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Hi All, thank you for this initiative.
I am interested to know what whether the panel thinks that trials in Australia will be stronger after the pandemic?
Aaron: I would hope that the pandemic has presented an opportunity for the whole Aus community to understand the role of CTs and how important they are. In addition, given the visibility of Australia conducting some of the first COVID vaccine studies i would think Aus will continue to be viewed as a destination of choice for placing CTs (from an international perspective).
We seem to have changed many aspects of clinical care during COVID. We see patients less often. We accept their own accounts of AEs. We do less tests. We take patients transport problems more seriously. Some of these changes are positive.
So what ways can CT change for the better? Do less F2F? Do more tele-trials? Do less tests?
Can we maintain quality but also reduce costs and burden of participation and conduct?
What have we learned about delivering clinical trials during this pandemic that we should take forward into our ‘new normal’?
Some learnings at CMAX include:
- That we can adapt to working from home and what we need to do so
- That we can creatively provide more broad-scope solutions to meetings with global partners, for instance at CMAX we are producing a video option to replace an in-person Site Initiation Visit
- We can provide solutions for Remote Visit Monitoring that we didn’t offer previously
- That recruitment rates improve when people who have lost their jobs see clinical trials as a way to contribute and be productive
Anita is absolutely right – everyone now is aware of the challenges of doing vaccine studies. It has become the talk of ‘virtual’ pubs – at least until real ones open! Everyone is also aware that such studies are the only way to ‘escape’ from the clutches of infectious diseases.
Of course these same insights apply across the board….so perhaps COVID can be utilised to make very clear why we need research for civil reasons and economic reasons – and not simply clinical ones? ie research determines how we live and work, our salaries and our kids education! (May have broader political education!)
In addition to my comments above, i think all of us in the sector need to continue with the collaboration we have seen over the past weeks… we have seen sites, government, industry and clinicians flex and adapt to new ways of working while remaining focused on the safety of patients and delivery of clinical trials where its been possible. imagine the leaps and bounds forward if we continue this, coupled with a mindset of ‘lets find better ways of doing this’….
Agree Carrie, the collaboration across the sector has enabled us to move forward more quickly on pinch points that have been a challenge for quite some time. From my own jurisdiction’s perspective, we have certainly tried to engage the sector earlier on some of the clinical trial initiatives that we are supporting under COVID-19 and I am sure that is the case for others as well.
Hi Anita, Can you elaborate on some of those pinch points? It would be great to hear what NSWHealth are doing differently.
Thanks Leanne, I know one of the C-19 specific issues is signatures for CTRAs. I think this is a great opportunity for the sector to work together on e-signatures for clinical trial documents. NSW LHDs use e-signatures on an institutional basis, but again, there is an opportunity now to establish a policy around e-signatures for clinical trials.
Great question about changing the discourse on clinical trials.
Perhaps changing the algorithms that make up the ’20 questions to ask your doctor’ so that it BEGINS with:
‘Is there a clinical trial relevant to my disease and my situation that we should consider?’
and
‘If not at this hospital – should I go somewhere else or can I accept it remotely?’
We have learned that we can adopt and adapt and that we can do that rapidly. That barriers we imagined as too challenging aren’t really insurmountable . Now the challenge is to maintain that momentum. To return to our state of status quo is a risk to our longer term competitiveness as we know a that all regions have also had to adopt and adapt. Our window of opportunity is now.
One of the many problems with Donald Trump announcing that he is taking ‘off-label’ hydroxychloroquine is that it is explicitly anti-clinical trials and works completely against the generation of evidence and practice improvement. No wonder the CT sector in the US responded so quickly. Just when you think………..
In answer to the question, “How can we leverage this to ensure clinicians and patients have the opportunity to consider clinical trials as part of their treatment regime for their condition?” .. Excellent question! Not sure I have the answer however, we do need to find a way to have a patient say to their doctor, “Thanks, what are my treatment options, and are there any clinical trials i can participate in?”. Its up to all of us to continue the dialogue wherever and whenever we can about why someone might want to be involved in a CT. We also need to find ways to make it easier for clinicians to be involved in studies – or by removing barriers that might prevent them from referring a pt to another clinician who is an Investigator
Agree Anita that we should take the opportunity to look at the pain points that can slow the start up of clinical trials. We need to be innovative and look as a sector in using standardised developed tools that are already available. The key to this is open dialogue and collaboration for all sectors in clincal trials (LHD’s Government, MRIs and Universities)
I think the items we need to continue to work on going forward in our new normal:
- e-signatures on documents including CTRAs
- remote access to EMR for the purpose of SDV/SDR
- reduce burden of conducting CTs by scrutinising protocols and the procedures/logistics we design for study conduct
- direct to pt drug supply
- teletrials / telemedicine
- e-consent
A lot of work to do going forward, but lets continue the collaboration… in 2 years lets look back at this time and have it be the pivot point for positive change and the point in time we took a big leap foward…
Good question Aaron, and as always, the elephant in the room. The efforts of the national joint working parties have made these issues a priority but consensus between and also within jurisdictions remains a sticking point. What we did see is HRECs within states pooling resources to respond to the pandemic to ensure rapid review processes and better allocation of resources, in ways they hadn’t done previously. Will this be the new norm moving forward? The next hurdle: how can we apply this collaborative approach to Governance review? This is a question for the CTPRG (which is no doubt already on their agenda pre Covid)….
Another area that has really opened up and then accelerated during this pandemic has been the importance of providing flexibility to patients eg telehealth, DTP and home health care by experienced research nurses. All these things have the potential to open up the available study populations to regional and remote communities across Australia, as well as making trial participation so much more practical and less burdensome for all patients and their carers, regardless of location.
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