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Unformatted text preview: Globalizing clinical trials n American Ethnologist global testing of pharmaceuticals and provides the means through which pharmaceutical sponsors and their thirdparty CROs achieve recruitment successes. More human subjects
What drives the demand for larger pools of human subjects? First, it is the sheer number of trials being run. One market research company estimates that as of 2000, there were about 7,500 new clinical projects being designed for research and development worldwide. By 2001, that number had purportedly grown to 10,000 (Brescia 2002).6 Second, to satisfy U.S. regulatory demands, increasingly large numbers of patients must be included in clinical trials to prove products’ long-term safety, especially for drugs intended to be widely prescribed. Third, some therapeutic categories—such as hypertension—are being overwhelmed with new drugs. Competition to get these drugs approved and to bring them to market intensifies the search for subjects. Fourth, there is a ‘‘drug pipeline explosion’’—patent applications are flooding the U.S. Patent Office for new compounds that have yet to be clinically tested. Shifts in the very science of drug development also influence the decision to increase subject recruitment. As a vast amount of potential molecular therapeutics is generated, making right decisions regarding which molecules to test becomes more difficult. Consider Genasense, a technology made up of genetic snippets that pass through cells and block the expression of some harmful proteins. Wall Street investors learned that when the technology showed signs of failure in a late-phase clinical trial for patients with skin cancer, researchers recruited more research subjects in an attempt to find a statistically significant positive result. Finally, the available pool of human subjects in the United States is shrinking. The relatively affluent U.S. population is using too many drugs (Gorman 2004). ‘‘Treatment saturation’’ is making Americans increasingly unusable from a drug-testing standpoint, as our pharmaceuticalized bodies produce too many drug – drug interactions, providing less and less capacity to show drug effectiveness and making test results less statistically valid. Indeed, whatever an American is ready to provide as a human subject, owing to a belief in scientific progress, altruism, or therapeutic need, will never be enough to satisfy the current level of demand for human subjects in commercial science. And that Americans cannot satisfy the need is pushing the human-subjects research imperative to other shores. In this section, I examine historical aspects and operations of North American CROs, members of a specialized industry that began listing and selling securities on public exchanges in the early 1990s and that focuses on efficient and cost-effective human-subjects research and recruitment. The demand for human subjects in developing countries is related to the dynamics of industry-sponsored pharmaceutical drug testing in the United States. The roots of an expanding drug-testing regime are traceable to the post – World War II pharmaceutical boom in the United States, when a fee-for-service industry evolved in response to a demand for more safety testing in animals. Another point of origin for the expansion of humansubjects recruitment efforts dates back to the early 1970s, when the use of prisoner subjects in the United States was exposed and severely limited. According to one prominent executive, widely regarded as a founder of the CRO industry, pharmaceutical companies in the United States began internationalizing their human-subjects recruitment efforts as a response to regulatory limitations on prison research. (He directed the internationalization effort for one company in the mid-1970s.)7 The scale of U.S. prison research was impressive: An estimated 90 percent of drugs licensed prior to the 1970s were first tested on prison populations (Harkness 1996). When the ban on use of prisoners set in (for particular phases of testing), pharmaceutical companies lost almost an entire base of human volunteers and shifted a good deal of their research elsewhere, namely, to Europe (and countries with regulatory-friendly environments), but also to other areas with large subject pools whose access could be guaranteed because of centralized health systems and the closed nature of referral systems. By the early to mid-1980s, pharmaceutical companies were routinely outsourcing laboratory and clinical services, including preclinical bioassays, in which the activity of a chemical is assessed (mainly in animal models), and the monitoring of investigational sites and clinical data. By the early 1990s, drug development became a globalized endeavor, in part, under the aegis of the International Conference on Harmonisation, or ICH (in which the U.S. FDA played a key developmental role).8 The ICH created international standards for ensuring and assessing the safety and quality of testing procedures for experimental compounds, including Good Clinical Practice guidelines for investigators and the implementation of IRBs. Most importantly, it eased the acceptability and transference of clinical data from foreign investigational sites to the FDA for regulatory approval of new drugs.9 Today, CROs are highly competitive transnational businesses that run clinical trials for pharmaceutical, biotechnology, and medical device industries. They offer expertise in submissions of clinical trial data to regulatory bodies and in conducting market analyses of existing and prospective drugs. Their main source of revenue comes from conducting clinical trials in an efficient and costeffective manner, particularly the second and third phases 185 ...
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This note was uploaded on 10/10/2010 for the course ENG 000121 taught by Professor Mcgrand during the Spring '10 term at Cornell University (Engineering School).
- Spring '10