In recent times, the process is outsourced and often not conducted at medical centers...the outsourced companies are paid to recruit physicians, who's pay in turn depends on the number of patients they recruit...this can be both good and bad...good for a patient and physician looking for a potential treatment plan when others have failed, but then there's the other side of the coin as well...some processes involve a complete quarantine to participate...the higher the risk, the higher the pay out for the human lab rat...and many volunteers are not always 100% honest about past health issues...and all personal information is kept confidential due to government rules and regulations...and now there is a big call for more regulation and involvement of the FDA....BD
Department of Health and Human Services concluded that FDA officials had no system for identifying all ongoing clinical trials. The report also noted that the FDA had checked fewer than 1 percent of the nation's estimated 350,000 testing sites, which isn't all that surprising when you consider that there are only 223 inspectors.
It gets worse. Most of the inspections focused on verifying data after a clinical trial had been completed, and just one in four looked at trials in progress. What's more, 68 percent of the serious problems inspectors identified as needing official corrective action were later downgraded, mostly to voluntary compliance, by other FDA officials. In those cases, the FDA isn't required to follow up to see if the problems were addressed.
"You had to take a pill and didn't know if it was the steroid or a placebo," he says. "Right after I stopped taking it, I had a chemistry test and bombed it. I couldn't concentrate. I was on the real thing."
Two decades ago, 80 percent of drug-company trials were conducted at medical centers with academic ties. By the turn of the century, that number had fallen to less than 40 percent, notes Harvard medical school's Marcia Angell, M.D., in her book "The Truth About the Drug Companies: How They Deceive Us and What to Do About It." In an effort to streamline operations and increase profit, the vast majority of pharmaceutical firms have outsourced their trials to third-party, for-profit testing centers known as contract research organizations (CROs).