| 来源类型 | Working Paper |
| 规范类型 | 报告 |
| DOI | 10.3386/w21499 |
| 来源ID | Working Paper 21499 |
| Is the FDA Too Conservative or Too Aggressive?: A Bayesian Decision Analysis of Clinical Trial Design | |
| Vahid Montazerhodjat; Andrew W. Lo | |
| 发表日期 | 2015-08-31 |
| 出版年 | 2015 |
| 语种 | 英语 |
| 摘要 | Implicit in the drug-approval process is a trade-off between Type I and Type II error. We explore the application of Bayesian decision analysis (BDA) to minimize the expected cost of drug approval, where relative costs are calibrated using U.S. Burden of Disease Study 2010 data. The results for conventional fixed-sample randomized clinical-trial designs suggest that for terminal illnesses with no existing therapies such as pancreatic cancer, the standard threshold of 2.5% is substantially more conservative than the BDA-optimal threshold of 27.9%. However, for relatively less deadly conditions such as prostate cancer, 2.5% is more risk-tolerant or aggressive than the BDA-optimal threshold of 1.2%. We compute BDA-optimal sizes for 25 of the most lethal diseases and show how a BDA-informed approval process can incorporate all stakeholders’ views in a systematic, transparent, internally consistent, and repeatable manner. |
| 主题 | Econometrics ; Estimation Methods ; Health, Education, and Welfare ; Health |
| URL | https://www.nber.org/papers/w21499 |
| 来源智库 | National Bureau of Economic Research (United States) |
| 引用统计 | |
| 资源类型 | 智库出版物 |
| 条目标识符 | http://119.78.100.153/handle/2XGU8XDN/579174 |
| 推荐引用方式 GB/T 7714 | Vahid Montazerhodjat,Andrew W. Lo. Is the FDA Too Conservative or Too Aggressive?: A Bayesian Decision Analysis of Clinical Trial Design. 2015. |
| 条目包含的文件 | 条目无相关文件。 | |||||
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