Dashboard delivers real-time view of patient drug adherence

By Jenni Spinner

- Last updated on GMT

(Image: Elucid Digital Health)
(Image: Elucid Digital Health)

Related tags Clinical trial Contract research organisations Pharmaceutical drug Clinical research Patient centricity

Elucid Digital Health’s Pill Connect is designed to enable CROs and pharma companies to monitor patient adherence during a clinical trial.

Pill Connect is a drug dispensing system engineered to give contract research organizations (CROs) and their pharmaceutical clients the ability to track adherence across an entire trial. The information can be brown down by the overall trial, country, site or even down to individual patients.

The dashboard is automatically generated by dispensing of a pill or tablet via use of the Pill Connect cap, made to fit atop any standard pill bottle. The patient receives a reminder on their smartphone at the time the medication should be taken; they then touch the ‘dispense’ button on the screen, which ejects the pill or tablet from the bottle; a signal then is sent indicating it has been dispensed.

If for whatever reason a patient fails to respond to the alert, a reminder text or direct call can be sent to find out why. If needed, the patient can respond to the alert by tapping on the screen that they don’t feel well or that the pills are making them feel unwell.

The information generated by the Pill Connect system can be customized to show a broad range of data, as requested by the CRO or pharma company.

James Burnstone, Elucid Digital Health CEO, told Outsourcing-Pharma that ensuring adherence, and keeping track of nonadherence, is important to clinical researchers.

Accounting for subject nonadherence and eliminating inappropriate subjects in clinical trials are critical elements of a successful study. Nonadherence can increase variance, lower study power, reduce the magnitude of treatment effects, confound safety and efficacy signals​,” he told us, citing a recent article published in the Journal of Clinical Pharmacology.

And, Burnstone explained, adherence issues create a range of pressing concerns during clinical trials, for the CROs and pharma companies as well as for the patients.

As trials & treatment progress, some patients still stop adhering to the protocol and this creates poor data in trials, wasting time and costs, and ultimately it’s going to impact the patient’s recovery. In addition to missing doses, accidently double dosing can cause toxicity and under dosing can lead to drug resistance​," he said.

Additionally, researchers should also seek insight as to why patients miss doses, Burnstone encouraged.

In addition to monitoring adherence and trying to improve it, it’s important to understand why patients may choose to miss a dose; it may shed light on useful information and gives patients a voice when they may feel concerned about telling this to their clinician; white coat syndrome​,” he said. “We hope to provide this feature in Pill Connect to investigate whether patients find it easier being honest with the app and this in turn could better support adherence improvement measures​.”

In addition to a customized dashboard for CROS and pharma teams, the system can show the patients graphic feedback indicating how they are performing with their adherence and compare their track record to other trial participants.

Burnstone added the system is designed to combine performance with affordability, while helping to conserve costs and avoid waste.

We anticipate the system to cost $50 or less per patient per month​,” he said. “We look at what the system is intending to achieve which is better quality data to improve a trial and potentially less patients enrolled which could lead to large cost savings. If a trial doesn’t demonstrate required efficacy due to non-adherence, then that would be disaster for the sponsor costing tens of millions of dollars​.”

Stuart Young, CEO of site management company Panthera, said, “Confident tracking and adherence to treatment needs this type of improvement to help ensure that the power of a study is not compromised. Investigators will really like this technology and it is simple to use and understand. We need more technology in research like this which is focused on the patient​.”

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