Medication non-adherence is shockingly common in clinical research. Participants are typically just 50 to 65 percent adherent with their medication, and poor adherence creates numerous harms.
The highest and best use of our products is early detection of non-adherence and correction through self-discovery, education and motivational counselling. In some cases, it can even save a trial.
Solutions
Automatic Dose Tracking
We make blistered and bottled smart packaging that automatically records each dose. Doses are removed as usual and there is no burden or learning curve for the participant. Dose data can be viewed instantly (for real-time use cases), or stored on the smart package for up 3 years later (for retrospective use cases). All devices are manufactured in ISO/GMP compliant facilities.
Automatic Analysis
Each dose is classified and labeled as per your protocol: “Adherent”, “Early”, “Late”, “Extra”, and more. We identify trends at the participant, site, and study level. Data export is fast and on-demand. Web dashboards are available for study staff to monitor and review data. Staff can opt in, to be involved as they see fit. And a mobile app provides participants with informative screens and self-motivation features.
Automatic Interventions
Participants can receive mobile smart reminders. These notifications are delivered intelligently, based on the trial protocol and past dosing data. Targeted educational messages can be delivered to participants in response to particular aberrant dosing behavior. Coaching resources may be generated at the site for in-person sessions.
Specific Benefits
Protect Individual Outcomes
Drugs don’t work in patients who don’t take them. Missing doses or taking doses inconsistently can make treatments dramatically less effective.
Serves as a REMS
The FDA requires risk estimation and mitigation strategy for trials where drugs pose serious risks, such as opioids. Our solutions and automated timely interventions can form a key part of your REMS.
Reduce Post market Risk
Conclusions regarding the therapeutic dosage and side effects are often based on idealized adherence levels rather than real world levels. This can distort trial results and introduce risks that are only discovered post-market.
Prevent Unnecessary Continuation
Failure to collect and act on adherence data means trials overrecruit and track participants for longer in order to drown out the statistical impacts. This results in potentially months of delay in getting to market.
Better Phase III Go-or-No Decisions
Once safety and tolerability have been assessed, adherence data can support the go-or-no decision. The costs of equipping a phase II trial with our solution are minimal compared to the expenses and resource commitments of a phase III trial.
Prevent Abandoned Trials
Our solutions are a low-cost insurance measure against “just missing” a primary endpoint. Once data is stratified by adherence, significance can emerge and save an enormously expensive trial. Read below to learn more.
Learn More about the Products that Power our Solutions
The original smart blister package. Breaking a blister records the time and location (i.e. “8:00 a.m.” and “Day 1, Morning”). Med-ic® can be customized to work with any blister design and dose pattern.
The superior smart cap. Unscrewing and removing the eCap™ records the opening time. Several diameter and threading options are available to fit all common bottle types.
Consumer-quality software for clinical trials. Securely store, analyze, and action the data from smart packaging and other adherence devices. The CertiScan® Adherence Platform
includes web portals, mobile apps, developer tools, and a secure, central cloud.
Missing doses, taking extra doses, or taking doses at inconsistent times make it challenging to keep drug plasma levels within the desired therapeutic window. This can result in ineffectiveness due to inadequate plasma levels, or side effects due to elevated levels. Both have serious implications for the clinical trial decision-making process.
A phase II trial showed no difference between treatment and placebo groups according to the primary outcome analysis. But when the subjects were stratified by adherence, there was a highly significant treatment effect for the participants who actually took the drug as prescribed. The drug was subject to further assessment.
It is vital for trials to thoroughly measure adherence across all participant populations and all trial periods. Measuring only the first few weeks of a trial is not representative since adherence decreases with duration of therapy and aberrant use can occur at any time.
Up to 40% of patients exhibit a drug mishandling behavior called “deblistering” - they remove all pills into a bag or container for portability. This thwarts titration and harms drug stability. Detect deblistering and other
aberrant use in real-time with Med-ic® and eCap™, and help correct with CertiScan® Adherence Platform's automated mobile coaching. After interventions, deblistering rates can be dramatically reduced to 3-4%.
ROI
Our experts have modelled the relationship between statistical power, sample size and medication adherence.
Their findings? For every 1% adherence increase, there can be a 2% reduction in trial size (N) while holding statistical power constant.
Considering that many trials currently only reach 50% adherence, there’s lots of room for improvement – and tremendous ROI.
Direct Savings from Reduced N
Processing a participant is expensive. Requiring a smaller sample size could amount to millions of dollars in savings.
Additional Weeks of Patent Protection
Smaller N means a faster trial, potentially by months. This could amount to tens of millions of dollars in additional revenue.
Compensate for Low or Slow Enrollments
It can be challenging to recruit enough participants - especially for niche diseases and even worldwide. Better data means fewer patients are needed overal.
Our mission is to create adherence-focused technologies that enable safer, faster, more efficient, and more innovative clinical research.There’s an IMC solution that will transform your next trial. Don’t wait, start the conversation with our team now.We’ll reach out in order to:
