Commercializing clinical trials--risks and benefits of the CRO boom.

n engl j med 357;14 www.nejm.org october 4, 2007 1365 decade. They’ve been able to do so by offering greater speed and efficiency in conducting clinical trials than academic groups can, but questions have been raised about their qualifications, ethics, accountability, and degree of independence from their pharmaceutical-industry clients. Annual CRO-industry revenues have increased from about $7 billion in 2001 to an estimated $17.8 billion today; of more than 1000 CROs in operation, the four largest — Quintiles, Covance, Pharmaceutical Product Development (PPD), and Charles River Laboratories — are now billiondollar companies, and two others — Parexel and MDS Pharma Services — are worth more than $500 million each (see Fig. 1).1 This growth reflects the industry’s contribution to clinical trials: a study sponsored by the large CROs and conducted by the Tufts Center for the Study of Drug Development showed that 10 of the largest firms had enrolled more than 640,000 subjects in trials in 2004. According to the clinical-trials information company Thomson CenterWatch, CROs played a substantial role in 64% of phase 1, 2, and 3 clinical studies in 2003 (for about $7.6 billion in contracts), as compared with 28% in 1993 (for $1.6 billion) (see Fig. 2).1 But some recent events have raised questions about whether the commercialization of clinical trials, in its current form, is in the best interest of science or the public. In 2005, a Bloomberg News report revealed the inadequate conditions and minimal oversight at a phase 1 and 2 clinicaltrials unit housed in a converted Holiday Inn in south Florida and owned by the SFBC International CRO. With 675 beds, the site was the largest experimental-drug test center in North America. But SFBC’s clinical-trials director was an unlicensed physician, and its Florida research subjects, many of them poor Hispanic immigrants lured by per-trial payments, enrolled without fully comprehending the risk of injury or death and were enticed to stay in trials in some cases by “backloading,” in which the largest payments are made near the end of the trial. At an SFBC site in Montreal, a patient was allowed to remain in a trial despite having active tuberculosis; nine other trial particiCommercializing Clinical Trials — Risks and Benefits of the CRO Boom