Designs can increase efficiency in psychiatric drug development: A case study

Innovations in Clinical Neuroscience

Volumn 8, Issue 7, 2011, Pages 26-34

  Shen, Joan ^a   Preskorn, Sheldon ^b   Dragalin, Vladimir ^c   Slomkowski, Mary ^a   Krishna Padmanabhan, S ^a   Fardipour, Parvin ^a   Sharma, Amarnath ^a   Krams, Michael ^d  

^a PFIZER INC   (United States)

^b UNIVERSITY OF KANSAS SCHOOL OF MEDICINE WICHITA   (United States)

^c ICON PLC   (United Kingdom)

^d JANSSEN RESEARCH AND DEVELOPMENT   (United States)

Author keywords

Bayesian statistics; Clinical trial design; Neuropsychopharmacology; Response adaptive dose allocation; Schizophrenia

Indexed keywords

PLACEBO; RISPERIDONE; SEROTONIN 2C AGONIST;

ADULT; ALANINE AMINOTRANSFERASE BLOOD LEVEL; ARTICLE; ASPARTATE AMINOTRANSFERASE BLOOD LEVEL; BAYESIAN LEARNING; CONTROLLED STUDY; DISEASE EXACERBATION; DIZZINESS; DOSE RESPONSE; DOUBLE BLIND PROCEDURE; DRUG DESIGN; DRUG DOSE COMPARISON; DRUG EFFICACY; DRUG RESEARCH; DRUG SAFETY; DRUG WITHDRAWAL; DYSPEPSIA; FEMALE; HUMAN; MAJOR CLINICAL STUDY; MALE; MATHEMATICAL ANALYSIS; MATHEMATICAL MODEL; METHODOLOGY; MULTICENTER STUDY; OUTCOME ASSESSMENT; PROBABILITY; RANDOMIZED CONTROLLED TRIAL; SCHIZOPHRENIA; SIDE EFFECT; SIMULATION;

EID: 80052048316     PISSN: 21588333     EISSN: 21588341     Source Type: Journal    
DOI: None     Document Type: Article

References (11)

1. Di Giovanni G, Di Matteo V, Di Mascio M, Esposito E. Preferential modulation of mesolimbic vs. nigrostriatal dopaminergic function by serotonin (2C/2B) receptor agonists: a combined in-vivo electrophysiological and microdialysis study. Synapse.2000;35:53-61.
2. Di Matteo V, Di Giovanni G, Di Mascio M, Esposito E. SB 242084, a selective serotonin-2C receptor antagonist, increases dopaminergic transmission in the mesolimbic system. Neuropharmacology.1999;38:1195-1205.
3. Gallo P, Chuang-Stein C, Dragalin V, et al. Adaptive designs in clinical drug development-an Executive Summary of the PhRMA Working Group. J Biopharm Stat. 2006;16:275-283; discussion 285-291, 293-298, 311-312.
4. Krams M, Sharma S, Dragalin V, et al. Adaptive approaches in clinical drug development: opportunities and challenges in design and implementation. Pharm Med.2009;23:139-148.
5. Orloff J, Douglas F, Pinheiro J, et al. The future of drug development: advancing clinical trial design. Nat Rev Drug Discov. 2009;8: 949-957.
6. Fardipour P, Littman G, Burns DD, et al. Planning and executing response-adaptive learn-phase clinical trials: 1. The process. Drug Info J. 2009a;43:713-723.
7. Fardipour P, Littman G, Burns DD, et al. Planning and executing response-adaptive learn-phase clinical trials: 2. Case studies. Drug Info J. 2009b;43:725-734.
8. Millan MJ, Dekeyne A, Gobert A. Serotonin (5-HT)2C receptors tonically inhibit dopamine (DA) and noradrenaline (NA), but not 5-HT, release in the frontal cortex in vivo. Neuropharmacology.1998;37:953-955.
9. Kay SR, Fiszbein A, Opler LA. The positive and negative syndrome scale (PANSS) for schizophrenia. Schizophr Bull. 1987;13:261-276.
10. West M, Harrison J. Bayesian Forecasting and Dynamic Models, Second Edition. Springer-Verlag: New York;1997:700.
11. Papakostas GI, Fava M. Does the probability of receiving placebo influence clinical trial outcome? A meta-regression of double-blind, randomized clinical trials in MDD. Eur Neuropsychopharmacol.2009;19(1):34-40.