Wearable device candidate for the
treatment of Major Depressive Disorder
From protocol design to study completion 4x faster at ⅓ of the cost
The situation
Fisher Wallace has successfully marketed and sold 100,000 units of its FDA cleared wearable indicated to treat the symptoms of depression, anxiety, and insomnia. In 2019 the FDA required premarket approval for the treatment of depressions. This meant that Fisher Wallace had a short amount of time to conduct a clinical trial and submit statistically significant efficacy data to the FDA or risk losing permission to market their product for the treatment of depression.
Before engaging Climb, Fisher Wallace partnered with a clinical trial partner who promised to meet vital timeline and budget constraints but failed to deliver. With the submission deadline fast approaching and budget running thin, real revenue was at risk with every passing day.
3 goals for the clinical trial
- execute a 255 person clinical trial on a tight timeline to support FDA approval
- maintain clear visibility into the process to maximize quality of execution and avoid repeating prior missteps
- adhere to the company’s tight budget through operational efficiency at every step of the process
UP TO 85% OF CLINICAL TRIALS FAIL WITH
MISMANAGEMENT AND COST OVERRUNS OFTEN TO BLAME
The challenge
The Fisher Wallace team knew the road to FDA approval wouldn’t be easy but the company’s future depended on completing a successful study. Proposals from Contract Research Organizations (CROs) and clinical trial sites came in at 3x their budget and were unlikely to meet target timelines. This realization left them scrambling to address three vital categories:
- Study Team: Who could execute the study protocol on time and within budget?
- Participant Recruitment: How could they engage and enroll a quality participant population?
- Retention & Adherence: What process improvements could address the study-killing 50%+ dropout rates they experienced in prior attempts?
Climb executed the trial on time and within budget, which set Fisher Wallace up to be the first ever FDA approved home-use device for the treatment of Major Depressive Disorder, ensuring the sponsor’s uninterrupted ability to distribute the investigational product
The solution
The choice to run a decentralized trial with Climb demonstrated the superior effectiveness of the Fisher Wallace device compared to oral medications and TMS and with fewer side effects than esketamine and ECT.
How Climb did it, every step of the way:
Climb and Patient Recruitment / Initial Screening:
Order of magnitude lower cost per participant with dramatically faster qualification
Prior to partnering with Climb, Fisher Wallace’s marketing cost per randomization was over $2,000. Climb fully enrolled the pivotal study at a marketing cost in the $200 range. Key factors driving success included:
- Advanced candidate targeting and engagement tracking to maximize the value of marketing dollars
- Automated qualification giving the best candidates immediate and actionable next steps
- Lightning-quick enrollment times to capitalize on the often fleeting moment of candidate intent
Climb and the Interview and Consent Process:
75% faster time to qualify and enroll participants
Prior to engaging Climb, Fisher Wallace recruited the entire study team directly. State-by-state licensing requirements meant that every participating clinician was a bottleneck. Intake interviews took weeks to schedule which resulted in many qualified applicants losing interest.
Climb was able to significantly shorten the time to Interview and more effectively enroll qualified candidates using:
- High-volume provider networks to decrease lead time from weeks to days
- Digital consent modules ensuring speed didn’t sacrifice clarity and quality at onboarding
Climb and Study Onboarding and Enrollment
40% faster onboarding
Before partnering with Climb, Fisher Wallace directly shipped all study kits to participants and then used video-based training modules to get them started. Self-pacing led to delays and confusion for many participants.
Climb’s FDA-registered 3rd party logistics partner provided a much higher quality protection of the blind while eliminating operational overhead. Live training calls with Climb coordinators drove consistency and clarity for every participant. Integrated logistics and scheduling reduced average time to randomize by 40%.
Climb and Protocol Adherence and Participant Retention
96.5% participant retention and 98% adherence
A big challenge for all clinical trials is retaining qualified participants and ensuring adherence. Climb achieved industry leading retention and adherence to the study protocol as the platform has been built for the non tech-savvy by design.
Each morning, participants spent only a few seconds recording their answers to two simple questions:
- Did you remember to use the device?
- Have you seen a change in your health?
Recording time-stamped answers directly in the app increases the quality of data compared to a daily journal which has inherent inaccuracies. Participants also received an automated text message reminding them to use the device and record their usage inside the app. Delinquent or nonadherent responses flagged to the study team for direct follow-up to maximize adherence and retention rates. Ease of use for participants and actionable alerts for study team intervention led to a 90%+ reduction in dropout rate relative to the prior attempt.
Climb and Study Operations and Visibility
24/7 operational visibility into all steps of the clinical trial
Typically many critical elements of a traditional clinical trial are managed and tracked by hand, excel spreadsheets, or other separate unconnected tools
Climb is the only turnkey platform to manage and track clinical trials end to end. Climb’s automated tracking and administration gave Fisher Wallace unprecedented visibility into every step of the process, enabling a small team to operate with confidence that the study was on track while focusing only on those participants requiring help.
The results
With Climb, Fisher Wallace was able to execute their FDA approval trial in record time and on budget despite having even tighter timelines and less money due to the initial underperforming trial attempt. This not only set the device up for a potential first-of-its-kind approval, but also ensured uninterrupted distribution of the investigational device.
“The feedback from our team, the PI, the CRO, and the participants was overwhelmingly positive. I wouldn’t want to do another trial any other way.”
Kelly Roman, CEO, Fisher Wallace
To see for yourself how the Climb platform works and learn more about our process, schedule a demo today.