Your car, the last piece of SaaS software you used and the device you’re reading this on were all built using a gradual process of testing and iterating. It’s how humans generally build cool new stuff; coming up with a prototype, testing it with potential users, refining it in light of their feedback. But this is uniquely hard to do when the new product is a health treatment. Rightly so, potential users (ie patients) could be harmed, so regulation exists to protect patients and ensure any new treatments are safe and effective. Today, this means new health treatments must undergo clinical trials that on average take 10 years and cost >$1bn before reaching users.
Our vision at Lindus Health is that developing a new health treatment should be as easy as developing a consumer or business software product, because patients deserve better than having to wait 10 years and pay through the nose to get new treatments that work. We have just made an important incremental step in achieving this vision.
Enter pilot trials - robust clinical data without clinical trial timelines
A pilot trial uses our full Citrus platform to design, recruit and execute a trial. This provides access to robust clinical data, collected from a well designed study using validated endpoints, just as you would get with a full clinical trial. And like a full clinical trial, there is no compromise on patient safety or regulatory compliance, thanks to our Citrus platform and oversight from our clinical team. Unlike a full clinical trial, pilot trials can begin recruiting participants within a week.
What kind of products is a pilot trial for?
If the product you’re testing is already available without a prescription, or if your product’s active ingredients are themselves available in other products without a prescription, you don’t need to run a full clinical trial to provide that product to participants.
Additionally, the trial can’t affect a participant’s regular ongoing care (such as asking them to stop receiving care in order to participate, or provide a diagnosis that could affect their care).
This still means that most digital health apps, nutritional supplements, and many diagnostic devices and medicinal products are suitable for pilot trials.
It is however important that any participants provide freely given, informed consent before participating in order to conform to regulations (ICH GCP and FDA 21 CFR part 11. We’ll spare you the details, life is too short!). Our Citrus Clinical platform makes this easy, providing participants with all the information they need, and capturing their informed consent.
Differentiate your product, support marketing claims or publish your results
Data from a pilot trial can be used for many of the same use cases as a full clinical trial, including:
There are a few things you can’t use pilot trial data for, including as part of a regulatory submission for a drug or device clearance, and some payors like US insurers, DiGA or the NHS.
We think healthcare founders, like founders in other industries, should be able to test a product and collect feedback using a laptop and a credit card. Thanks to Pilot Trials with Lindus Health, it's possible to get real user feedback and build evidence for your product in weeks, not years, and it won’t break the bank either.
If you’d like to find out how a Pilot trial could deliver fast results for your product, get in touch!
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