Efficient trial designs to reduce placebo requirements

Biological Psychiatry

Volumn 47, Issue 8, 2000, Pages 724-726

  Krishnan, K R R ^a  

^a DUKE UNIVERSITY MEDICAL CENTER   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

ENOXAPARIN; FLUOXETINE; PLACEBO;

CLINICAL TRIAL; HUMAN; MENTAL DISEASE; METHODOLOGY; PRIORITY JOURNAL; REM SLEEP; SHORT SURVEY; THROMBOEMBOLISM;

EID: 0034655998     PISSN: 00063223     EISSN: None     Source Type: Journal    
DOI: 10.1016/S0006-3223(99)00320-0     Document Type: Editorial

References (13)

1. L. Bienenfeld W. Frishman S.P. Glasser The placebo effect in cardiovascular disease Am Heart J 132 1996 1207 1221
2. O. Bjerkeset S. Larsen O. Reiertsen Evaluation of enoxaparin given before and after operation to prevent venous thromboembolism during digestive surgery Play the winner designed study World J Surg 21 1997 584 589
3. O. Chassany M. Duracinsky Ethics and clinical trials Fundam Clin Pharmacol 13 1999 437 444
4. S.J. Edwards R.J. Lilford D.A. Braunholtz J.C. Jackson J. Hewison J. Thornton Ethical issues in the design and conduct of randomized controlled trials Health Technol Assess 2 1998 1 132
5. J. Hogel H. Walach W. Gaus Change-to-Open-Label Design. Proposal and discussion of a new design for clinical parallel-group double masked trials Arzneimittelforschung 44 1994 97 99
6. E. Perucca T. Tomson Monotherapy trials with the new antiepileptic drugs Study designs, practical relevance and ethical implications Epilepsy Res 33 1999 247 262
7. F.M. Quitkin Placebos, drug effects, and study design A clinician’s guide Am J Psychiatry 156 1999 829 836
8. O. Reiertsen S. Larsen J.H. Solhaug Development of play-the-winner design Weighting and accumulation of information Scand J Clin Lab Invest 58 1998 241 249
9. W.F. Rosenberger F. Hu Bootstrap methods for adaptive designs Stat Med 18 1999 1757 1767
10. R.N. Tamura D.E. Farris J.S. Andersen J.H. Heilgigenstein A case study of an adaptive clinical trial in the treatment of outpatients with depressive disorder J Am Stat Assoc 89 1994 768 776
11. M.A. Weber The ethics of using placebo in hypertension clinical trials J Hypertens 17 1999 5 8
12. Weijer C (1999): Placebo-controlled trials in schizophrenia: Are they ethical? Are they necessary? Schizophr Res 35:211–218; discussion 227–236.
13. Yao Q, Wei LJ (1996): Play the winner for phase II/III clinical trials. Stat Med 15:2413–2423; discussion 2455–2458.