Approaches to multisite clinical trials: the National Institute of Mental Health perspective
The Division of Services and Intervention Research of the National Institute of Mental Health (NIMH) utilizes a variety of methodologies and approaches in the development of its clinical trials program. In this article, we describe the need for large multisite trials; the mechanisms for addressing t...
Gespeichert in:
Veröffentlicht in: | Schizophrenia bulletin 2003, Vol.29 (1), p.7-13 |
---|---|
Hauptverfasser: | , , |
Format: | Artikel |
Sprache: | eng |
Schlagworte: | |
Online-Zugang: | Volltext |
Tags: |
Tag hinzufügen
Keine Tags, Fügen Sie den ersten Tag hinzu!
|
container_end_page | 13 |
---|---|
container_issue | 1 |
container_start_page | 7 |
container_title | Schizophrenia bulletin |
container_volume | 29 |
creator | Lebowitz, Barry D Vitiello, Benedetto Norquist, Grayson S |
description | The Division of Services and Intervention Research of the National Institute of Mental Health (NIMH) utilizes a variety of methodologies and approaches in the development of its clinical trials program. In this article, we describe the need for large multisite trials; the mechanisms for addressing this need; and the various approaches that have been used. In the course of carrying out this initiative, we have created opportunities for the Institute and its trial investigators to receive advice and input from the field. We describe the role and function of the trial coordinating center and NIMH staff. We identify the first steps to be taken in the initiation of a trial and highlight the opportunity for ancillary studies. Finally, we enumerate some of the pitfalls of large clinical trials and discuss measures taken to anticipate and address them. |
doi_str_mv | 10.1093/oxfordjournals.schbul.a006992 |
format | Article |
fullrecord | <record><control><sourceid>proquest_cross</sourceid><recordid>TN_cdi_proquest_miscellaneous_73556448</recordid><sourceformat>XML</sourceformat><sourcesystem>PC</sourcesystem><sourcerecordid>73556448</sourcerecordid><originalsourceid>FETCH-LOGICAL-c430t-68af1f77d69301c8ad7f238ec4d5103b098eecdf2c5a8bea12f3bcbd725b2ec3</originalsourceid><addsrcrecordid>eNp9kc1q3DAUhUVo6EwmfYUgAu3OE_1YlhzIIoTmB9Jmk2VByPIVo8FjOZJc2rePwkwp7SIrweU796D7IfSZkjUlLb8Iv1yI_TbMcTRDWie76eZhbQhp2pYdoSWVtaioJPQDWhKhmko2tF6gk5S2hNC6bdhHtKCsJaoRcol-XE9TDMZuIOEc8G4esk8-A7aDH701A87Rl6JLnDeAv5vsQ-nFD2PKPs-FCw5_gzGX2T2YIW_wBDFNYLP_Cafo2JUsfDq8K_R8-_X55r56fLp7uLl-rGzNSa4aZRx1UvZNywm1yvTSMa7A1r2ghHekVQC2d8wKozowlDne2a6XTHQMLF-hL_u15ScvM6Ssdz5ZGAYzQpiTllyIpq5VAc__A__cUZcjcVWLlr0HMVY2cVk0rNDVHrIxpBTB6Sn6nYm_NSX6zZP-15Pee9IHTyV_diiZux30f9MHMfwVlEKYHw</addsrcrecordid><sourcetype>Aggregation Database</sourcetype><iscdi>true</iscdi><recordtype>article</recordtype><pqid>614384592</pqid></control><display><type>article</type><title>Approaches to multisite clinical trials: the National Institute of Mental Health perspective</title><source>MEDLINE</source><source>EBSCOhost APA PsycARTICLES</source><source>EZB-FREE-00999 freely available EZB journals</source><source>Alma/SFX Local Collection</source><source>Oxford Journals</source><creator>Lebowitz, Barry D ; Vitiello, Benedetto ; Norquist, Grayson S</creator><creatorcontrib>Lebowitz, Barry D ; Vitiello, Benedetto ; Norquist, Grayson S</creatorcontrib><description>The Division of Services and Intervention Research of the National Institute of Mental Health (NIMH) utilizes a variety of methodologies and approaches in the development of its clinical trials program. In this article, we describe the need for large multisite trials; the mechanisms for addressing this need; and the various approaches that have been used. In the course of carrying out this initiative, we have created opportunities for the Institute and its trial investigators to receive advice and input from the field. We describe the role and function of the trial coordinating center and NIMH staff. We identify the first steps to be taken in the initiation of a trial and highlight the opportunity for ancillary studies. Finally, we enumerate some of the pitfalls of large clinical trials and discuss measures taken to anticipate and address them.