Dr Simon Fisher, the chief scientific officer of Novartis Australia and New Zealand, spoke with BioPharmaDispatch about how the company has evolved its approach to clinical trials and how that can be a model for achieving systemwide change.
Dr Fisher leads an organisation that managed 141 clinical trials in Australia in 2020 with an investment of around $20 million. Its trial monitoring organisation is one of the largest units of all the pharmaceutical companies in Australia with 50 people.
"We should take a step back," he told BioPharmaDispatch. "Novartis is changing. We are very much moving from a model that is about creating a medicine, getting it registered, applying to the PBAC and waiting for it to be reimbursed while the disease of patients progresses, then once you get broad access, go and push it hard to clinicians.
"We are changing because the medicines we are going to bring to market and to patients are going to change. We are going to be meeting unmet needs in diseases that have lower incidence and are seen by multiple specialties. They are more syndromal as opposed to specific diseases. So what we need to do is move from a one-on-one engagement, that we push once we get broad access, to a system-level engagement to make people aware that we need to involve the system. That means telling the system it is going to need to change so that it can embrace the medicines of the future."
He said clinical trials benefit the health system in several ways, including as a "very strong lever" to inform of the technologies and medicines coming so they can be accommodated. "They tell the system it needs to change or it is not going to be successful in embracing these medicines of the future."
"Clinical trials are critical to that but we as an industry need to consider our role at the eco-system level. How we might work closer together to inform, discuss, get feedback from, and take insights from the ecosystem, to tell them how that interplay might work and change and how we are changing attitudes.
"On clinical trials in the future, how are we going to go broader and use digital, and use technology, to make sure that patients are aware, physicians are aware, sites are aware, and both those in and outside the clinical trial are aware of the medicines that are coming in the future."
Dr Fisher said the eco-system can change when the people working within it recognise a 'shared opportunity'.
"We all see the same opportunity and that means we can 'synergise' and work towards the same endpoint...We have done a lot of work as an industry in trying to push our agenda on other organisations, or other people and institutions. It has taken a long time but I think more people now realise that just does not work.
"What we have to do is understand those individuals and organisations and their own agenda. If we share agenda items, or common problems and goals, then we can work together to actually solve them. That's our new modus operandi in the microcosm of clinical trials.
"Investigators want to do clinical trials with us for a number of reasons, one of them is because it enables them to pursue their own areas of interest. They are interested in their benchtop science and they partially fund it through their studies with us. They do that and that is fine."
Dr Fisher said the pandemic has seen Novartis and other companies accelerate the adoption of technology in clinical trials to broaden their reach and involve patient organisations.
"Technology such as remote monitoring means we can have more remote clinical trial sites. This means we do not need to fly a clinical research associate [CRA] to Dubbo. It can be a remote site. That is beautiful for Australia because it means more patients can be involved in trials. The patient organisations can play the important role of informing patients of where the trials are.
"A CRA can work from home and monitor three sites in a day. In the past, that used to take a week because they had to go to the site - fly in and fly out. Some sites are still wanting a more hands-on approach and, in that case, we are being flexible, adaptive and meeting in the middle."
He said, "At the end of the day, this helps make us and the system more adaptable to new technologies and medicines. We are not developing statins and anti-hypertensives anymore. We are developing personalised medicines that treat hundreds or just a few thousands of people, not hundreds of thousands."
On the period ahead as Australia and other countries hope to move out of the pandemic, Dr Fisher said it could be a period of consolidation given the rapid changes of the past year.
"First of all, I think we need to ensure that the model that we have created now is one that is future-proof and fit for purpose. I think that means stopping and pausing, and just checking that everything that we have done in the last year is the right thing.
"I do think you will see the pace of change slowing over the next 12 months because we have been at such a high pace, driven by the external environment, but some of that has huge potential to positively impact the eco-system.
"We have the ability today to collect, analyse and present data in real-time. We are doing it right now in the clinical trial environment. Think about the potential impact of that on the payer environment where I can tell you that if you want a clinical outcome, I can show you in real-time whether a medicine or system intervention is delivering that outcome. If that is of value to the payer, then what value is that?
"This means there is a whole new way of looking at what value medicines might bring, as opposed to the cost discussion we have been having for the last 20 years.
"In the past year, the pandemic created a burning platform for change on clinical trials because we all had to ensure they continued and patients were kept safe. Surely, we can do that across the ecosystem."
