jurisdictional Working Group for the Australian Health Ministers’ Advisory Council and ultimately the COAG Health Council. I’m sorry I’m not able to be here in person today but I hope that just at this moment in real life I’m recovering from my second cataract operation. I have to say I can understand why people call East Melbourne “the Lourdes of the South” because it is quite remarkable to go, as I have done, from zero vision in one eye to complete vision in that eye, and hopefully the other one will be equally well refurbished. But enough of that.

So, my job today is to briefly discuss with you what we’ve been doing in the Clinical Trials Jurisdictional Working Group and where we might head from here. To do that I’m shortly going to put up a number of slides and I’ll talk to the slides, and then I’ll come back in with my visual at the very end to round things out. So let’s get started.

So, let’s remind ourselves where we’ve come from. In 2008, the harmonisation of medical ethics review was put forward by NHMRC and a year later the Clinical Trials Action Group began to meet jointly between health, NHMRC and industry. Those activities were designed to try and enhance Australia’s competitiveness in clinical trials (as the slide says). Ultimately, it was clear that none of those parties could, or did, have the leverage to make things change at the hospital/institutional level in relation to clinical trials. So, a different approach was really needed and that was exemplified or amplified by the subsequent review of NHMRC.

In 2013, jurisdictions worked on and implemented National Mutual Acceptance, following an earlier period of jurisdictional mutual acceptance starting in around about 2011. Following on from that, in 2014, the Clinical Trials Advisory Committee (that’s CTAC, as opposed to CTAG) was established to provide further advice to industry and health for clinical trials improvements. And CTAC continues to meet, again jointly between health, NHMRC and industry. In 2014 also, the Clinical Trials Jurisdictional Working Group was established to try and work out, through jurisdictions who after all do manage the healthcare system through public hospitals, just how we could or might find some practical opportunities to improve clinical trials. In the first instance, the work of CTJWG focussed on commercially sponsored trials because that is what our masters wanted, but that has now been extended to all clinical trials. The majority of clinical trials in Australia are actually commercially sponsored trials and this is a bit different from many other places in the world.

In implementing the work of the Clinical Trials Jurisdictional Working Group there are a number of priorities which were established after lengthy consensus discussion. The first and the most important to date has been to establish the metrics system and promote ICT interoperability, and that was led by Victoria. In fact ICT interoperability has not formed a significant part of that work because it is a tool or a bit of a given, but establishing a metrics system and making sure that we could measure it has been critically important. Let no-one think this is an easy task – getting all jurisdictions, and through them all hospitals and institutions, to have the same information collected consistently and able to be reported to a central repository has taken a great deal of time and effort and it will continue to take time and effort into the future.

The second priority was to establish national consistency for ethics and governance, and this project was led by New South Wales. That work is continuing and we should acknowledge the fine work of New South Wales, Tony Penna and James Cokayne in particular, in ploughing away at this task which I’m sure will result in fruitful material being widely available in the near future.

The third priority was improving efficiency of recruitment and accruals, again led by Victoria, although this work has been sourced to Ernst and Young in a major consultancy as auspiced by the Commonwealth.

And finally, developing a strategy for positioning Australia as a preferred location for performing clinical trials has been led by New South Wales.

In all of this, the Clinical Trials Jurisdictional Working Group has had to rely on largely voluntary effort by jurisdictions and I thank them all for their effort and help. The Commonwealth has been extremely generous and has resourced the activities that need resourcing including the major consultancy by Ernst and Young. It’s interesting to observe that as we have progressively improved performance in clinical trials, for example ethics approval, the expectations of parties have increased. So as we move towards (if you like to think of it as) getting close to fixing ethics approval, everybody now wants to focus on so-called governance and site selection. And as we approach governance and site selection, everybody wants to focus on recruitment and accrual. This is to be expected but it makes the task of this group ever more important and just that bit harder.

In relation to metrics, what we found without too much effort was that there really was a lack of reliable and consistent data; but we got to the point (we have got to the point) where all jurisdictions have agreed to the same data set, a so-called Framework for National Aggregate Statistics, and that occurred in 2015 and was endorsed by CEOs and ministers. At the same time we established draft benchmarks for the various elements of the national aggregated statistics but those benchmarks are not mandated because at the time that we were able to develop them we didn’t even have a first report. That first report has now been drafted and it represents the first consolidated picture of commercially sponsored clinical trials in Australia and, as I mentioned before, with great thanks to jurisdictions. That has been put to AHMAC but is not yet publically available as it is the first draft and needs to be very carefully considered and verified to ensure that in fact it is completely reliable. So we do intend to try and oversee the sharing of that data as the dataset does mature.

As I mentioned, a major activity has been a recruitment and accruals project led by Ernst and Young. The process of the recruitment and accruals project involves two things. First, what you might call a literature review and scan of national and international technologies and techniques which are best utilised for recruitment and accrual. The second component is a review of barriers and enablers which has involved extensive consultation through workshops in a number of jurisdictions and many other individual consultations by Ernst and Young, and we look forward to receiving that report in due course. I think that getting recruitment and accruals will in the end prove to be the most important part of the whole project.

So let’s move to the next and final slide. I’m sure you’d expect me to say that much has been achieved although it’s been a lot of hard work over a number of years, even pre-dating the CTJWG. It’s always difficult when you’re trying to do things with little resource and really a lot of voluntary effort to quickly produce apparent achievements; but I think the fact that we are able to sit today and say that we now have the first report of National Aggregate Statistics and will in due course be able to display just how we do as a nation in terms of meeting target times and, you know, expected completions will be a great advantage for the future. It goes without saying that a lot of effort is going to be required if Australia is seen as a preferred location on the basis of quality, safety, ease and effectiveness. Much is often made of the cost of conducting clinical trials and I think we have to acknowledge that the cost of conducting clinical trials in Australia is at the high end of the international experience but that is not the main barrier to international pharma or others conducting clinical trials here. The barriers are essentially effectiveness, timeliness and completion – so that is recruitment and accrual. People who are able to deliver those things will get clinical trials and will enable us to at least sustain our position in relation to international clinical trials effort. And of course without sustaining that effort it means that citizens, patients, call them what you will, will not gain early access to certain drugs and treatments that they might otherwise, and we lose the critically important sense of a research-oriented healthcare system. It also goes without saying that improvements won’t be achieved without commitment, collaboration, cooperation and ownership. And, yes, I think in the end that is going to mean determining how we best resource the activities that we conduct in clinical trials, rather than just forever assuming that they can be resourced through internal diversion of resources and/or commercial activity.

So summing up, there’s a lot contained in that short address and you are certainly welcome to have copies of these overheads after proceedings complete. For my own part, I have a vision that we need to work further on further streamlining and some rationalisation (yes, that R word) so that we end up, perhaps, in the future with clinical trials coordination nodes or centres across multiple institutions, not just one for every institution – not for the conduct of trials which will always be at the institutional level but for the coordination, approvals processes and negotiation. If, for example, we had one well-resourced clinical trials coordination centre in each of the academic health science clusters we would be in a position to have a properly resourced, high expertise, efficient group who can manage as a one-stop-shop for anybody who wishes to propose clinical trials of any sort. Now of course that’s one vision, there may be others, but it seems to me at least that we need to try and make sure that we look to the best in the world and we do what they do, and I think that’s a really good way to think of the future. Thank you for listening and I hope you have a really good day. Morning.