The Relation of Smallpox Morbidity to Vaccination Laws

Woodward, Samuel B.; Feemster, Roy F.

doi:10.1056/nejm193302092080607

Cited by 13 publications

(2 citation statements)

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“…5 The advantages of vaccination with this material were shown in observational studies based on varied state requirements for the vaccine use in the United States in the 1920s. 6 This led to universal requirement for use of the vaccine, and to eradication of smallpox from the world in 1977. This material has been frozen for decades and it has been the basis of Phase II trials using a surrogate end-point, in an attempt to use more diluted material in the vaccination.…”

Section: A Brief History Of Drug/vaccine Researchmentioning

confidence: 99%

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

Jones¹

2005

SCI ENG ETHICS

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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.

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Section: A Brief History Of Drug/vaccine Researchmentioning

confidence: 99%