The Contract Research Organization and the Commercialization of Scientific Research

Abstract

The early 1980s constituted a watershed in science, mainly concerning the extent and nature of globalization and commercialization of scientific research, and its impact upon the university. Considerable debate has arisen about the sources of this transition, but aside from a few lone voices, the scholarly literature has neglected the concurrent rise of the contract research organization (CRO) and its role int he commercialization of scientific research. The CRO warrants wider attention as a modern paradigm of privatized science in the biopharmaceutical sector. In discussing the CRO's technologies, the purposes they pursue, and the legal and policy initiatives that have fostered their rapid rise, we confront the wider implications of the modern regime of commercialized science for the future conduct of scientific research. We identify five areas of innovation: treatment of human subjects, control of disclosure, subjection of research tools to commercialization, redefinition of authorship, and re-engineering the goals of research.

Practicing research ethics: Private-sector physicians & pharmaceutical clinical trials

“…This contract research arrangement is so beneficial to private-sector physicians and the pharmaceutical industry that 13% of all practicing physicians are currently conducting at least one pharmaceutical study and 33% have conducted studies for the pharmaceutical industry at some point during their careers (HarrisInteractive, 2004). These changes have catalyzed a veritable industry to support both the pharmaceutical companies and the private-sector sites conducting clinical trials (Mirowski & Van Horn, 2005). For example, a primary goal of contract research organizations (CROs) is to aid pharmaceutical companies in selecting appropriate clinical sites that have large patient populations appropriate for specific clinical trials.…”

The increasing role of contract research organizations in the evolution of the biopharmaceutical industry

“…However, this growing reliance on external agents also raised concerns about the loss of control over the outsourced activities. Mirowski and Van Horn (2005) showed some interesting data on the growth of CROs in the 1990s, which they acquire from industry sources (Table 1). CROs' expansion is remarkable, with an increase of the market served by about 8 times.…”

In favour of a Millian proposal to reform biomedical research

“…That is, they primarily raise epistemic concerns. Since drugs that are approved can be marketed, moral and socio-economic consequences are immediate: an unsafe drug ought not to reach patients and companies ought not to reap profits 5 On CMOs in the context of commercialised research, see also Mirowski and Van Horn (2005). Source: De Francisco and Matlin (2006, 90) from them.…”