Alessandria, Italy – 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 or not to develop a clinical trial in a given country?
Clinical research is a specific phase of the pharmaceutical industry’s production process in which companies test candidate drugs on patients in order to collect clinical evidence about safety and effectiveness. This information is essential in order to obtain manufacture 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 interest. On 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). In order to abide by this moral duty, a protection system was developed that is based on two legal institutions: Informed Consent and the Institutional Review Board (IRB) or Ethics Committee.
Looking at Europe and considering a protection system that is shaped around IRBs, the paper, “Economic Efficiency of Countries’ Clinical Review Processes and Competitiveness on the Market of Human Experimentation,” published in Value in Health, is an empirical work that tries to answer the aforementioned questions.
This work shows how a protection system that can minimize the time necessary to start a trial can positively affect pharmaceutical companies’ choice to start innovative medical treatments in a given country. The results of the study suggest that a national protection system should be shaped around a competitive approach, with each IRB pushed to compete on the basis of time factors to attract pharmaceutical companies. Features of this ideal system might be related to a high number of competitive IRBs with an appropriate mechanism of economic incentive.
Dr. Roberto Ippoliti, PhD, from the University of Eastern Piedmont “Amedeo Avogadro,” and lead author on the study states, “This paper has shown one potential way in which a policy maker could improve national competitiveness on the global market of clinical research, supporting the idea that, if an IRB can minimize the required time to authorize a trial, the pharmaceutical industry’s investment (in the testing phase) will increase.”
Value in Health (ISSN 1098-3015) publishes papers, concepts, and ideas that advance the field of pharmacoeconomics and outcomes research as well as policy papers to help health care leaders make evidence-based decisions. The journal is published bi-monthly and has over 8,000 subscribers (clinicians, decision makers, and researchers worldwide).
International Society for Pharmacoeconomics and Outcomes Research (ISPOR) is a nonprofit, international, educational and scientific organization that strives to increase the efficiency, effectiveness, and fairness of health care resource use to improve health.
For more information: www.ispor.org