In this article, we model the relationship between a health authority and a pharmaceutical firm when the real efficacy of the drug manufactured by the firm is uncertain. The ex-ante information on the efficacy of the new drug is pro¬vided by the outcomes of a clinical trial. We focus on two...

There has been tremendous progress over the last decade in the development of health products for neglected diseases. These include drugs, vaccines, and diagnostics for malaria and tuberculosis, which kill millions of people annually, plus other diseases like chagas and dengue fever, which may...

Purpose – The aging of the population, high prevalence of chronic diseases, and increased need for evidence‐based practice are factors that have boosted a high demand for clinical trials in the United States. In recent years, an increasing number of clinical trials have shifted from academic...

Purpose – The purpose of this paper is to establish historic regulatory conditions and priority national characteristics eliciting outstanding best practices in clinical trial regulatory systems, towards global health objectives through targeted economic development....

Purpose – If the use of information technology (IT) supporting clinical trial projects offers opportunities to optimize the underlying information management process, the intricacy of the identification and evaluation of relevant IT options is generally seen as a complex task in healthcare....

This paper analyzes the debate over the international dissemination of data exclusivity as a form of protection for clinical trial data. This is a critical demand for pharmaceutical companies seeking larger market shares and longer periods of monopoly in order to recover investments in research...