Smart packaging in drug development: The disconnect in clinical trials

Electronic compliance monitoring packaging has been around for years, yet many pharmaceutical companies are unable to quantify the return on investment of smart packaging.

Pundits who predict the future of packaging often talk about the rise of smart packaging. What exactly is a smart package? One U.K. Web site cites examples such as time-temperature food quality labels, self-heating or self-cooling containers—any package enhanced to deliver additional consumer convenience.

One way or the other, you can bet that the single most limiting factor to the growth of smart packaging is cost. Added convenience is great, but in our price-sensitive society the ultimate convenience is affordability.

In the pharmaceutical realm, perhaps it's even harder to put a face on smart packaging. My dream is someday the consumer will have a smart package she or he can interact with to determine if the package is genuine or counterfeit. We're a long way off, I'm afraid. So what is out there today?

MeadWestvaco Healthcare Packaging offers a smart package called Cerepak, targeted for use in the clinical trial market. This package, which offers electronic compliance monitoring, has the potential to save pharmaceutical companies millions of dollars. Yet, smart packages like these have been around for 10 years with limited success. Why?

Because the cost of the package appears high compared to traditional packaging. But when compared to other data collection methods and technologies, smart packaging doesn't seem that expensive. What pharmaceutical companies need to do is to look at the value of the data over the entire clinical trial/drug launch process. This smart package can deliver savings, but it's up to the packaging experts in these companies to make the case for smart packaging at the clinical trial level.

Where are the savings? Most clinical trials today count on the patient to fill out a diary about their use of the product involved in the trial. Recent reports show that only 20% of patients actually fill out the diary within 90 minutes of taking the medication. In fact, another published report revealed that patients failed to write the truth in their diaries, over-reporting usage more than 50% of the time. Some fill out the entire diary the day it arrives! Smart packaging offering electronic compliance monitoring would reveal these inconsistencies.

Unfortunately, under the Food and Drug Administration's (FDA) "Intent-To-Treat" approach—where every participant of a clinical trial contributes data whether they follow protocol or not—flawed data is averaged in, which can result in failure of trial because patients were not exposed to the proper drug dosage. The financial loss includes not only the costs of the clinical trial itself, estimated anywhere between $19,000 and $26,000 per patient, but also the loss of commercial sales of the product since the trial failed.

Worse yet, the drug can be approved based on flawed data leading to too strong a dose being recommended initially. Patients who report compliance, but actually are skipping doses, may report excellent results. This can lead to a higher dose of the medication being approved, when in fact it is not needed, and will lead to trouble following the drug's launch.

According to Dr. Carl Peck, now retired from the FDA, "It is well established that there is a systematic flaw in dose finding during drug development that has resulted in strong evidence [that] about one in five products will undergo a 50-percent dose reduction post-market."

In other words, if you are counting on $1 billion in profits, there is a 20% chance that this projected revenue could be dramatically reduced. Smart packaging at clinical trial phase could eliminate this possibility by linking actual compliance with efficacy.

Smart packaging does not represent a new twist on an old product. For 10 years electronic compliance monitoring packaging, which accurately records non-dosing events, has been fighting to gain acceptance in clinical trials. Packaging professionals need to look closer at the evidence, and be able to make a case for these smart packages.

- By Jim Chrzan, Publisher
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