Go West: Trends in Emerging Nations’ Clinical Trials

     

“Go West, young man.” In the mid-19th century, those words sent a generation beyond the Mississippi to seek their fortunes in America’s interior. Today, entrepreneurial men and women are seeking similar opportunities in emerging markets throughout the world.

For pharmaceutical companies, that means conducting clinical trials in Asia, South America, and Africa. Reasons include better patient access, the need to cut costs, and increasing interest in orphan diseases and unmet medical needs. Regardless of the trigger, however, the logistics concern is the same. Manufacturers must ensure temperature stability for clinical trial products shipped across lengthening supply lines.

Packages can be diverted, rerouted, stranded by disasters, left on the tarmac, sit unattended during holidays, delayed by paperwork, and even be opened by overzealous inspectors. The list of potential pitfalls is long and, sometimes, even the best packaging needs recharging.

The consequence of not knowing about temperature excursions may allow drugs that became ineffective or unsafe to enter clinical trials. For example, as the June Department of Health and Human Services (DHHS) report, "Vaccines for Children Program: Vulnerabilities in Vaccine Management" points out, temperature excursions inactivate vaccines, putting recipients at risk. That’s true for other therapeutics, too. The other major risk is a failed trial, in an environment in which clinical development costs $1 billion or more. (Forbes estimates those costs to between $4 and $12 billion when failure rates are considered.)

Comprehensive environmental monitoring can reduce those risks.  Visible indicators and labels alert handlers that the package is being monitored, and temperature indicators, monitors, and loggers can be deployed so shippers know whether the cold chain is broken. Analyzing their data helps shippers recognize patterns, discover packaging issues, or identify challenging routes or carriers, so issues can be resolved and trials can run more smoothly.