Reply to K. Jackson et al and W. Leppert

Authors

Janet Hardy, University of Queensland
Stephen Quinn, Flinders University
Belinda Fazekas, Flinders University
Simon Eckermann, University of WollongongFollow
Meera Agar, Braeside Hospital
Odette Spruyt, Peter MacCallum Cancer Centre
Debra Rowett, Flinders University
David Currow, Flinders University, Cancer Institute New South Wales

RIS ID

77977

Publication Details

J. Hardy, S. Quinn, B. Fazekas, S. Eckermann, M. R. Agar, O. Spruyt, D. Rowett & D. Currow, "Reply to K. Jackson et al and W. Leppert", Journal of Clinical Oncology 31 10 (2013) 1375-1376.

Abstract

We thank Jackson et al and Leppert for the opportunity to respond to their concerns regarding our article.

Our main point of contention is the belief, on the part of Jackson et al, that unblinded, nonrandomized, prospective audits can give a true indication of the efficacy or toxicity of a drug. Open-label studies do not meet the specific scientific definition of control. The gross underestimation and overestimation of effects in uncontrolled trials, especially studies that involve small numbers of participants, have been well documented. This issue is particularly emphasized by the high placebo response rate (27%) demonstrated in our blinded, randomized controlled trial.