Evaluating the Potential of Point-of-Care Testing in Clinical Trials

Point-of-care testing (POCT), such as tests for pregnancy, oxygen concentration, and glucose, has been used for many years as part of clinical trials. As clinical trial sponsors recognize the need to reduce patient burden and optimize patient engagement, POCT can provide some unique benefits. 

From an investigator site perspective, POCT devices allow for immediate return of results which can be used for early screening and to determine eligibility quickly. For patients, easy-to-use devices can allow trial participants to generate lab results from the comfort of their homes and within their day-to-day routine. 

As POCT technologies advance, patients in rural or remote areas may be able to participate in clinical trials that may not otherwise be feasible.

With the rapidly changing and challenging research and development landscape, drug developers are examining a broader scope of innovative and complex POCT applications to help improve trial outcomes and further shift the care paradigm. Below we share a few examples where POCT applications are providing value or have potential to improve outcomes. 

Single visit screening and trial enrollment

In recent years, more complex POCT devices have been made available at sites to screen and enroll patients in a single visit, helping to reduce screen failure rates through a pre-screening step and providing results to lab experts quicker. 

For example, for a therapeutic influenza study, patients required to be diagnosed with influenza prior to enrollment may go home after a screening visit and become sick, preventing them from getting back to the site to enroll. The availability of an influenza A/B POCT lab device is helping sites both screen and enroll patients within one visit, removing this obstacle. 

In global chronic kidney disease trials, POCT is used to obtain estimated glomerular filtration rates and urine albumin-to-creatinine ratios during pre-screening. This capability allows sponsors and sites to reduce screen failure rates by ruling out participants before a costly screening process. 

Evaluating applications of point-of-care testing

As devices become more sophisticated in design, including miniaturization and improved instrumentation, the goal is to enable faster results without compromising data quality and critical patient outcomes. There are several noteworthy POCT applications currently available. 

Immunoassays

Immunoassay-based testing has long been used in investigator site settings, testing for infections like Strep A and Influenza A/B. 

Scientific and technology advances have recently enabled the development of additional POCT devices able to provide results for infections such as RSV and malaria. These advancements are crucial to further the reach of clinical trials, enabling access to at-risk patients (e.g., elderly) and those in remote areas. 

Chemistry

Much like glucose monitors used by patients with diabetes to monitor glucose levels, lipids are another set of analytes available through rapid result POCT devices. They can provide immediate results for tests such as total cholesterol, triglycerides, HDL and LDL, which can aid in the screening or monitoring of critical cardiovascular disease. 

Hematology

The availability of hematology results from a POCT device can be critical for monitoring patient health. Methemoglobin testing via a POCT device enabled a study to progress checking red blood count values at regular intervals, providing critical data to the site on the investigational medication’s impact on the patient’s blood.

More to come for POCT

While many of the devices available today may strictly be used in the clinical setting, there is potential for at-home application. As innovation in POCT continues to support and enable clinical trials, industry leaders and stakeholders will determine approaches for clinical trial integration of these critical devices. 

We will continue to push the boundaries, whether it be for more complex testing enabled in a near patient setting, at-home use, via mobile phone applications or other ways to improve the patient experience and address ongoing challenges in R&D. 

The promise of next-generation POC testing can improve clinical trials in many ways.