Bioequivalence and Bioavailability Forum

Hi Krish,

I agree with Ohlbe’s remark about the WMA’s Declaration of Helsinki (JAMA 2013) and the Medical Ethics Manual. See also the UNESCO’s Universal Declaration on Bioethics and Human Rights. I would emphasize part of the DoH’s § 26:

The potential subject must be informed of the right to refuse to participate in the study or to withdraw consent to participate at any time without reprisal.

Some CROs and their PIs are infamous for their “interpretation” of this section. They follow the widespread – but false! – belief that dropouts/withdrawals have a substantial impact on power.* Hence, they have an entire arsenal of leading questions “Don’t you think that strong headaches happen once in a while? Are you a man or a sissy?” or even threats “If you leave this study you will never be accepted for any other. Think about it!”…

---

• In most scenarios a dropout-rate of up to 15% reduces power by less than 5%.