The clinical trial landscape is ever-changing with technological advancements, changing attitudes to partnerships and new types of drug impacting the industry. But where is it moving and what will be the biggest changes in the coming years? We asked four clinical experts - representing CROs, sites and patient networks - to look into their crystal balls and predict how trials are going to change in the next five years.
Dr. Raphaela Schnurbus - Clinical Solutions Director at CRO OPIS
‘The biggest change for sure is linked to the management of big data, and the data processing that needs to be guided and protected as it is moved from one source to another, from one stakeholder to another, not only at a local level, but at international level. Still each geographic area has its own guidelines and rules. So I think data processing, data protection, data privacy is a big question not only for lawyers, but for all the stakeholders, the authorities, for pharma/biotech companies and for service providers. All are involved and touched by this.
In our company there are some very challenging situations where we need to protect data from European companies and non-European companies. There's the globalization of trials and as the trials get more and more global, they get more and more complex and that means that costs are rising... To be more aligned and streamline all the processes means there will also be more efficiency which will save money.’
Dr. Julie Vallortigara - Research Officer at Ataxia UK
‘I think in the next four or five years, I can see the landscape of orphan drugs being expanded, with more new drugs being developed and tested, as well as more drugs being repurposed. Drugs that already exist on the market licensed and approved for a particular condition, being repurposed for a rare disease from my point of view is one of the best avenues to explore to find effective treatments in a reasonable time frame for people living with a rare condition.
I think what we'll also see in the next few years is more partnerships because the interest from pharma companies is increasing in rare diseases so there are more connections being made with patients and patient organisations. We need to work together more in order to design and run more successful trials and engage with more patients. It's a hope and expectation that more partnerships will happen in the next few years.'
Vivienne van de Walle - Director and Research Physician at the independent research site PT&R
'We see that a lot of pharma companies now outsource their clinical operations business. We're not dealing directly so much with the Sponsor anymore, but more with CROs, or CRAs that are being hired by the Sponsor and they're acting as a CRA Sponsor but are actually from a CRO. So, there's this new structure.
I think it was actually last year (2016) that for the first time we broke the margin of over 50% was no longer working directly for the pharma company, but actually through CROs. It's a big shift.'
Matt Cooper - Business Development and Marketing Director at NIHR Clinical Research Network
'The digital agenda is going to be really big, as well as the personalisation, but for us the other piece is about the real world data. As data and healthcare records get more linked together, the ability to do really good randomised real world evidence trials will be key. Countries like the UK are really well placed to take on board those sorts of studies.
The Salford Lung study has been a really good example that's been globally recognised as a unique and innovative way to do these real world evidence trials. I think we'll see more of a shift in that direction to look at getting not only efficacy data, but effectiveness data. The trials will be answering the questions that the payers are going to want to know, so it's not just 'does the drug work and is it safe?', but is it going to work in a wider population?'
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