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
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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|
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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.
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