Prasad警告,基因疗法或神经药物领域的类Theranos欺诈可借助中途更换终点、无对照联合用药、历史对照等薄弱试验设计长期存活。
如果她做的是基因疗法或神经系统疾病药物,并做出同样虚假且有害的宣称,她可能至今仍拥有一家数十亿美元的公司。虚假承诺需要数年才会被发现——如果能被发现的话。她只需在试验中途更改终点,采用联合用药且不设对照组,或者声称根本无法随机化而使用历史对照。原文 (en)
If she made a gene therapy or drug for neurologic disorder, and made similarly false and harmful claims, she may yet still have a multi-billion dollar company. It takes years— if at all— for the false promise to be detected. She could just change her endpoints mid-trial, give her drug in combination and without a control arm, or claim that you can’t randomize at all and use historical controls.