title: 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.
abstract: 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 dose-ranging studies plus careful post-marketing surveillance. Phase III should be a penalty for poor drug development, not a regulatory requirement. To accomplish efficient drug development, greater cooperation between pharmaceutical companies and governments in developing clinical trials is needed rather than over-regulation. These changes will synchronize the drug development and regulatory process with the current rapid drug discovery process, reduce drug development time and cost, and improve patient care.
authors.affiliation: Clinical Research Consultants, Ob. Rheinweg 71, 4058 Basle, Switzerland. 100767.711@compuserve.com
authors.forename: Thomas C
authors.initials: TC
authors.lastname: Jones
mesh_terms: D000818:Animals; D017326:Clinical Trials, Phase III as Topic / Q000331:legislation & jurisprudence*; D017277:Drug Approval / Q000379:methods*; D004345:Drug Industry / Q000458:organization & administration*; D006801:Humans