Pharma outsourcing lowers costs but has significant downsides, according to the New England Journal of Medicine (and reported by the New York Times).

According to the NY Times, an article about the globalization of clinical trials published in The New England Journal of Medicine ”raises questions about the ethics and the science of increasingly conducting studies outside the United States — when the studies are meant to gather evidence for new drugs to gain approval in this country.”

Read the complete article here.

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• How to Lure Clinical Trials Back to the U.S. (blogs.wsj.com)

Whether a clinical trial is being conducted in-house or in collaboration with a CRO, wisdom is the key to ensuring success.

According to Deborah Manzo, Global Head of Clinical Trial Operations at Novartis Vaccines & Diagnostics,

“Having the ability to either learn from… experience yourself or from hearing about another situation builds wisdom. Sometimes a person can have 10 years experience and does not get it. Others have five years and are head and shoulders above.”

Experiences, both good and bad collected over years of conduct­ing clinical trials are the only way to develop the wisdom that allows an individual to manage a clinical trial with precision and ultimately, cost-efficient, and safe drug development- Inside Outsoucing

With respect to running clinical trials, Deborah offers the following bit of wisdom:

“A well-run clinical trial has risk management in place from day one, whether it’s time line, quality, or budget; to consider it well run, one must be constantly thinking about alterna­tives a few steps ahead.”

Source: Inside Outsourcing, November 2008