POCT in clinical trials: why and how suitability is growing for CROs and research teams

Point of care testing (POCT) is increasingly recognised as a viable and positive choice for CROs, sponsors, and research organisations looking to drive the best possible trial outcomes and patient experiences. But why is that trend moving in such a positive direction? And when can the use of POCT be most advantageous for scientists and medical professionals?

POCT devices have been used in pharmaceutical clinical trials since 1995, giving them a long track-record of success. They typically provide test results in as few as three minutes, without the need for a centrifuge – shaving days off processing times while simultaneously facilitating the identification of potential trial participants by on-site sponsors.

Today, as their availability and effectiveness continue to expand, they are primarily used for one of three different applications. POCT devices are well suited to pre-screening. They can aid and assist appropriate dose adjustments for patients who need constant monitoring. And they can prompt crucial study interventions where necessary.

The nine leading benefits of using POCT in clinical trials

While the applications for POCT devices are often familiar, CROs and research teams opt to use them for a range of different reasons. They offer several compelling benefits, including:

1. Reducing screen failure rates
POCT has been proven to help doctors better qualify patients for trial participation. In one instance, Woodley Trial Solutions supported Phase II of a large chronic kidney disease trial by providing POCT equipment that saw screen failures reduce by 50%. 

2. Immediate results access
Even processes that appear relatively fast can often be improved, such as when equipment supplied by Woodley Trial Solutions accelerated the availability of results from 60 minutes to just 15 minutes. If a trial is sending patient samples away to a central laboratory and waiting days for results, the difference in using POCT equipment is enormous. For adaptive DCTs, this is a critical advantage. It allows dosages to be changed as needed and facilitates timely study interventions.

3. Improved patient centricity
By minimising sample collection (no more drawing of multiple vials of blood, which is major positive for paediatric and elderly patients) and improving patient convenience, POCT increases both patient engagement and recorded satisfaction levels. Phlebotomist-, nurse-, or patient-executed tests can be completed at any location.

4. Lowering trial costs
Recruiting trial participants is always expensive, but it is three times more expensive to replace and recruit a new patient midway through a trial. By increasing patient retention, POCT plays a vital role in effective budget management.

5. Increased participant diversity
POCT is a critical tool in enrolling under-represented patients. By expanding a trial’s diversity and inclusivity participant ration, POCT equipment also helps CROs to ensure they meet the new US mandate for Phase III clinical trials.

6. Sample stability
During transportation, samples can be easily mishandled. POCT testing eliminates the possibility of couriers losing, damaging, or ruining important patient samples.

7. Advanced connectivity
POCT enables rapid data collection and timely data submission to both the trial database and any relevant electronic medical records.

8. Expanded geographical access
POCT technology can be transported to remote locations, such as rural areas in Africa or the Middle East, with relative ease. This significantly broadens the potential reach of your trial.

9. Accelerated trial timelines
Some clinical trials can have monthly running costs reaching into several million dollars. When time is money, reaching a trial conclusion either on or ahead of schedule is a significant advantage that benefits both the sponsor and the patients.

The future of POCT in clinical trials

POCT is not a golden bullet in every situation. Care should always be taken to consider the wider context. For example, if your test could potentially unearth major health concerns where emotions need to be managed with sensitivity, both clinicians and patients may prefer a more gradual process.

But for many therapeutic areas – including chronic kidney disease, oncology, infectious diseases, and cardiometabolic diseases – POCT can be incredibly useful to ongoing research efforts.

Currently, more than 150 analytes and biomarker tests can be conducted using POCT.  Many common tests as well as panels are currently available, including CBC and common haematology tests, diabetes and metabolic testing, comprehensive chemistry panels, lipid panels, kidney (renal) function tests and panels, liver (hepatic) function tests and panels, blood gas and electrolytes, cardiac markers, infectious disease testing, anti-coagulation testing, CRP, eGFR, and HbA1c.

Future developments are likely to drive significant further growth, with POCTs capable of identifying Alzheimer’s disease biomarkers among the potential advances coming relatively soon.

Whatever your next clinical trial, it is worth investigating the capabilities and suitability of POCT, which can help your patients, your sponsors, and you as a research organisation to all achieve your objectives quicker, cheaper, and more conveniently than ever.

For help and assistance in identifying and sourcing appropriate POCT devices for your next trial from our in-house team of biomedical scientists, contact our friendly, knowledgeable team today.