Blood collection stands at the heart of medical research and clinical trials, serving as a cornerstone for diagnostics, drug development, and understanding human health. As the landscape of healthcare innovation evolves, a significant shift from traditional site-based blood collection to patient-centric and remote sampling has emerged. This transformation brings a paradigmatic change, particularly in decentralized clinical trials, promising increased accessibility, efficiency, and data richness.
In this article, we explore insights gained from conversations with Dr. Erwin Berthier, the co-founder and CTO of Tasso — a company at the forefront of revolutionizing blood collection methods. Recognizing the challenges of traditional blood collection methods, particularly in recruiting patients and coordinating resources, Berthier and Tasso’s co-founder birthed the idea to create a solution that not only addressed logistical challenges, but also empowered various research endeavors, from investigator-led studies to decentralized clinical trials. Through his expertise, we aim to provide a comprehensive overview of the transition from conventional approaches to patient-centric sampling.
Blood tests have traditionally required patients to visit centralized locations for sample collection. However, the advent of decentralized clinical trials has prompted a re-evaluation of this approach.
Decentralized clinical trials leverage remote blood collection to transcend the limitations posed by traditional, site-centric models. Berthier notes that this shift addresses a longstanding compromise within clinical trials — balancing the scientific objectives of researchers with the operational challenges of patient participation. By removing barriers associated with frequent patient visits, particularly in geographically dispersed trials, patient-centric sampling opens new windows into understanding disease physiology and human health. This newfound flexibility not only aids in trial retention but also facilitates the acquisition of critical data at unpredictable moments, such as post-epilepsy events or other health incidents.
The transition to remote blood collection brings forth a great deal of benefits that ripple across medical research, pharmaceutical development, and patient inclusivity. Berthier sheds light on the advantages for researchers and pharmaceutical companies, emphasizing the acquisition of more data and the ability to gather information at previously challenging time points. Notably, Tasso's involvement in a clinical trial where patients were required to provide a blood sample after a sudden onset health event, exemplifies the profound impact of patient-centric sampling in scenarios where immediate sample collection is crucial.
Beyond the scientific world, there exists a compelling diversity and access argument from the patient's perspective. Berthier underscores the significance of making trials and healthcare more inclusive by overcoming geographical barriers. In collaboration with the University of Washington, Tasso demonstrated the feasibility of recruiting participants from locations as diverse as rural Montana, Alaska, and Hawaii. This inclusivity extends beyond scientific achievement, embodying a broader vision of democratizing access to healthcare advancements.
Additionally, in terms of quality of remote blood collection, Berthier recognizes that this hinges on thoughtful design — encompassing the blood collection system and methods for shipping samples to laboratories. Through careful design, Tasso has demonstrated that remote blood tests can match the quality of standard venous blood tests. However, Berthier maintains transparency, acknowledging that not every test can be seamlessly transitioned to a remote model, and decisions must be grounded in published and peer-reviewed data.
Selecting the appropriate sample collection technology is pivotal in ensuring the success of a program's shift toward patient-centric blood collection. Tasso's technology platform possesses versatility, offering devices optimized specifically for collecting dried blood or liquid blood,. The starting point, as Berthier suggests, involves determining the accuracy of different solutions through rigorous testing.
"We’ve designed a technology that’s very versatile on purpose. Typically, where we like to start is to really figure out, of all of our solutions, which ones provide great accuracy," explains Berthier. Once a range of solutions is identified, the decision-making process extends to considering operational factors and logistics to streamline implementation effectively.
The logistical aspect of transporting samples in patient-centric models requires a customized approach based on geographical considerations. Berthier emphasizes the need to align transportation methods with patient habits and regional logistics infrastructure. "It’s really a customization based on the geographical area we work in," he says.
In regions where established logistics companies like FedEx®, DHL, or UPS® are prevalent, home pickups may be the preferred method. In contrast, in areas with less developed logistics infrastructure, collaboration with local partners becomes essential. Berthier provides insight into Tasso's adaptability, stating, "We have a lot of sampling being done in countries like Thailand where there’s not a very established DHL logistics infrastructure, so we have to work with local partners and integrate into local habits."
Ensuring the seamless integration of patient-centric blood collection into existing protocols necessitates a robust validation process. Berthier simplifies the bridging process, stating, "Bridging is a pretty simple process where you recruit a certain number of patients, usually somewhere in the orders between 20 and 40, and you collect blood using the traditional method and the new method." This comparative approach verifies the comparability of results, a crucial step in gaining confidence in the reliability of patient-centric methodologies.
As part of the bridging process, Berthier highlights the importance of considering the stability of samples during transportation. "Part of bridging also has to consider the stability of samples. We simulate temperature fluctuations that would represent where the test would be implemented," he explains. This meticulous validation, endorsed by regulatory bodies like the ICH or the FDA, ensures the accuracy and stability of remote blood collection methods.
Tasso's commitment to patient-centric sampling extends beyond technology. Berthier describes the company's chain of custody monitoring system, a digital infrastructure that integrates with logistics partners and ensures end-to-end tracking of samples. This comprehensive support includes coordinating pickups, communicating data, and developing shipping solutions to maintain sample integrity. Tasso's logistical services aim to minimize the complexities associated with patient-centric blood collection, offering a holistic solution for research programs.
Berthier's vision for the future of patient-centric blood collection centers on democratizing clinical study participation. He envisions a future where geographical limitations and time constraints no longer hinder individuals from contributing to research. Additionally, he foresees a shift towards personalized healthcare, enabled by frequent monitoring of individuals' health. This evolution from sparse, distant data points to continuous, personalized monitoring holds the promise of making drug development and research more inclusive and impactful.
The transition from traditional site-based blood collection to patient-centric sampling represents a pivotal moment in the evolution of clinical research. Berthier's insights, drawn from the transformative work at Tasso, offer a roadmap for scientists, clinical trial operators, and pharma innovators eager to embrace this paradigm shift. The emphasis on transparency, data integrity, and comprehensive support underscores the viability of patient-centric blood collection across diverse programs. As the healthcare landscape continues to evolve, the adoption of patient-centric sampling promises to unlock new dimensions of understanding in disease physiology and human health.Learn more and view the wide range of remote sampling solutions offered by Tasso, here