October 24, 2014

Drug Trials

Aftermath of a Drug-Testing Firm

What happened to SFBC International, a once fast-growing drug-testing firm in Miami?

Amy Keller | 3/1/2007


ResearcH Project: Lisa Krinsky (above) "built this company from nothing, and you now have people running her business that are effectively the people she brought on after she bought out their less successful companies," Krinsky's lawyer says. In 2005, Fortune magazine named Krinsky the 15th-richest executive at a fast-growing small public company. Photo: Daniel Portnoy

Twenty-five years ago, pharmaceutical companies and academic research institutions that were developing drugs typically did their own testing -- including conducting human trials as part of the federal approval process. But by the 1990s, as pharmaceutical companies streamlined their operations, they increasingly turned to contract research organizations to test drugs in development for effectiveness and for side effects.

Typically, those contract research organizations (CROs) operate facilities where they solicit and sometimes house the volunteers who participate in the drug trials. Depending on the trial, volunteers can earn from several hundred to several thousand dollars for taking part. They come from all walks of life, ranging from the sick to the healthy, from physicians wishing to further their research efforts to poor immigrants willing to turn their bodies over to science in exchange for money.

Some industry experts say contract research organizations' safety standards are just as rigorous as those of the pharmaceutical companies that run their own trials. CROs have a comparable safety record, says Ken Getz, a senior research fellow at Tufts Center for the Study of Drug Development. "If anything, the CRO industry acts as an additional layer of oversight because they're once removed from the (drug) sponsorships. The CRO doesn't have a stake in the success or failure of the investigational treatment."

Questions have arisen, however, as the volume of clinical trials has increased. Do patients -- particularly immigrants who may have limited English-language skills -- really understand the risks described to them in the informed consent process required by the federal government, for example? Additionally, institutional review boards, the bodies that oversee human trials to ensure they are safe, have complained to the federal Food and Drug Administration that they are being stretched thin as the volume of testing increases.

Meanwhile, the CRO industry has become a huge business. In 2005, $14 billion of the $56 billion that pharmaceutical and biotechnology companies spent on research and development went to outsourcing services offered by CROs. Market analysts predict that could grow to $20 billion by 2010.

Tags: North Central, Healthcare

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