</description><identifier>ISSN: 0586-7614</identifier><identifier>EISSN: 1745-1701</identifier><identifier>DOI: 10.1093/oxfordjournals.schbul.a006992</identifier><identifier>PMID: 12908657</identifier><language>eng</language><publisher>United States: Oxford Publishing Limited (England)</publisher><subject>Clinical Trials ; Clinical Trials as Topic - standards ; Empirical Methods ; Experimental Design ; Human ; Humans ; Mental Disorders - therapy ; Mental Health Services - organization & administration ; Multicenter Studies as Topic - standards ; National Institute of Mental Health (U.S.) ; Professional Organizations ; Public Health ; United States</subject><ispartof>Schizophrenia bulletin, 2003, Vol.29 (1), p.7-13</ispartof><rights>Copyright Superintendent of Documents 2003</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c430t-68af1f77d69301c8ad7f238ec4d5103b098eecdf2c5a8bea12f3bcbd725b2ec3</citedby></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><link.rule.ids>314,776,780,4009,27902,27903,27904</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/12908657$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Lebowitz, Barry D</creatorcontrib><creatorcontrib>Vitiello, Benedetto</creatorcontrib><creatorcontrib>Norquist, Grayson S</creatorcontrib><title>Approaches to multisite clinical trials: the National Institute of Mental Health perspective</title><title>Schizophrenia bulletin</title><addtitle>Schizophr Bull</addtitle><description>The Division of Services and Intervention Research of the National Institute of Mental Health (NIMH) utilizes a variety of methodologies and approaches in the development of its clinical trials program. In this article, we describe the need for large multisite trials; the mechanisms for addressing this need; and the various approaches that have been used. In the course of carrying out this initiative, we have created opportunities for the Institute and its trial investigators to receive advice and input from the field. We describe the role and function of the trial coordinating center and NIMH staff. We identify the first steps to be taken in the initiation of a trial and highlight the opportunity for ancillary studies. Finally, we enumerate some of the pitfalls of large clinical trials and discuss measures taken to anticipate and address them.</description><subject>Clinical Trials</subject><subject>Clinical Trials as Topic - standards</subject><subject>Empirical Methods</subject><subject>Experimental Design</subject><subject>Human</subject><subject>Humans</subject><subject>Mental Disorders - therapy</subject><subject>Mental Health Services - organization & administration</subject><subject>Multicenter Studies as Topic - standards</subject><subject>National Institute of Mental Health (U.S.)</subject><subject>Professional Organizations</subject><subject>Public Health</subject><subject>United States</subject><issn>0586-7614</issn><issn>1745-1701</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2003</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNp9kc1q3DAUhUVo6EwmfYUgAu3OE_1YlhzIIoTmB9Jmk2VByPIVo8FjOZJc2rePwkwp7SIrweU796D7IfSZkjUlLb8Iv1yI_TbMcTRDWie76eZhbQhp2pYdoSWVtaioJPQDWhKhmko2tF6gk5S2hNC6bdhHtKCsJaoRcol-XE9TDMZuIOEc8G4esk8-A7aDH701A87Rl6JLnDeAv5vsQ-nFD2PKPs-FCw5_gzGX2T2YIW_wBDFNYLP_Cafo2JUsfDq8K_R8-_X55r56fLp7uLl-rGzNSa4aZRx1UvZNywm1yvTSMa7A1r2ghHekVQC2d8wKozowlDne2a6XTHQMLF-hL_u15ScvM6Ssdz5ZGAYzQpiTllyIpq5VAc__A__cUZcjcVWLlr0HMVY2cVk0rNDVHrIxpBTB6Sn6nYm_NSX6zZP-15Pee9IHTyV_diiZux30f9MHMfwVlEKYHw</recordid><startdate>2003</startdate><enddate>2003</enddate><creator>Lebowitz, Barry D</creator><creator>Vitiello, Benedetto</creator><creator>Norquist, Grayson S</creator><general>Oxford Publishing Limited (England)</general><general>National Institute of Mental Health</general><scope>CGR</scope><scope>CUY</scope><scope>CVF</scope><scope>ECM</scope><scope>EIF</scope><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>K9.</scope><scope>NAPCQ</scope><scope>7RZ</scope><scope>PSYQQ</scope><scope>7X8</scope></search><sort><creationdate>2003</creationdate><title>Approaches to multisite clinical trials: the National Institute of Mental Health perspective</title><author>Lebowitz, Barry D ; Vitiello, Benedetto ; Norquist, Grayson S</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c430t-68af1f77d69301c8ad7f238ec4d5103b098eecdf2c5a8bea12f3bcbd725b2ec3</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2003</creationdate><topic>Clinical Trials</topic><topic>Clinical Trials as Topic - standards</topic><topic>Empirical Methods</topic><topic>Experimental Design</topic><topic>Human</topic><topic>Humans</topic><topic>Mental Disorders - therapy</topic><topic>Mental Health Services - organization & administration</topic><topic>Multicenter Studies as Topic - standards</topic><topic>National Institute of Mental Health (U.S.)