Clinical trials are driven by hope

For the U. and other research institutions, the dream is partly about money since scientific discoveries can be extremely lucrative. And it's partly the desire to be first and best. There's little payoff for being second, Zimmerman said. Besides that, "you need a track record" to attract federal research funds and other grants. And to bring in first-class scientists to continue the cycle, he said.

The ultimate dream is to find a novel therapeutic agent with a dramatic impact on a common disease that's easy to take and inexpensive. "I think there may still be an aspirin out there," Zimmerman said.

The business of research

The first clinical trial Pharmacology Research Associates did, in 1976, was looking into the effectiveness of an antidepressant that eventually reached the market. The project involved "huge, huge amounts of money," recalled Dr. James Ferguson, the psychiatrist who founded the company, now called Radiant Research.

Currently, Radiant conducts studies ranging from Attention Deficit Hyperactivity Disorder to adolescent migraine, Alzheimer's disease, depression, diabetes, herpes, hypertension, insomnia, mild memory loss, psoriasis, sleep disorders, hives and more.

The caliber of the clinical trial at companies like his is equal to that of the academic and health institutions, he said. They're all carefully monitored, subject to on-site review and vast overview. Four times, the FDA has come in to go over records. Once, the Japanese government sent in a team. Study sponsors make more frequent quality-assurance visits.

A specific treatment may be tested at many different sites, but each must conduct the research in precisely the same way. The ethical design is identical, as are the contracts. The protocol cannot vary from site to site. Participating sites sign a Document 1572, which has teeth including possible criminal prosecution. It's a highly regulated process, Ferguson said.

Who? Me?

Privacy is a huge consideration, and names are closely protected in a clinical study. In genetic studies, for instance, the link between the patient and blood is severed.

There's a trade-off. That privacy means a participant doesn't get information about himself. If a blood test revealed a potentially life-threatening problem, there'd be no way to inform the participant. But such protections are the only way to make it work.

Occasionally, in extraordinary circumstances, the seal can be broken. Ferguson arranged it once when a baby ate his mother's study medication. They had to know if it was dangerous.

Tales to tell