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Drug development: how academia, industry and authorities interact

Nature Reviews Nephrology volume 10, pages 602–610 (2014)Cite this article

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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.

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Acknowledgements

The authors are grateful to Vanna Pistotti for assistance with the bibliography.

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  1. IRCCS (Istituto di Ricovero e Cura a Carattere Scientifico) Istituto di Ricerche Farmacologiche “Mario Negri”, via Giuseppe La Masa 19, Milan, 20156, Italy

    Silvio Garattini & Norberto Perico

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Garattini, S., Perico, N. Drug development: how academia, industry and authorities interact. Nat Rev Nephrol 10, 602–610 (2014). https://doi.org/10.1038/nrneph.2014.133

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