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

Ralph Victor Yap, Deanne Lou Marquez, Frances Marion De La Serna
Neetha Mary Kurian, Jeffrey Mathew Boby, Somannair Suneesh, Sumit Datta, Aju Mathew
Noon I Eltoum, Nicole E Caston, Lily Gutnik, Mahmoud A Alfardous Alazm, Feras O Mohamed, Lama M Abdalkarem, Saad A S Ali, Abrar Z Badawi, Nicole L Henderson, Andres Azuero, Gabrielle Rocque
Julia Downing, Nixon Niyonzima, Eddie Mwebesa, Lisa Christine Irumba, Judith Asasira, Bernadette Basemera, Diana Basirika, Alfred Jatho, Immaculate Mbarusha, Harriet Nalubega, Dorothy Olet Adong, Deirdre Ryan, Danait Tesfai, Cynthia Kabagambe, Joyce Zalwango, Catherine Amuge, Cissy Nassolo, Edward Kakungulu, Jackson Orem, Mark Mwesiga
Sattam A Halaseh, Amro Al-Karadsheh, Deborah Mukherji, Abdelrahman Alhjahaja, Ala’a Farkouh, Akram Al-Ibraheem, Ibrahim Abu Gheida, Sultan Al-Khateeb, Humaid Al-Shamsi, Mohammed Shahait
Natalia Martínez Arias, Ángel Alfonso Aguirre Durán, Mayra Yiseth Ramírez Lozano, Celia Díez de los Ríos de la Serna, Mar ía Fernanda Olarte-Sierra, Julia Challinor, Yuli Vanessa Girón Arbelaez, Magali Yolima Mera Díaz, Luz Damaris Rojas Rodríguez