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
David Bourget (Western Ontario)
David Chalmers (ANU, NYU)
Rafael De Clercq
Ezio Di Nucci
Jack Alan Reynolds
Learn more about PhilPapers
Science and Engineering Ethics 11 (4):575-587 (2005)
The history of drug/vaccine development has included major advances guided primarily by risk/benefit analyses concerning the innovative agent, not by evidence-based clinical trials (Phase I–IV). Because the approval for new drugs is hindered under the present process, the system requires restructuring. The Phase I/II study period should be more flexible, using the “environment of knowledge” about the new agent, plus risk/benefit assessments. Phase III, as presently constructed, does not add new adverse events data, it provides a narrower profile of drug efficacy than properly done Phase II studies, and placebo-controlled trials continue to raise unresolved ethical and social issues. Phase III studies should be abandoned for most drugs, and substituted with properly powered Phase II doseranging studies plus careful post-marketing surveillance. Phase III should be a penalty for poor drug development, not a regulatory requirement.
|Keywords||Drug regulation Phase I–III clinical trials Post-marketing surveillance Drug Discovery/Development|
|Categories||categorize this paper)|
Setup an account with your affiliations in order to access resources via your University's proxy server
Configure custom proxy (use this if your affiliation does not provide a proxy)
|Through your library|
References found in this work BETA
Louis Lasagna (1988). Congress, the FDA, and New Drug Development: Before and After 1962. Perspectives in Biology and Medicine 32 (3):322-343.
Citations of this work BETA
No citations found.
Similar books and articles
Monika Anna Sawicka & Ron A. Bouchard, The Mud and the Blood and the Beer: Canada's New Progressive Licensing Framework for Drug Approval.
Abraham Fuks, Charles Weijer, Benjamin Freedman, Stanley Shapiro, Myriam Skrutkowska & Amina Riaz, A Study in Contrasts: Eligibility Criteria in a Twenty-Year Sample of NSABP and POG Clinical Trials.
John Davis, William Giakas, Jie Que, Pavan Passad & Stefan Leucht (2011). Should We Treat Depression with Drugs or Psychological Interventions? A Reply to Ioannidis. Philosophy, Ethics, and Humanities in Medicine 6 (1):8-.
Erwin J. O. Kompanje (2007). No Time to Be Lost! Science and Engineering Ethics 13 (3):371-381.
Jacek Spławiński, Jerzy Kuźniar, Krzysztof Filipiak & Waldemar Zieliński (2006). Evaluation of Drug Toxicity in Clinical Trials. Science and Engineering Ethics 12 (1):139-145.
R. G. Seigneuric, J.-L. Chassé, P. Auger & A. Bardou (2005). Simulated Interactions Between a Class III Antiarrhythmic Drug and a Figure 8 Reentry. Acta Biotheoretica 53 (4):265-275.
Udo Schüklenk & Christopher Lowry (2009). Terminal Illness and Access to Phase 1 Experimental Agents, Surgeries and Devices: Reviewing the Ethical Arguments. British Medical Bulletin 89 (1):7-22.
Laurence J. Hirsch (2002). Conflicts of Interest in Drug Development: The Practices of Merck & Co., Inc. Science and Engineering Ethics 8 (3):429-442.
Added to index2009-01-28
Total downloads23 ( #164,288 of 1,796,218 )
Recent downloads (6 months)9 ( #85,248 of 1,796,218 )
How can I increase my downloads?