But it is ethically questionable to test a drug for “non-inferiority,” because patients are exposed to potential risks while contributing, in the best case, to the development of a drug that is no better than those already available. Patients’ informed consent usually does not provide a clear description of a non-inferiority trial, and the lack of added value indicates that in many cases the development of a new drug is driven by commercial aims rather than patients’ needs.
新药试验通常与安慰剂或市场上的非首选药物对照，目的是显示其疗效不逊于任何已上市的药品。但试验某种新药的“非劣效性”在道德上是值得拷问的，因为即便在最好的情况下，病人在为一种并不比已有药物疗效更好的药物的研制做出贡献的同时，也被暴露于潜在的风险中。病人的知情同意通常不能为非劣效性试验提供一个清晰的描述。而且缺乏附加值意味着在很多情况下新药的研发是被商业目的而非病人需求所驱动。