Investigating Clinical Trials Drug Packaging
Clinical trial packaging may not seem as important as commercial packaging. After all, “nine out of 10 experimental drugs fail in clinical studies,” said Mike Leavitt, Health and Human Services secretary, in January as FDA announced new recommendations for investigational new drug studies. Why, then, invest in sophisticated packaging for experimental products that may never reach production lines?
Packaging, however, plays a key role in a clinical trial. “It is important to create a patient kit that encourages patient compliance, not hinders it,” says Steve Jacobs, president of Bilcare Inc. (Phoenixville, PA). “If compliance suffers, a study won’t show accurate results and an important, effective medication may not make it to market.”
And noncompliance is a problem. “It is widely accepted that patients participating in clinical trials are less than perfectly compliant with their medication regimens,” writes Allan Wilson, MD, PhD, president of Information Mediary Corp. (Ottawa, ON, Canada), on his firm’s Web site. “The extent to which noncompliance affects the results of clinical trials is unknown. Several factors work against the assessment of this phenomenon, principal of which is the lack of a methodology to monitor patient compliance in a noninvasive way.”
Wilson’s solution is the Med-ic ECM (Electronic Compliance Monitor), which can be used with any blister package to track medication use without patient input. The product uses sensors and printed conductive inks from XINK Laboratories Ltd. to form a smart label that records patient activity. The Med-ic ECM is now being used in a large multiple-year study of macrolide. Sponsored by the National Institute for Health’s National Heart, Lung, and Blood Institute (NHLBI), the study will be enrolling more than 1100 patients with moderate-to-severe chronic obstructive pulmonary disease (COPD).
Jacobs also sees promise in the use of electronic diaries that can guide patients through regimens and track patient behavior. The firm is exploring the use of electronic diary kits for monitoring clinical trials patients.
But for these types of solutions to really make a difference in clinical trials, it seems as though clinical trial packaging as a discipline needs more credit. “Clinical trials packaging and commercial packaging are two different worlds,” says Jacobs. “Clinical development is focused on how soon clinical data can be gathered and assessed, whereas the commercial side is thinking about scaling up production, buying supplies and equipment, and keeping eyes on economies of scale.
Jacobs wishes that these two worlds “would work together and overlap more.”
A few drug companies understand the benefits of having the departments communicate, Jacobs says. “But there is still a deeper level of understanding needed,” he says. Ideas like the electronic diary “could inspire commercial packaging, just as clinical trial packagers could benefit from more-compliant packaging.
“Packaging can positively impact the statistical outcomes of a clinical trial drug,” says Jacobs, who we’ve quoted in this issue’s feature on clinical trial packaging starting on page 28. Electronic diaries could go a step further.