title: Drug development: how academia, industry and authorities interact.
abstract: Unfortunately, abundant examples could be given of pitfalls in the current drug development paradigm-including in the design, conduct and evaluation of phase III clinical trials. This article discusses issues of particular relevance to clinical trials in nephrology, including the inappropriate use of placebo, publication of reports that emphasize potential treatment benefits over adverse reactions, the sometimes dubious impartiality of independent guidelines, and inadequate recruitment of elderly patients. This Perspectives article aims to highlight and summarize the flaws in the current drug development process, while suggesting a way forward that equally satisfies the requirements of academia, patients and the pharmaceutical industry. We suggest improvements to the drug development process and related legislation that intend to balance public needs with commercial aims and ensure effective drug evaluation by regulatory authorities.
authors.affiliation: IRCCS (Istituto di Ricovero e Cura a Carattere Scientifico) Istituto di Ricerche Farmacologiche "Mario Negri", via Giuseppe La Masa 19, 20156 Milan, Italy.
authors.forename: Silvio
authors.initials: S
authors.lastname: Garattini
authors.affiliation: IRCCS (Istituto di Ricovero e Cura a Carattere Scientifico) Istituto di Ricerche Farmacologiche "Mario Negri", via Giuseppe La Masa 19, 20156 Milan, Italy.
authors.forename: Norberto
authors.initials: N
authors.lastname: Perico
mesh_terms: D002986:Clinical Trials as Topic; D017277:Drug Approval; D055808:Drug Discovery; D004345:Drug Industry; D004335:Drug and Narcotic Control; D005060:Europe; D006801:Humans; D007564:Japan; D009398:Nephrology; D015990:Placebo Effect; D014481:United States; D014486:United States Food and Drug Administration; D014495:Universities
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