Imagine (or maybe you are!) an early-stage digital health company. You’ve built a great product and raised some money; typically the next thing on your mind is generating clinical evidence. You need this data for multiple reasons: to support conversations with payors, get regulatory approvals, and demonstrate to investors that your product works.
And you want the data yesterday!
What options are there for generating clinical evidence?
This is an existential question for any health start-up and it can definitely feel like an overwhelming problem. Your expertise is building an amazing product, not understanding the finer points of clinical trial regulation.
We’ve spoken to a lot of companies in this position and there are typically two options being considered:
- A partnership with an academic institution or investigator
- Working with a specialist trial provider or Contract Research Organisation (i.e. with someone like Lindus Health)
There’s no such thing as a “right” strategy but there are definitely some factors to consider.
What are the pros and cons of working with an academic centre?
Academic partnerships can be excellent. Undoubtedly, having input from Key Opinion Leaders and a partnership with a high-profile institution can be game changers for an early-stage company. We do a lot of work with academic centres that deliver fast, high-quality trials.
However, these centres are not the norm and academic-led trials can face a number of challenges.
Speed: Unfortunately the pace that academic centres move at can be frustrating for fast-paced founders. It’s not uncommon to take well over 12 months from an initial conversation to actually enrolling a patient because of the bureaucracy and hoops that need to be jumped through. Once the research starts academic centres aren’t set up to recruit participants quickly, and trial recruitment periods will often be over 12 months. This delay can prove fatal to a company with a limited runway, that needs results fast.
Cost: There’s a common misconception that it’s more cost-effective to work with an academic institution than a CRO. This is rarely the case for two key reasons. Firstly academic institutions will charge overhead costs and essentially function as a private business for the purposes of research from private sponsors. Secondly, a lack of technology to streamline trial delivery means that they budget for labour costs that could be avoided by a more agile provider. Fundamentally a specialist provider will be able to be more flexible and recognise that there isn’t just one way of conducting a trial.
Patient experience: No pros and cons analysis would be complete without thinking about the impact on patients. The way traditional trials are run at academic centres (and by most CROs!) leaves a lot to be desired. Patients are often asked to come into physical centres for even the most routine data collection tasks that could happen remotely. Your product is being assessed under not-real-world conditions, and the people you’re trying to help most are being inconvenienced by a product that is supposed to do the opposite!
So what other options are there?
Given that you’re reading this on our website, you can probably guess where this is going! But seriously, we’ve designed our whole proposition to fit the needs of digital therapeutic founders like you.
Our proposition is: Fast, flexible, cost-effective, and puts the patient first. We have a hybrid approach to clinical trial delivery meaning that we can deliver trials that are fully remote all the way through to ones entirely delivered in a clinic setting - all supported by our trial delivery platform, Citrus. This means that we can design and deliver a trial uniquely suited to your product.
Don’t believe us? Get in touch and we’d love to give you a demo, or you can hear it from some of the companies we’re working with:
Ian Braithwaite, CEO of Habitual, said, “When we started looking into how we could generate clinical evidence, we were shocked at how long it would take when speaking to academic institutions. As a start-up, we need evidence on a much faster timeline.”
Caitlin Hall, Head of Clinical Research at myota, said, “Lindus Health have been very flexible during the trial design process. The speed at which we have been able to get our trial from design to submission is incredible!”
Generating clinical evidence doesn’t have to be painful.
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