Are phase 1 trials therapeutic? Risk, ethics, and division of labor
Bioethics (forthcoming)
| Abstract | Despite their crucial role in the translation of pre-clinical research into new clinical applications, phase 1 trials involving patients continue to prompt ethical debate. At the heart of the controversy is the question of whether risks of administering experimental drugs are therapeutically justified. We suggest that prior attempts to address this question have been muddled, in part because it cannot be answered adequately without first attending to the way labor is divided in managing risk in clinical trials. In what follows, we approach the question of therapeutic justification for phase 1 trials from the viewpoint of five different stakeholders: the drug regulatory authority, the IRB, the clinical investigator, the referring physician, and the patient. Our analysis shows that the question of therapeutic justification actually raises multiple questions corresponding to the roles and responsibilities of the different stakeholders involved. By attending to these contextual differences, we provide more coherent guidance for the ethical negotiation of risk in phase 1 trials involving patients. We close by discussing the implications of our argument for various perennial controversies in phase 1 trial practice | |||||||||
| Keywords | clinical research ethics phase 1 trials risk therapy | |||||||||
| Categories | ||||||||||
| Options |
|
|||||||||
Download options| PhilPapers Archive |
Upload a copy of this paper Check publisher's policy on self-archival Papers currently archived: 5,865 |
| External links |
 |
| Through your library | Configure |
Similar books and articlesAudrey R. Chapman & Courtney C. Scala (2012). Evaluating the First-in-Human Clinical Trial of a Human Embryonic Stem Cell-Based Therapy. Kennedy Institute of Ethics Journal 22 (3):243-261.
Frederic Gilbert, Alexander R. Harris & Robert M. I. Kapsa (2012). Efficacy Testing as a Primary Purpose of Phase 1 Clinical Trials: Is It Applicable to First-in-Human Bionics and Optogenetics Trials? AJOB Neuroscience 3 (2):20-22.
Thomas C. Jones (2005). A Call to Restructure the Drug Development Process: Government Over-Regulation and Non-Innovative Late Stage (Phase III) Clinical Trials Are Major Obstacles to Advances in Health Care. Science and Engineering Ethics 11 (4):575-587.
Maurie Markman (2004). The Research Misconception. International Journal of Applied Philosophy 18 (2):241-252.
Gary E. Marchant & Rachel A. Lindor (2012). Prudent Precaution in Clinical Trials of Nanomedicines. Journal of Law, Medicine and Ethics 40 (4):831-840.
Simon Woods & Pauline Mccormack (2013). Disputing the Ethics of Research: The Challenge From Bioethics and Patient Activism to the Interpretation of the Declaration of Helsinki in Clinical Trials. Bioethics 27 (5):243-250.
James A. Anderson Jonathan Kimmelman (2010). Extending Clinical Equipoise to Phase 1 Trials Involving Patients: Unresolved Problems. Kennedy Institute of Ethics Journal 20 (1):pp. 75-98.
James A. Anderson & Jonathan Kimmelman (2010). Extending Clinical Equipoise to Phase 1 Trials Involving Patients: Unresolved Problems. Kennedy Institute of Ethics Journal 20 (1):75-98.
Jonathan Kimmelman (2007). Clinical Trials and Scid Row: The Ethics of Phase 1 Trials in the Developing World. Developing World Bioethics 7 (3):128–135.
Erwin J. O. Kompanje (2007). No Time to Be Lost! Science and Engineering Ethics 13 (3).
Jonathan Kimmelman (2004). Valuing Risk: The Ethical Review of Clinical Trial Safety. Kennedy Institute of Ethics Journal 14 (4):369-393.
Danielle Laudy (forthcoming). End of Life Pediatric Research: What About the Ethics? Journal of Academic Ethics.
Analytics
Monthly downloads |
Added to index2012-06-11Total downloads10 ( #107,683 of 556,774 )Recent downloads (6 months)1 ( #64,847 of 556,774 )How can I increase my downloads? |
My notes
Discussion
