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Reply to K. Jackson et al and W. Leppert

Journal Article


Abstract


  • We thank Jackson et al1 and Leppert2 for the opportunity to

    respond to their concerns regarding our article.3

    Our main point of contention is the belief, on the part of Jackson

    et al,1 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.4 This issue is particularly emphasized by the

    high placebo response rate (27%) demonstrated in our blinded, randomized

    controlled trial.

Authors


  •   Hardy, Janet (external author)
  •   Quinn, Stephen (external author)
  •   Fazekas, Belinda (external author)
  •   Eckermann, Simon
  •   Agar, Meera (external author)
  •   Spruyt, Odette (external author)
  •   Rowett, Debra (external author)
  •   Currow, David C. (external author)

Publication Date


  • 2013

Citation


  • 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.

Scopus Eid


  • 2-s2.0-84876086837

Ro Metadata Url


  • http://ro.uow.edu.au/ahsri/307

Number Of Pages


  • 1

Start Page


  • 1375

End Page


  • 1376

Volume


  • 31

Issue


  • 10

Abstract


  • We thank Jackson et al1 and Leppert2 for the opportunity to

    respond to their concerns regarding our article.3

    Our main point of contention is the belief, on the part of Jackson

    et al,1 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.4 This issue is particularly emphasized by the

    high placebo response rate (27%) demonstrated in our blinded, randomized

    controlled trial.

Authors


  •   Hardy, Janet (external author)
  •   Quinn, Stephen (external author)
  •   Fazekas, Belinda (external author)
  •   Eckermann, Simon
  •   Agar, Meera (external author)
  •   Spruyt, Odette (external author)
  •   Rowett, Debra (external author)
  •   Currow, David C. (external author)

Publication Date


  • 2013

Citation


  • 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.

Scopus Eid


  • 2-s2.0-84876086837

Ro Metadata Url


  • http://ro.uow.edu.au/ahsri/307

Number Of Pages


  • 1

Start Page


  • 1375

End Page


  • 1376

Volume


  • 31

Issue


  • 10