title: Economic efficiency of countries' clinical review processes and competitiveness on the market of human experimentation.
abstract: Clinical research is a specific phase of pharmaceutical industry's production process in which companies test candidate drugs on patients to collect clinical evidence about safety and effectiveness. Information is essential to obtain manufacturing authorization from the national drug agency and, in this way, make profits on the market. Considering this activity, however, the public stakeholder has to face a conflict of interests. On the one side, there is society's necessity to make advances in medicine and, of course, to promote pharmaceutical companies' investments in this specific phase (new generation). On the other side, there is the duty to protect patients involved in these experimental treatments (old generation). To abide by this moral duty, a protection system was developed through the years, based on two legal institutions: informed consent and institutional review board. How should an efficient protection system that would take human experimentation into account be shaped? Would it be possible for the national protection system of patients' rights to affect the choice of whether to develop a clinical trial in a given country or not? Looking at Europe and considering a protection system that is shaped around institutional review boards, this article is an empirical work that tries to give answers to these open questions. It shows how a protection system that can minimize the time necessary to start a trial can positively affect pharmaceutical clinical research, that is, the choice of pharmaceutical companies to start innovative medical treatments in a given country.
authors: POLIS Institute, University of Eastern Piedmont, Alessandria, Italy. oberto.ippoliti@unipmn.it
authors: Roberto
authors: R
authors: Ippoliti
mesh_terms: D035843:Biomedical Research / Q000191:economics* / Q000941:ethics / Q000379:methods; D002755:Choice Behavior; D002986:Clinical Trials as Topic / Q000191:economics* / Q000941:ethics / Q000379:methods; D016265:Conflict of Interest; D015195:Drug Design; D004345:Drug Industry / Q000191:economics* / Q000941:ethics; D017598:Efficiency, Organizational / Q000191:economics / Q000941:ethics; D028744:Ethics Committees, Research; D005060:Europe; D006805:Human Experimentation; D006801:Humans; D007258:Informed Consent; D028701:Patient Rights; D013997:Time Factors