How Adaptive Trial Designs Can Increase Efficiency in Psychiatric Drug Development: A Case Study.
This paper uses a recently completed study to illustrate how adaptive trial designs can increase efficiency of psychiatric drug development. The design employed allowed a continuous reassessment of the estimated dose-response such that patients were randomized in a double-blind fashion to one of sev...
| Publicado en: | Innovations in Clinical Neuroscience Vol. 8; no. 7; pp. 26 - 35 |
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| Autores principales: | , , , , , , , |
| Formato: | case study clinical trial research tables/charts Journal Article |
| Publicado: |
Matrix Medical Communications, LLC
Jul2011
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| Acceso en línea: | Ver este registro en EBSCOhost |
| fields | @attributes: recordID: 1 pdfLink: plink: https://search.ebscohost.com/login.aspx?direct=true&db=ccm&AN=65412041&site=ehost-live header: @attributes: shortDbName: ccm uiTerm: 65412041 longDbName: CINAHL Complete uiTag: AN controlInfo: bkinfo: dissinfo: jinfo: jid: 21588333 DAD5 jtl: Innovations in Clinical Neuroscience issn: 21588333 maglogo: N pubinfo: dt: Jul2011 vid: 8 iid: 7 pid: 33670 pub: Matrix Medical Communications, LLC place: West Chester, Pennsylvania artinfo: ui: 65412041 65412041 104689709 65412041 ppf: 26 ppct: 9 formats: fmt: @attributes: type: P tig: atl: How Adaptive Trial Designs Can Increase Efficiency in Psychiatric Drug Development: A Case Study. aug: au: SHEN, JOAN PRESKORN, SHELDON DRAGALIN, VLADIMIR SLOMKOWSKI, MARY PADMANABHAN, S. KRISHNA FARDIPOUR, PARVIN SHARMA, AMARNATH KRAMS, MICHAEL affil: Senior Director, Pfizer Inc., Collegeville, Pennsylvania sug: subj: Drug Design Antipsychotic Agents Therapeutic Use Clinical Trials Antipsychotic Agents Administration and Dosage Schizophrenia Drug Therapy Drugs, Investigational Risperidone Administration and Dosage Descriptive Statistics Human Simulations United States Adult Middle Age Male Female Treatment Outcomes Dose-Response Relationship, Drug Psychological Tests Scales Adult: 19-44 years Middle Aged: 45-64 years Male Female ab: This paper uses a recently completed study to illustrate how adaptive trial designs can increase efficiency of psychiatric drug development. The design employed allowed a continuous reassessment of the estimated dose-response such that patients were randomized in a double-blind fashion to one of seven doses of the investigational drug, placebo, or active comparator. The study design also permitted early detection of futility allowing for early study termination. By using the adaptive trial design approach, only 202 patients were needed to make the determination of futility. In contrast, a conventional design would have required enrollment of 450 patients and considerably more time and expense to reach the same conclusion. Adaptive trial designs are important at this time when many pharmaceutical companies are abandoning the development of psychiatric medications because of the inefficiency of conventional approaches. pubtype: Academic Journal doctype: case study clinical trial research tables/charts Journal Article ougenre: Unknown language: English refInfo: holdings: @attributes: islocal: N |
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