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Can Merck’s HPV Vaccine Clinical Trial Process Be Trusted?

JayaJan Pharmaceutical Research in India was one of the companies with which Merck had a contract to test Gardasil. Like most of the industry, Merck increasingly outsources its clinical trials to Contract Research Organizations (CROs) in areas of the world where trial subjects are plentiful, operating costs are low, and regulations lax. These CROs are a booming $15 billion industry whose revenues are rising at 15 percent a year. Critics point out that CROs can come with built-in problems. Conflicts of interest can arise when CROs are paid royalties only after a drug is approved rather than being paid a set fee that is independent of how safe or effective the drug turns out to be.

Inside a Contract Research Organization (CRO)

The Health Decisions central system integrates all the components in a clinical study: data collection, adaptive randomization, site payments, administrative functions, and a reporting suite. “We’ve been using dedicated study websites for reporting and coordinating for 7-10 years,” says Rosenberg. “I assumed everyone was doing this. But almost nobody else does that. From a technology standpoint, this is a no brainer. It’s the quickest, easiest, most efficient way to distribute information.”