  While within a clinical study there may be multiple doses and endpoints,
across different studies each study will result in either an approval or a lack
of approval of the drug compound studied. The term False Approval Rate (FAR) is
the term this paper utilizes to represent the proportion of drug compounds that
lack efficacy incorrectly approved by regulators. (In the U.S., compounds that
have efficacy and are approved are not involved in the FAR consideration,
according to our reading of the relevant U.S. Congressional statute).
  While Tukey's (1953) Error Rate Familywise (ERFw) is meant to be applied
within a clinical study, Tukey's (1953) Error Rate per Family (ERpF), defined
along-side ERFw, is meant to be applied across studies. We show that
controlling Error Rate Familywise (ERFw) within a clinical study at 5% in turn
controls Error Rate per Family (ERpF) across studies at 5-per-100, regardless
of whether the studies are correlated or not. Further, we show that ongoing
regulatory practice, the additive multiplicity adjustment method of controlling
ERpF, is controlling False Approval Rate (FAR) exactly (not conservatively) at
5-per-100 (even for Platform trials).
  In contrast, if a regulatory agency chooses to control the False Discovery
Rate (FDR) across studies at 5% instead, then this change in policy from ERpF
control to FDR control will result in incorrectly approving drug compounds that
lack efficacy at a rate higher than 5-per-100, because in essence it gives the
industry additional rewards for successfully developing compounds that have
efficacy and are approved. Seems to us the discussion of such a change in
policy would be at a level higher than merely statistical, needing
harmonizsation/harmonization (In the U.S., policy is set by the Congress).
