Conduct Adaptive Trials

USE CASE

Make informed decisions and adapt on the go.

Our products automatically track each participant’s medication intake patterns and adherence to the protocol. This enables protocols to be modified in real-time according to pre-established criteria.

What if you could identify non-adherent participants early in a study using a short course of placebo? They could be excluded from consideration, or trained for adherence before being enrolled in an intent to treat trial. The result would be considerable savings, as increased data accuracy leads to more convincing outcomes.

Solutions

Automatic Interventions

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.

Stratify by Adherence

Our software includes powerful tools for sorting and filtering participants based on numerous adherence dimensions. This enables you to create segments and cohorts based on the criteria for your adaptive protocols.

Specific Benefits

Targeted Education

After identifying non-adherent participants, use CertiScan’s automated messaging systems or your own resources to coach and counsel them towards improved adherence.

Informed Enrollment Decision

Use data from a preliminary placebo course to identify participants who show high adherence to a protocol, and who are therefore likely to produce higher quality data in an intent to treat trial.

Adjust Outcome Measures

Apply statistical techniques such as covariance analysis to see if there is an adherence effect and use our adherence data as a parameter, in order to better understand efficacy, side effects, and more.

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.

Fewer Participants, Same Power

Basing final PK and PD analysis on a more selective group of highly adherent participant can yield the same power despite having a smaller number. This selective group can be achieved either by adapting enrollment or by stratifying data post hoc.

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.

Learn More about the Products
that Power our Solutions

Med-ic®

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.

eCap™

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.

CertiScan® Platform

Consumer-quality software for clinical trials. Securely store, analyze, and action the data from smart packaging and other adherence devices. The CertiScan Platform includes web portals, mobile apps, developer tools, and a secure, central cloud.

Did You Know?

There is increasing industry acceptance of adaptive trials that allow for intra-trial correction. This is due to a combination of regulatory pressure, statistical advances, and technological advances. If you are new to adaptive trials or concerned about implementing an adaptive methodology, reach out and let our industry experts walk you through.

Applying adherence monitoring to an adaptive trial in multiple stages can have compounding positive effects. At each level of adjustment, there will be a greater chance of making the correct statistical decision. Regulatory approval of effective INDs will be quicker, as will rejection of ineffective INDs. In both cases, the cost savings will be tremendous.

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.

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.

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