The conduct of clinical trials: a Food and Drug Agency perspective
| Autor: | Wolf Sapirstein |
|---|---|
| Rok vydání: | 2000 |
| Předmět: |
medicine.medical_specialty
Device Approval media_common.quotation_subject Biomedical Engineering Biophysics Alternative medicine Bioengineering Conformity Scientific evidence Biomaterials Agency (sociology) Medicine Humans health care economics and organizations media_common Protocol (science) Clinical Trials as Topic business.industry United States Food and Drug Administration Clinical study design General Medicine Public relations United States Clinical trial Equipment and Supplies business |
| Zdroj: | ASAIO journal (American Society for Artificial Internal Organs : 1992). 46(1) |
| ISSN: | 1058-2916 |
| Popis: | The conduct of a clinical trial required by FDA regulations should be executed in conformity with a protocol developed as a cooperative endeavor involving the Agency, the sponsor requiring device approval for marketing, and the investigators. This is the process most likely to assure a scientifically satisfactory study design that will address the primary concerns of all the parties. More importantly, timely access to safe and effective technologic advances will be made available to the health provider community based on the best scientific evidence. |
| Databáze: | OpenAIRE |
| Externí odkaz: |
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