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 (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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DOI 10.1007/s11948-005-0027-y
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