In this episode of CC Life Science, I had the pleasure of hosting Neil Spooner, the founder and chair of the Patient-Centric Sampling Interest Group (PCSIG). Neil shared his insights into patient-centric sampling and its potential to revolutionize healthcare and clinical trials.
Introduction to Patient-Centric Sampling
Neil began by explaining the concept of patient-centric sampling, which prioritizes the patient's needs over traditional methods that often inconvenience them. Traditional methods like venous phlebotomy or standard urine collection are designed with the analytical labs, clinicians, and logistical chains in mind rather than the patients. For patients, that means they have to have to take time out of their day, possibly missing work or school, to visit a clinic for sampling.
This is an added burden for patients, particularly those with chronic conditions requiring frequent testing. I shared the example of a family member, who had leukemia and needed to visit the hospital twice a week for tests. This was a significant strain not only on her but also on family members. Neil explained that patient-centric sampling offers a more convenient alternative, allowing samples to be collected at a time and place that suits the patient, whether at home or any other location.
Benefits for Clinical Trials and Healthcare
I was curious about what this approach would mean for clinical trials and healthcare. Neil pointed out that easier and more flexible sampling methods could improve patient recruitment and retention in clinical trials. It could also help gather data that is currently difficult to obtain, such as samples taken during a clinical event like a migraine. This approach not only enhances data collection but also broadens the patient pool to include those who might otherwise find it difficult to participate due to geographical or physical constraints.
Current Research and Stakeholder Engagement
Bring this concept to life isn’t just about workflows and analytical science. Marketing plays a big role as well. And I don’t just mean promotion. I mean understanding the needs of everyone involved. Neil explained that the PCSIG is actively engaging with various stakeholders to understand their concerns and benefits regarding patient-centric sampling. They are doing market research to identify key stakeholders in different use cases, such as clinical trials, therapeutic drug monitoring, diagnostics, and drug testing in sports. By having conversations with these groups, PCSIG aims to educate and address their concerns while identifying potential benefits and gaps in the current system.
Addressing the Resistance to Change
One of the significant challenges discussed was the resistance to change within the healthcare and clinical trial sectors. Neil ponted out the importance of finding passionate individuals within organizations who can champion the adoption of new sampling methods. These individuals need the support of their superiors and a network of like-minded professionals to overcome the inevitable hurdles that come with implementing new technologies.
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Technological and Logistical Innovations
We spent a little bit of time discussing sample formats and logistics. Currently labs doing routine analyses operate large analyzers that are set up for huge volumes of a standard set of tubes. Neil provided insights into the technological and logistical innovations required for patient-centric sampling. He mentioned various devices that can collect blood samples through finger pricks or from other body parts like the arm or thigh, often producing dried samples that can be mailed to labs. The COVID-19 pandemic demonstrated the feasibility of such home-based testing, showing that logistical systems can adapt to handle new sampling methods.
Impact on Drug Testing in Sports
I was surprised to hear about the application of patient-centric sampling in drug testing for sports. Chain of custody is crucial here to ensure the integrity of the samples. Neil explained that while athletes would still need to be witnessed during sample collection, blood sampling could be a more comfortable and less invasive (in terms of witnessing) option compared to urine sampling. Ultimately it’s likely to be complementary to urine testing. It does bring benefits for the athlete. It can make ongoing monitoring more practical for providing valuable data for athletes' training and health.
Sponsorship and Future Plans
Finally, we touched on the PCSIG's funding and sponsorship. Neil explained that the organization aims to keep sponsorship levels low to encourage broad participation, including startups and companies from less affluent regions ensuring that no one sponsor has outsized influence on the direction of the group. Sponsors benefit from visibility on PCSIG's platforms and involvement in the sponsors' advisory group, which helps shape the group's activities. Sponsors recently voted on nine proposed activities, and the top two priorities would soon be announced.
Reducing the burden on patients needing frequent testing alone makes this effort worthwhile in my opinion. The benefits for recruitment and retention in clinical trials and drug/health monitoring in sports are icing on the cake.
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