Real world clinical trials.
Clinical trial software for hard reality
When the FDA and NIH shifted everyone’s focus to “real-world” data and outcomes they didn’t write their guides and policies with Storyline in mind, but they might as well have. Because dealing with the harsh realities of the real world is where we started - it’s what we’ve been doing from the beginning. We didn’t have to move an inch.
So, as you begin your own shift to “real-world” clinical trials, you’ll find that we’ve been here all along, and happy to share what we’ve learned.
Researchers and physician scientists turn to Storyline for clinical trials that capture real world data, from real world patients, in the real world.
Clinical trial software for the real world.
When designing your next clinical trial, keep a few ugly realities in mind.
Real world clinical trials are no place for sissies.
As a small pharma or biotech startup, the odds your facing as you design your clinic trial are brutal.
According to Nature, the average real world failure rate for drugs entering clinical trials is 90.4%. For some, like oncology drugs, it’s even worse (95% fail).
The cost’s are ugly, too. A Tufts study found that once you incorporate factors like opportunity cost, time lost, and risk, it takes $2.7 billion to bring a new drug to market. (Of course those are the big boys. If you’re a tiny pharma startup on a shoe-string budget you may only spend a few hundred million.)
And it’s painfully slow - 7 years to go from first clinical trial to clinical use, which is just about the time it takes to make your new discovery obsolete.
Pile on the new requirements to now incorporate real world data and outcomes and It doesn’t make a very pretty picture.
With Storyline, you may find that a lot of things you’re used to being ugly, won’t be ugly anymore.
For instance, it’s pretty fast. Our last clinical trial of 480 patients took us a couple of hours over the weekend, and it bumps your teams productivity by 4x or more, which is a pretty big bump.
It works with everyone - in the toughest populations. Storyline’s used to predict suicidality and violence in jails and prisons, identifying homeless people who can be helped, and predicting treatment responses, safety, and outcomes in cancer, psychiatric, and Alzheimer’s patients.
It’s also a bit cheaper. You can test the platform and begin collecting data for free, and if you upgrade to a full-featured kitchen-sink Team account it will set you back a mere $239 a month – $2,870 a year. (That’s around $33,630 less than most clinical trials pay for just one patient - $36,500 on average. )
And a lot smarter. (Read more about our behavioral data and science.)
But the nice thing is, when you get your first glimpse of a clinical trial done with Storyline, you’ll get a new perspective on your future.
It may end up making the ugly reality almost beautiful.
Real world people.
We already interact and work with people in the most challenging real-world environments, from Alzheimer’s patients to inmates in jails to homeless people on the street.
We’re built for real people. We understand that every interaction is a life that deserves to be treated with dignity and respect.
More about programs >
Real world data.
Storyline is designed to collect real-world behavioral data that can be used on its own, or added to any existing study to provide entirely novel approaches and discoveries.
Our StoryARC, StoryTIME, ScreenPLAY, and POEM files make it easy to use your familiar tools to work with and use behavioral data immediately.
More about our data >
Real world science.
Storyline is built to collect and use data from millions of people, solving many of the fundamental issues with old clinical trial design.
We’re focused on real-world science to open up entirely new areas for scientific discovery and charting the path to low-cost, precision care for everyone.
More about our science >
See clearer with 1 million times the data.
Storyline captures 1 million times the data that’s in a typical medical record, and can easily integrate with other datasets like blood tests, genome, and imaging. Our data gives you the resolution you need to find and identify entirely new patient sub-types, phenotypes, and biomarkers for treatment response, safety, and patient outcomes.
An endless blue ocean of opportunity.
Current clinical trial designs are high risk. Either you succeed or you lose everything.
Storyline changes that equation for you in a number of ways. First, you can collect data on-demand, allowing you to implement Bayesian trial designs that quickly winnow the winners and losers. Second, the behavioral data we collect is the richest, most predictive data of real world efficacy, safety, and outcomes. Third, it’s easy to implement alongside any other data you’re collecting.
The result is that we can link our data to the underlying biology to find new behavioral biomarkers for treatment response, dosage, efficacy and outcomes, giving you the ability to identify novel patient subtypes that dramatically increase your odds of success.
Bayesian trial design
Adaptive clinical trials using Bayesian methods are challenging to design and implement with current tools that are infrequent, expensive, and often sparse.
As an A.I. data platform, Storyline’s ability to capture, accumulate, and use high-quality behavioral data is perfectly suited for Bayesian trial methods, reducing risk and providing potential alternative paths to success.
Scalable behavioral biomarkers
Wet lab, genomics, and imaging biomarkers adds significant cost, time, and access hurdles for anyone who can benefit from your future treatment or drug.
By linking behavior to the underlying biology it’s now possible to identify behavioral biomarkers that are low cost, scalable, and can be incorporated into precision care pathways. By finding these biomarkers of patient response and efficacy in your clinical trial, you’re also building the screening and assessment tools necessary to remove current hurdles and make the largest impact possible with your new intervention, drug, or care pathway.
What you’re really buying is a bigger opportunity funnel.
Real-World Clinical Trials
Think building your company is hard? Try closing it down.
To succeed in todays market, small pharm and biotech companies have to thread the needle - managing to perfectly time and execute successful clinical trials in an ecosystem with a less than 10% chance of success.
For many young companies, a single clinical trial can mean life or death.
Storyline can improve the odds in your favor:
Capture real-world data on-demand about treatment efficacy, safety, co-morbidities, reactions, and outcomes - giving you new opportunities to identify sub-populations, responsive groups, and target screening for new opportunities for your intervention.
Uncover previously unrecognized end points and characterize heterogeneous rates of disease progression. You’re building valuable data sets and understanding that no one else has about the conditions you’re targeting.
Discover novel behavioral biomarkers for treatment response that become preliminary screening tools. Now, as you move through trial stages you’re building the response predictions that give you the tools you need to identify responsive patients of every stage of your trial, and that become the screening tools in the real world.
So before you roll the dice and take your chances, may we suggest that you see how we can improve your odds?
For many biotech and pharmaceutical companies, the penalty for choosing the wrong clinical trial software is death.
How can we utilize a control group when using a placebo is problematic - psychedelics for example?
For many hard-to-resolve clinical trials, the answer is often the data type you’re using. Storyline’s behavioral data provides the resolution to reveal subtle but highly sensitive measurements that open hard to access areas of research.
I’m interested. How do I get started?
Our trial is already designed or running. Can storyline work with our existing process?
Absolutely, yes - if you can amend your IRB.
Storyline can be added to any existing clinical trial or human research, even after you’ve launched.
Real world clinical trial?
Can I get a demo account?
Yes. Just sign up for an account here. You’ll be able to use Storyline and see how easy it is design real world clinical trials, but you won’t able to extract behavioral data or generate files without a research account. For that, just contact us >
Of all the paths your clinical trial can take, make sure a few of them are dirt..?
Make sure you have all of the data you need, on and off the beaten path.
The cost of just one patient in a clinical drug trial.
Average failure rate for new drugs entering clinical trials to make it to market.
Average time to go from first clinical trial to market.
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