Contract Research Organizations
Companies can now pick and choose populations.. .in order to get a most pronounced drug benefit signal as well as a ‘no-harm’ signal.—Former CRO chief executive (quoted in Petryna 2009: 17)
The pharmaceutical industry sponsors a majority of the 40,000 new clinical trials initiated each year and 60,000 trials ongoing at any one time and provides roughly half of all funding for clinical trial research (CenterWatch 2009). Of this research, 70-75% is done by CROs, for-profit companies that perform research and development (Fisher 2009; Mirowski and Van Horn 2005). An indicator of their rising significance is that CRO revenues increased from US$1 billion in 1992 to an estimated $27 billion in 2010.
CROs are involved in all different aspects of pharmaceutical industry research, from preclinical work through all phases of clinical research, and they perform 95% of laboratory services related to trials. According to a 2005 survey of pharmaceutical company departments that hired CROs, outsourcing serves a number of purposes. It saves costs (74%), protects the sponsoring company from risk (70%), enhances quality (67%), saves time (59%), and increases productivity (52%) (CenterWatch 2009). In addition, though not arising in the survey, CROs provide something that academic researchers leading clinical trials will not: data to pharmaceutical companies with no strings attached. The data from a CRO study is wholly owned and controlled by the sponsoring company.
CROs conduct trials with one eye to the drug approval process and the other to the marketing of products. For both purposes, the pharmaceutical companies sponsoring the research prefer, and often need, trials that meet high formal standards within medicine—often randomized, controlled trials, considered the “gold standard” of medical science. This requires access to large populations and often populations in multiple countries. Available populations are the result of a number of factors, and recently these have been pushing more trials to the developing world and Eastern Europe. Costs per patient are considerably lower in the developing world than in North America or Western Europe. Many people in the USA and Western Europe are unwilling to participate in trials, and many are ineligible because they are already being treated. Wealthier countries can be “treatment saturated,” whereas elsewhere there are many potential subjects who are “treatment naive.” Thus countries like India, for example, are well positioned to provide subjects; India’s Economic Times wrote in 2004: “The opportunities are huge, the multinationals are eager, and Indian companies are willing. We have the skills, we have the people ...” (Shah 2006: 17).
Most important for the argument of this chapter, though, is a point mentioned above: CROs have no interest in publishing the results under their own names. They simply produce data for their clients, and clients can use it to best advantage.