Apparently we’re looking overseas for more than just customer service:
“Twenty years ago, drugs were dropping the cardiac mortality rate from 20 percent to 15 percent,” says Dhiraj Narula, medical director of Quintiles ECG, a contract-research firm that organizes trials for major multinationals. “Today we’re looking at drugs that will take you from 6 percent mortality to 5 percent. To prove an effect that subtle, in a way that’s statistically robust, you need a lot of patients in your sample.” One cardiac drug study was conducted on a whopping 41,000 subjects.
The result is a bottleneck that Narula argues is impeding the arrival of important cures. Herceptin – an exceptionally effective breast cancer drug – languished in trials for years because its maker, Genentech, reportedly couldn’t recruit enough patients to test it.
Like many in the pharmaceutical industry, Narula believes that the solution to the slow pace of drug trials lies in outsourcing. As many as half of all clinical trials are already conducted in locations far from the pharmaceutical companies’ home base, in countries like India, China, and Brazil. And many industry analysts expect the market to skyrocket, particularly as expanding libraries of genetic information increase the number of drugs coming out of the lab. The consulting firm McKinsey calculates that the market in India for outsourced trials will hit $1.5 billion by 2010.