Information Mediary Corp

eCAPV30 ROI Med-ic Med-ic eCap eCap

"As long as the same methodologies are applied equally among all groups, I can't see an issue with introducing methods to monitor/improve compliance. As an aside, the FDA does not treat NIDA differently from a pharma with respect to rulings, communication, etc.

In the trials that we (NIDA) run, either independently or in collaboration with pharma, we routinely incorporate adherence measures. We also strongly encourage our grantees to do the same."


Phil Skolnick, Ph.D., D.Sc. (hon.)
Director, Division of Pharmacotherapies & Medical Consequences of Drug Abuse
National Institute on Drug Abuse
 

If Hippocrates1 knew that patients are noncompliant with their treatment and nearly every clinician since would agree, why does the “elephant in the room” continue to be ignored?

A clinical trial is simply an exercise in optimizing a signal-to-noise ratio. The signal is the desired clinical effect;the noise everything else that obscures the signal. Poor patient compliance is a major source of noise that can now be measured and controlled to increase the accuracy of a trial.

Drugs don’t work in patients who don’t take them. - C.Everett Koop, Surgeon-General

Why are trials not all monitoring compliance, as suggested by Bradley Efron in 1998? The short answer is that trial planners focus on the initial cost of electronic compliance monitors (ECMs) such as IMC’s Med-ic® and Proteus’ Discover®and overlook the tremendous ROI they provide by accelerating trial fulfillment.

At some point, perhaps not in the far future,it will seem as wrong to run a clinical trial without compliance measurement as without randomization. - B. Efron, Statistics In Medicine, 1998(17), 249.

Compliance data are even more important for adaptive trials due to the increased number of decision points increasing the probability of a Type I error, and the smaller signals’ vulnerability to being obscured by noncompliance (and other) sources of noise.

Pray, Mister Babbage, if you put the wrong figures into the machine, will the right answers come out? - Charles Babbage, Polymath, 1864

In addition to providing more accurate data, ECM is a powerful tool for monitoring subjects’ medication-taking behaviour during a clinical trial and providing data to increase the power of the design. This results in cost savings due to the ability of smaller sample sizes to show statistical significance (drug effectiveness) and earlier regulatory approval with longer time on patent protection. With a well-designed blister package equipped with an electronic compliance monitor and good subject education, poor patient compliance can be changed from a liability to an asset with enormous return on investment.

[1]Hippocrates of Cos, Decorum, XIV

Compliance data are used in a number of ways:

  1. To screen patients for compliance characteristics prior to enrolling them in a trial.
  2. To motivate subjects to be more compliant as they progress through a trial. It can be shown that increasing compliance by x% allows for a reduction of the trial’s N by 2x% without changing the study’s power. Fewer subjects means faster regulatory approval and longer patent protection. Hence the large ROI.
  3. To assess subjects’ compliance post hoc. Data mining can throw light on many aspects of subject behaviour and can be tailored to the interests of the sponsor. In one trial it was found that 40 percent of subjects deblistered their medication, something that would have otherwise gone undetected. The problem was solved by developing a more user-friendly format. Another trial showed no significant difference between treatment groups by the primary outcome analyses. The subjects were stratified post hoc according to their compliance and the drug was highly effective for those subjects who actually took it as prescribed.
  4. ECM can serve as a REMS (Risk Estimation and Mitigation Strategy) for trials where noncompliance can have more serious consequences than those associated with simple data inaccuracy. Opioids, for example,can result in fatal overdose when taken to excess, and these drugs are often diverted for sale on the street. ECM detects the deblistering that might suggest such activities and allows the investigator to intervene.
  5. ECM can detect subtle medication-related bias effects that can lead to erroneous conclusions about drug efficacy. And which would otherwise go undetected.

 

For details about why Pharma finds value in ECM, please refer to our ROI calculator at http://www.informationmediary.com/roi/roi-calculator

 

 
New Research Paradigm:

Apple’s Tim Cook wants to stand Clinical Research on its head and, if anyone can disrupt Clinical Research, it is probably Apple. Med-ic smart blisters give the research team instant access to patient adherence data and the ability to coach patients to be compliant with their medication. The old argument about not wanting clinical trial subjects to be more compliant than those patients who will eventually use the medication in the real world is now officially relegated to the dustbin. Post hoc data “clean up” will one day soon be as irrelevant as dialling a rotary phone. Some Big Pharma research teams are already embracing compliance data; others are ready to jump in. Soon, clinical research will not be defensible without smart blisters, compliance data and full visibility. See www.med-ic.com for details.

 
The World's Most Accurate Low-Cost RFID Sensors

Information Mediary Corporation (IMC) manufactures a range of intelligent devices that includes the award-winning Med-ic® and eCap™ electronic compliance monitors (ECM©s). ECMs address the problem of poor patient compliance with prescribed medication by monitoring medication taking behavior in real time.

To complement its compliance-monitoring devices, IMC develops data systems, displays, and statistical analytical techniques to facilitate a wide variety of related applications. IMC also carries out R&D for custom applications involving the integration of electronics, sensors, printed sensor grids, NFC, RFID, Bluetooth and other technologies.

IMC has developed low-cost, single-chip RFID and NFC sensor technology, RFID readers, and printed electronics. Strict validation and adherence to GMP and ISO9001 processes ensure these products exceed pharmaceutical and logistics standards.

For further information, please see the following product descriptions.

 

The Med-ic® Electronic Compliance Monitor (ECM©) is a revolutionary solution to the problem of patient non-compliance with prescribed medication. Developed by smart packaging experts IMC, the Med-ic ECM tracks medication usage for any blister packaging format without active patient input.

Read more...

 

eCAP™ is an extension of the Med-ic® smart package concept to the medication vial. In conjunction with Rexam, a global leader in the design and manufacturing of pharmacy vials, IMC's eCAP provides a flexible, dynamic, reliable and cost-effective compliance solution.

Read more...

 
Certiscan

The CertiScan® RFID Reader and associated Software is IMC's proprietary, secure solution to downloading Med-ic® ECM© data. The compliance data captured by the reader are stored on a PC where they are displayed via an intuitive interface, allowing the clinician to interact knowledgeably with the patient around medication-taking behavior. CertiScan is compliant with 21 CFR Part 11.

Read more...

 
eCap

IAP Labs is a division of Information Mediary Corporation and was formerly known as XINK Laboratories Ltd., which was acquired by Henkel (ex- National Starch) on June 1, 2006. IAP Labs is dedicated to the development of intelligent and active packaging technologies. IAP Labs Inc. provides development, prototyping, testing, and production of intelligent packaging, printed electronics, printed sensors, and pharmaceutical smart labels from its Ottawa-based facilities (IAPLabs.com).

Read more...

 

Value Proposition

See Us At

Data & Technology in Clinical Trials USA 2017
Philadelphia
Feb 21 - Feb 22 2017
Differentiate with data. Use technology and patient insight to make trials your competitive advantage.
Interphex Japan 2017
Tokyo Big Sight
Jun 28 - Jun 30 2017
With more than 1,000 exhibitors, INTERPHEX JAPAN is the world's leading and firmly established B-to-B trade show specialized in Pharmaceutical R&D and Manufacturing.