</topic><topic>Professional Organizations</topic><topic>Public Health</topic><topic>United States</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Lebowitz, Barry D</creatorcontrib><creatorcontrib>Vitiello, Benedetto</creatorcontrib><creatorcontrib>Norquist, Grayson S</creatorcontrib><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>ProQuest Health & Medical Complete (Alumni)</collection><collection>Nursing & Allied Health Premium</collection><collection>APA PsycArticles®</collection><collection>ProQuest One Psychology</collection><collection>MEDLINE - Academic</collection><jtitle>Schizophrenia bulletin</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Lebowitz, Barry D</au><au>Vitiello, Benedetto</au><au>Norquist, Grayson S</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Approaches to multisite clinical trials: the National Institute of Mental Health perspective</atitle><jtitle>Schizophrenia bulletin</jtitle><addtitle>Schizophr Bull</addtitle><date>2003</date><risdate>2003</risdate><volume>29</volume><issue>1</issue><spage>7</spage><epage>13</epage><pages>7-13</pages><issn>0586-7614</issn><eissn>1745-1701</eissn><abstract>The Division of Services and Intervention Research of the National Institute of Mental Health (NIMH) utilizes a variety of methodologies and approaches in the development of its clinical trials program. In this article, we describe the need for large multisite trials; the mechanisms for addressing this need; and the various approaches that have been used. In the course of carrying out this initiative, we have created opportunities for the Institute and its trial investigators to receive advice and input from the field. We describe the role and function of the trial coordinating center and NIMH staff. We identify the first steps to be taken in the initiation of a trial and highlight the opportunity for ancillary studies. Finally, we enumerate some of the pitfalls of large clinical trials and discuss measures taken to anticipate and address them.</abstract><cop>United States</cop><pub>Oxford Publishing Limited (England)</pub><pmid>12908657</pmid><doi>10.1093/oxfordjournals.schbul.a006992</doi><tpages>7</tpages><oa>free_for_read</oa></addata></record> |
fulltext | fulltext |
identifier | ISSN: 0586-7614 |
ispartof | Schizophrenia bulletin, 2003, Vol.29 (1), p.7-13 |
issn | 0586-7614 1745-1701 |
language | eng |
recordid | cdi_proquest_miscellaneous_73556448 |
source | MEDLINE; EBSCOhost APA PsycARTICLES; EZB-FREE-00999 freely available EZB journals; Alma/SFX Local Collection; Oxford Journals |
subjects | Clinical Trials Clinical Trials as Topic - standards Empirical Methods Experimental Design Human Humans Mental Disorders - therapy Mental Health Services - organization & administration Multicenter Studies as Topic - standards National Institute of Mental Health (U.S.) Professional Organizations Public Health United States |
title | Approaches to multisite clinical trials: the National Institute of Mental Health perspective |
url | https://sfx.bib-bvb.de/sfx_tum?ctx_ver=Z39.88-2004&ctx_enc=info:ofi/enc:UTF-8&ctx_tim=2025-01-22T20%3A58%3A51IST&url_ver=Z39.88-2004&url_ctx_fmt=infofi/fmt:kev:mtx:ctx&rfr_id=info:sid/primo.exlibrisgroup.com:primo3-Article-proquest_cross&rft_val_fmt=info:ofi/fmt:kev:mtx:journal&rft.genre=article&rft.atitle=Approaches%20to%20multisite%20clinical%20trials:%20the%20National%20Institute%20of%20Mental%20Health%20perspective&rft.jtitle=Schizophrenia%20bulletin&rft.au=Lebowitz,%20Barry%20D&rft.date=2003&rft.volume=29&rft.issue=1&rft.spage=7&rft.epage=13&rft.pages=7-13&rft.issn=0586-7614&rft.eissn=1745-1701&rft_id=info:doi/10.1093/oxfordjournals.schbul.a006992&rft_dat=%3Cproquest_cross%3E73556448%3C/proquest_cross%3E%3Curl%3E%3C/url%3E&disable_directlink=true&sfx.directlink=off&sfx.report_link=0&rft_id=info:oai/&rft_pqid=614384592&rft_id=info:pmid/12908657&rfr_iscdi=true |