Grant: Project Grant

The nature and scope of genomic initiatives in the cancer domain has expanded dramatically in recent years. A shift from the initial focus on diagnosis to the development of targeted drugs and novel immunotherapies has given renewed meaning to notions such as personalized or precision medicine. The exploration, validation and testing of these therapies in clinical trials, their approval by regulators, and the necessary articulation of novel approaches with established clinical practices raise, however, a number of major organizational, regulatory, and sociotechnical issues, which in turn call for innovative solutions. These often-controversial solutions include the redesign of clinical trials in connection with the deployment of novel analytical platforms, new organizational infrastructures, and revised conceptual perspectives. The purpose of our project is to provide an analytical understanding of this intricate process, based on a detailed empirical investigation of the aforementioned initiatives. In particular, we seek to analyze how fundamental changes in the social, organizational, and conceptual configuration of clinical trials, the gold standard of modern medicine, are expressed in new collective modes of practice and interaction. A number of observers have expressed concerns about the premature adoption of genomic techniques or the dire consequences of delaying it. Our analysis of clinical research will provide the grounds for exploring these issues and thus offer both oncologists and healthcare analysts implements with which to better frame genomic medicine initiatives.