Innovating Patient-Centric Trials:
How Sponsors are Using Tasso to Drive Compliance for Acute Onset Dosing PK
Patient adherence is key to a successful clinical trial. Collecting PK samples to facilitate exposure-response analyses for unpredictable, acute onset conditions can present unique adherence challenges. “Sponsor N” worked with Tasso to operationalize a remote, patient-centric PK sampling solution that overcomes long-standing collection and compliance barriers in clinical research.
Despite industry advances, non-adherence to study protocols remains a major threat to clinical trial data quality and study success. Poor compliance necessitates larger sample sizes to maintain statistical power, which in turn increases operational costs and delays timelines.
For spontaneous conditions, where dosing is tied to acute and unpredictable symptom onset, the challenge intensifies. Traditional clinic-based pharmacokinetic (PK) sampling is not typically feasible for these studies, yet remote solutions must rely on a patient experiencing pain to collect their own sample. “Sponsor N”, a clinical-stage pharmaceutical company, was seeking better solutions to facilitate at-home, time-sensitive PK sample collection.
Solution Design
The sponsor was seeking an easy and subject-acceptable means to allow an adjunct PK exploration to be included in their Phase 2 study when onsite sample collections would not be feasible. Legacy remote sampling methods have been used by sponsors in other clinical trials, but had not achieved optimal compliance. Tasso, a leader in patient-centric decentralized blood collection, was a natural partner for the project. Sponsor N and Tasso teamed up to design a tailored collection strategy and training system that would facilitate seamless operational implementation.
Trial participants would receive all PK sampling materials at their initial enrollment appointment, minimizing the number of clinic visits. The materials included a custom Tasso sampling kit for each timepoint, as well as clear instructions and study information. Once a participant met the pain requirements, they would dose themselves and then collect 2-, 8-, and 24-hour post-dose samples, which would be returned at the next clinic visit.
Would patients suffering from a painful condition be willing and able to collect their own blood samples? It was time to find out.
Compliance Achieved
The tailored, patient-centric solution paid off. Adherence results for the PK sample collection far exceeded typical rates for traditional clinic-based studies, especially for trials involving acute, unpredictable conditions. 99.8% of patients attempted to collect their 2-hour PK sample and compliance was above 98% at all three timepoints.
Sponsor N’s custom Tasso program had several key features which led to success. Unlike legacy remote sampling methods used by other sponsors in the past, Tasso’s sample collection device is easy to use and virtually painless, a must for patients. The dried blood spot (DBS) samples collected simplified logistics, since no cold chain or immediate shipping was required. Customized kits reduced the potential for participant error and bespoke training from Tasso empowered sites to confidently educate.
Looking Ahead
The success of Sponsor N’s Tasso sampling protocol demonstrates how innovative, patient-centric clinical trial solutions can drive adherence for spontaneous condition exposure-response analyses. Future optimizations could include automated sample barcoding, providing additional collection materials, or broader digital integration. Sponsors and CROs should continue to explore and develop best practices for these powerful new technologies.
This collaboration between Sponsor N and Tasso showcases how decentralized blood collection can transform clinical trial design. Patient-centric tools, coupled with strong site support and customization, enable high compliance and robust data collection without reliance on clinic visits. As the clinical research ecosystem continues to shift toward remote and hybrid models, tailored solutions like this will become essential to modern drug development.