As part of PCT TV at Partnerships in Clinical Trials Europe, we spoke to Willie Muehlhausen, Head of Innovation at CRO ICON, about what he sees as the biggest challenge facing clinical trials today - patient recruitment, and what changes the industry can make to tackle it.
Watch the full interview or read the key takeaways below.
What is the biggest challenge facing trials today?
'The number one challenge to everyone in the industry is patient recruitment...as we all know, we don't have enough patients. Sites quite often don't recruit enough patients - 11% of sites don't recruit a single patient into a trial. At the same time we spend billions of dollars on patient recruitment initiatives within the industry. So if we can tackle that and make it easier for patients to be on clinical trials, that would be a key improvement.
I also think that sites need more support, and we need to find out how to support them. We all talk about 'burden' on a regular basis - site burden, patient burden - and we at ICON have started a research program to find out what that really means. What constitutes burden for patients or for sites? And what can we do to either mitigate that or, the better option, remove it? I think it's important that we fix that.'
What are the biggest barriers to patient recruitment?
'One is awareness; only 1% or 2%, depending on whether you're in Europe or the US, of patients know about trials, that participating in clinical trials in an option.
The other thing we want to do is make it easier for patients to join a clinical trial. Technology can help with that - eConsent is one example where we can tell patients in a more comprehensive way, but also in an easier way to comprehend what it is that they're signing up for.
We can also help sites to find the right patients. We would for example do pre-screening based on the patient records that they have to help them to find the right patients. On that same topic, protocols are getting more and more complex - in the last 10 years they've gone from 110 procedures per protocol to like 160 or 170 procedures.
The complexity has gone up, so it is more difficult for the sites to be compliant with the protocol, and more difficult with the inclusion and exclusion criteria to find the right patients.We have solutions and we think we need to develop solutions to make that easier for sites to enroll the right patients at the right time for the right study.
The other challenge that we see is that patients quite often drop out of a study - around 30% on average don't finish a clinical trial...so patients need to be replaced. We need to do more to find out what it is that makes drop out.'
What can Sponsors be doing to improve patient recruitment?
'I think there are a couple of things. One of the key things is what I mentioned before around awareness - they need to make more noise around trials and what the benefits are for a patient. And we need to find out what it is that makes patients drop out...Once we have more knowledge around that then we can changes the processes.
Again, it's about sites as well. I mentioned eConsent before, but I think we should make it easier for them to manage clinical trials. That could be done in a host of different ways - for example we should take the administrative burden away, payments should be made on time.'
Patient recruitment and engagement will be one of the key topics discussed at T3: Trials, Tech and Transformation in Raleigh, North Carolina on May 30-31, 2018. Explore the agenda or book a pass from as low as $399.