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

Omolara Aminat Fatiregun, Yetunde Kuyinu, Adewunmi Alabi, Anthonia Sowunmi, Okunuga Ndidi, Popoola O Abiodun, Temitope Olatunji-Agunbiade, Oyekan Ademola, Nnodimele Onuigbo Atulomah, Awotayo Olajumoke
Francis Okongo, Catherine Amuge, Alfred Jatho, Nixon Niyonzima, David Martin Ogwang, Jackson Orem
Johanna M. A. Klein, Isabel Runge, Ann-Katrin Pannen, Tariku Wakuma, Semaw Ferede Abera, Adamu Adissie, Susanne Unverzagt, Markus Schmitt, Tim Waterboer, Daniela Höfler, Christoph Thomssen, Eva Johanna Kantelhardt
Atul Budukh, Sharyu Mhamane, Sonali Bagal, Priyal Chakravarti, Ganesh Ogale, Radhika Sharma, Manisha Yadav, Sushama Saoba, Suvarna Gore, Pankaj Chaturvedi