ecancermedicalscience

Review

Phase 0 clinical trials: towards a more complete ethics critique

27 Mar 2012
TP Hill

In efforts to modernise the entire drug-development process, making it more efficient, less costly, and ultimately of real benefit to patients, The Federal Drug Administration (FDA) authorised the use of exploratory IND or early Phase I (Phase 0) studies. Quite different in structure from Phase I, II, and III studies, the Phase 0 construct understandably poses a set of ethical problems not seen in the other research phases and so far not adequately addressed by ethicists. In an effort to deal with this deficiency, this paper proposes an ethics critique, based not on the usual concept of benefit, but on the means–end relation, and placed within an ethic of science derived from the practice of science.

Related Articles

Nuradh Joseph, Vimukthini Peiris, Vodathi Bamunuarachchi, Prasad Abeysinghe, Nadarajah Jeyakumaran, Devinda Jayathilake, Kanthi Perera, Rohini Fernandopulle, Sanjeeva Gunasekera
Susan Msadabwe, Peng Yun Ng, Richard Sullivan, Kennedy Lishimpi, John Kachimba, Justor Banda, Jane Mumba, Abidan Chansa, Mutuna Chiwele, Kasonde Bowa, Kaseya Chiyenu, Linda Malulu-Chiwele, Julie Torode, Grant Lewison, Andrew Leather, Ajay Aggarwal, Kathleen Schmeler, Groesbeck Parham, Kabisa Mwala, Paul Kamfwa
Jessica O Esangbedo, Rachael O Oduyemi, Damilare Aduroja, Yetunde O Tola, Olajumoke Dele-Alonge, Emmanuel O Adesuyi, Michael O Ajiboye, Oluwadamilare Akingbade
Francisca Quintanilla, Álvaro Torres, Monserrat Villar, Catalina Muñoz, José Lizama, Bárbara Mena
Chase Peng Yun Ng, Moira Hegyi, Grant Lewison, Tania Pastrana, Eve Namisango, James Cleary, Barbara Hasties, Eric Kabisa, Helena Musau, Kathryn Spangenberg, Paola Ruiz, Zipporah Ali, Mertixell Mallafre-Larrosa, Alfredo Polo, Julie Torode, Ajay Aggarwal, Richard Sullivan, Mevhibe Hocaoglu