PMID: 16501655Feb 28, 2006Paper

Evaluation of drug toxicity in clinical trials

Science and Engineering Ethics
J SplawinskiW Zielinski

Abstract

An increasing number of drugs removed from the market because of unacceptable toxicity raises concerns regarding pre-approval testing of drug safety. In the present paper it is postulated that the non-inferiority type of trial should be abandoned in favor of the superiority trial with active controls and less stringent (p<0.1, both for efficacy and toxicity) statistics. This approach will increase sensitivity of detection of drug-induced adverse effects at the expense of increasing false positive results regarding the difference in efficacy between the tested and reference drug. Such a move will increase the protection of future patients. In addition, the proposed design is far more acceptable from the clinical (e.g. no need to specify the statistically expected "unimportant" number of deaths) and ethical points of view, as well as being favored by the strong incentive of involved parties. In the second part of this paper arguments are presented in favor of the hypothesis that placebo (still used in some superiority trials) does not induce adverse effects. The assertion that placebo may induce adverse effects is probably biased by the nature of the clinical experiment. Such a conclusion is supported by studies indicating that p...Continue Reading

References

Nov 23, 2000·The New England Journal of Medicine·C BombardierUNKNOWN VIGOR Study Group
May 24, 2001·The New England Journal of Medicine·A Hróbjartsson, P C Gøtzsche
Jan 5, 2002·The American Journal of Psychiatry·Andrew F LeuchterMichelle Abrams
Feb 28, 2004·Science and Engineering Ethics·Jacek Spławiński, Jerzy Kuźniar
Mar 25, 2005·The New England Journal of Medicine·Susan Okie
Apr 1, 2005·The New England Journal of Medicine·Susan Okie
Apr 1, 2005·The New England Journal of Medicine·Rebecca S Eisenberg
Jun 11, 2005·The New England Journal of Medicine·Gert Van AsschePaul Rutgeerts

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Citations

Jun 16, 2012·Journal of Controlled Release : Official Journal of the Controlled Release Society·Sok Bee LimHayat Önyüksel
Jun 23, 2021·ACS Applied Materials & Interfaces·Colleen R McCollumAnushree Chatterjee

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