Chronic kidney disease (CKD) is on the rise, largely owing to an aging population, with many elderly individuals often having a number of risk factors for the condition, including obesity, diabetes, and hypertension. In fact, according to the CDC, roughly 15 % of US adults suffer from CKD,1 making it imperative for the development of new treatments to help preserve kidney function. Decentralizing clinical trials offers a way to help accelerate drug development for CKD, and the role of point of care testing (POCT) is already proving to be a cost-effective and patient-friendly method to support this approach.
What are the benefits of POCT in decentralized clinical trials?
POCT is certainly not a novel idea in drug development, with devices monitoring blood glucose and oxygen having been used in clinical trials for many years. More recently, however, the number and complexity of pieces of equipment being implemented into clinical trials has expanded, further eliminating the reliance on a central lab for testing. So, what exactly are the benefits of using POCT in decentralized trials?
1.Increased demographic representation – POCT allows trials to be conducted on participants from populations that would normally struggle to travel to a centralized site – including the elderly, the more vulnerable, or immobile patients – increasing the robustness of the results. Similarly, testing can reach hard to access regions, potentially where the health conditions of interest are most prevalent, such as monitoring malaria in areas of Africa.
2.Optimized patient recruitment – being able to pre-screen a potential patient at an investigator site, confirm their eligibility, and enroll them, all in a single visit, is an enormous time saver, and can significantly reduce screen failure rates.
3.Improved time to results – not having to send samples to a central lab increases speed and efficiency, and often reduces the cost of testing within a clinical trial.
POCT in CKD clinical trials
For CKD trials specifically, POCT is playing an increasingly valuable role, especially in prescreening patients, where we have already helped our clients to significantly reduce screen failure rates. For example, we recently supplied a range of POCT devices – including urine analyzers, and creatinine and eGFR meters – to a clinical trial with hundreds of different sites all over the world. This included not just equipment delivery, but also in-depth staff training and ongoing technical support, which proved pivotal in making the enrollment process more efficient, and providing fast and consistent reporting of results.
Value in real time
The benefits of POCT in CKD trials, however, extend far beyond workflow and economic efficiencies, with the real-time collection of data providing a great deal of value, even on occasion for the patients themselves. Patients with CKD often have a range of comorbidities, making their inclusion into a clinical trial very complex, subject to a range of criteria. POCT handles this assessment with ease but can also detect values drastically out of range that might indicate acute problems requiring immediate attention. Seeing the results in real time like this can potentially prevent something serious happening.
For any trial, of course – whether it’s for CKD or any other condition – it’s important to keep sight of the regulatory landscape. While POCT clearly has great advantages, it’s easy for CROs and sponsors to fall foul of the rules and regulations governing these technologies, which can often differ between the various countries involved in the clinical trial. That’s why we keep abreast of the rapidly changing global regulations, ensuring that the right devices are suitable for each site – regardless of the region.
What does the future hold?
With such clear benefits of POCT and decentralization in CKD clinical trials, we’re excited to see where the adoption of these new technologies could take patient healthcare. Imagine a world where getting diagnosed and receiving treatment was as easy as walking into your local pharmacy, POC technology transmitting your data straight to a GP, then walking out with a prescription for treatment – all within ten minutes. It might not be quite there yet but, if the progress being made using POCT in CKD clinical trials is anything to go by, then that future image of healthcare can’t be too far away.
1.Centers for Disease Control and Prevention, 2021, Chronic kidney disease in the United States, 2021. Available at: https://www.cdc.gov/kidneydisease/publications-resources/ckd-national-facts.html (Accessed: 11/05/2022).
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