Over the past 20 years or so, without much fanfare, clinical research has undergone a remarkable free-market conversion. Until the early 1990s, most pharmaceutical research on human subjects was conducted by physicians in universities and teaching hospitals. (The FDA, which must approve drugs before they can be marketed, doesn’t conduct clinical trials itself.) However, pharmaceutical companies have been in search of cheaper, more efficient venues and today about 70 per cent of clinical trials take place in the private sector, often in the offices of private physicians or at dedicated sites. Clinical research has become a multibillion-dollar global industry, spawning spin-off businesses that barely existed 25 years ago, from patient recruitment firms and medical communication agencies to for-profit research ethics boards. The most important new players are contract research organisations (CROs) such as Parexel, Quintiles, PPD and Covance, which have built themselves into corporate giants by taking up the management of clinical trials. The research that many of us used to imagine as a humanitarian enterprise, carried out by selfless scientists and funded by Pink Ribbon campaigns and ‘Race for the Cure’ marathons, is actually a thoroughly Taylorised corporate system, outsourced and streamlined for maximum efficiency.
It is striking just how little is known about the new clinical trials industry. Partly this is because it is so widely dispersed. Back in the old days, if you worked in a medical school or teaching hospital, you could often get a feel for a clinical trial simply by walking down the hall. Now you might need to go to India or Uzbekistan. Even if you restricted yourself to domestic studies, you would log a lot of miles trying to visit all the various stations in the production line. The trial itself might take place at fifty different sites, ranging from Ivy League teaching hospitals to a business park near Toronto airport. The ethics committee approval would probably come from Olympia, Washington; the subject recruitment could be managed in Dallas, Texas; and the trial results might be written up in Princeton, New Jersey. It is no wonder only industry insiders seem to know exactly what is going on. When Bloomberg reporters discovered that SFBC International was paying immigrants to be test subjects in a dilapidated former Holiday Inn in Miami, SFBC had recently been named one of the best small businesses in America by Forbes magazine. The Holiday Inn testing facility was the largest in North America, and had been operating for nearly ten years before inspectors noticed there was anything wrong.
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