Monday, June 4, 2012

Health

The Tribulation of Trials

By Bernadine Healy
Posted 3/26/06
Page 2 of 2

Then who goes first? For most first-in-human studies, it's healthy volunteers who step up to take the risks with absolutely no medical benefit to themselves. But the hazard is tempered by proven safety in animals, the promise of a few days of R&R, watching TV, or playing pool, with an honorarium of a few hundred or a few thousand dollars tossed in. But if the risks become high-stakes roulette with a ticket to the ICU or worse on the table, no amount of psychic return or cold cash will do, and good drugs could pile up at the crossroads.

We all have a stake in what's happening in Britain. And development of technology that simulates human systems to test drugs before human exposure now takes on some urgency. The FDA just this month announced a new Predictive Safety Testing Consortium for companies to share technology that would more reliably predict human safety before drugs enter clinical study. The London event only highlights its importance.

Look into your own medicine chest. Walk the corridors of any hospital. Standing silently behind every one of our therapies is an army of human volunteers who have gone first or gone early. They have courageously taken risks for all of us, and in their hands is tomorrow's medicine.

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