The Declaration of Helsinki and Clinical Trials: A Focus on Placebo-Controlled Trials in Schizophrenia
OBJECTIVE: The authors' goal was to consider ethical approaches to placebo-controlled clinical trials in the light of the evolving Declaration of Helsinki, with special attention to applications to research on schizophrenia. METHOD: They review the Helsinki position on placebos, including the 2...
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Veröffentlicht in: | The American journal of psychiatry 2003-02, Vol.160 (2), p.356-362 |
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description | OBJECTIVE: The authors' goal was to consider ethical approaches to placebo-controlled clinical trials in the light of the evolving Declaration of Helsinki, with special attention to applications to research on schizophrenia. METHOD: They review the Helsinki position on placebos, including the 2002 Clarification, exploring the potential negative effects of banning placebos in studies involving conditions for which at least partially effective treatments exist. The Clarification is examined as an approach to this issue that, in contrast to earlier formulations, better acknowledges the complexity of clinical research and the need for protocol-specific determinations. Placebo controls in schizophrenia studies are used to illustrate issues relevant to all clinical research on therapeutic interventions. RESULTS: The Helsinki Clarification provides a basis for operationalizing criteria for review of placebo use in clinical trials. Six criteria are proposed for judging the ethical acceptability of placebo controls, including the likelihood that the intervention being tested will have clinically significant advantages over existing treatments, the presence of compelling reasons for placebo use, subject selection that minimizes the possibility of serious adverse consequences, and a risk-versus-benefit analysis that favors the advantages from placebo use over the risks to subjects. CONCLUSIONS: The Helsinki Clarification constitutes an important advance in international approaches to placebo use, requiring protocol-by-protocol judgments on complex issues of clinical research ethics. When operationalized, it provides review boards with a useful methodology for reaching determinations on the appropriateness of placebo controls in particular studies. |
doi_str_mv | 10.1176/appi.ajp.160.2.356 |
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METHOD: They review the Helsinki position on placebos, including the 2002 Clarification, exploring the potential negative effects of banning placebos in studies involving conditions for which at least partially effective treatments exist. The Clarification is examined as an approach to this issue that, in contrast to earlier formulations, better acknowledges the complexity of clinical research and the need for protocol-specific determinations. Placebo controls in schizophrenia studies are used to illustrate issues relevant to all clinical research on therapeutic interventions. RESULTS: The Helsinki Clarification provides a basis for operationalizing criteria for review of placebo use in clinical trials. Six criteria are proposed for judging the ethical acceptability of placebo controls, including the likelihood that the intervention being tested will have clinically significant advantages over existing treatments, the presence of compelling reasons for placebo use, subject selection that minimizes the possibility of serious adverse consequences, and a risk-versus-benefit analysis that favors the advantages from placebo use over the risks to subjects. CONCLUSIONS: The Helsinki Clarification constitutes an important advance in international approaches to placebo use, requiring protocol-by-protocol judgments on complex issues of clinical research ethics. When operationalized, it provides review boards with a useful methodology for reaching determinations on the appropriateness of placebo controls in particular studies.</description><identifier>ISSN: 0002-953X</identifier><identifier>EISSN: 1535-7228</identifier><identifier>DOI: 10.1176/appi.ajp.160.2.356</identifier><identifier>PMID: 12562584</identifier><identifier>CODEN: AJPSAO</identifier><language>eng</language><publisher>Washington, DC: American Psychiatric Publishing</publisher><subject>Bioethics ; Biological and medical sciences ; Clinical trials ; Controlled Clinical Trials as Topic - legislation & jurisprudence ; Controlled Clinical Trials as Topic - standards ; Ethics Committees, Research - standards ; Helsinki Declaration ; Humans ; Legislation ; Medical ethics ; Medical research ; Medical sciences ; Mental health ; Placebos - administration & dosage ; Psychology. Psychoanalysis. Psychiatry ; Psychopathology. Psychiatry ; Research Design - legislation & jurisprudence ; Research Design - standards ; Schizophrenia ; Schizophrenia - drug therapy ; Social psychiatry. Ethnopsychiatry ; Studies</subject><ispartof>The American journal of psychiatry, 2003-02, Vol.160 (2), p.356-362</ispartof><rights>2003 INIST-CNRS</rights><rights>Copyright American Psychiatric Association Feb 2003</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-a462t-3f3026a68c64b36bcf2601406053c0624269e52d90fbaa29b479d48e9c6e71603</citedby><cites>FETCH-LOGICAL-a462t-3f3026a68c64b36bcf2601406053c0624269e52d90fbaa29b479d48e9c6e71603</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://psychiatryonline.org/doi/epdf/10.1176/appi.ajp.160.2.356$$EPDF$$P50$$Gappi$$H</linktopdf><linktohtml>$$Uhttps://psychiatryonline.org/doi/full/10.1176/appi.ajp.160.2.356$$EHTML$$P50$$Gappi$$H</linktohtml><link.rule.ids>314,780,784,2855,21626,21627,21628,27924,27925,77794,77799</link.rule.ids><backlink>$$Uhttp://pascal-francis.inist.fr/vibad/index.php?action=getRecordDetail&idt=14514658$$DView record in Pascal Francis$$Hfree_for_read</backlink><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/12562584$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Carpenter, William T.</creatorcontrib><creatorcontrib>Appelbaum, Paul S.</creatorcontrib><creatorcontrib>Levine, Robert J.</creatorcontrib><title>The Declaration of Helsinki and Clinical Trials: A Focus on Placebo-Controlled Trials in Schizophrenia</title><title>The American journal of psychiatry</title><addtitle>Am J Psychiatry</addtitle><description>OBJECTIVE: The authors' goal was to consider ethical approaches to placebo-controlled clinical trials in the light of the evolving Declaration of Helsinki, with special attention to applications to research on schizophrenia. METHOD: They review the Helsinki position on placebos, including the 2002 Clarification, exploring the potential negative effects of banning placebos in studies involving conditions for which at least partially effective treatments exist. The Clarification is examined as an approach to this issue that, in contrast to earlier formulations, better acknowledges the complexity of clinical research and the need for protocol-specific determinations. Placebo controls in schizophrenia studies are used to illustrate issues relevant to all clinical research on therapeutic interventions. RESULTS: The Helsinki Clarification provides a basis for operationalizing criteria for review of placebo use in clinical trials. Six criteria are proposed for judging the ethical acceptability of placebo controls, including the likelihood that the intervention being tested will have clinically significant advantages over existing treatments, the presence of compelling reasons for placebo use, subject selection that minimizes the possibility of serious adverse consequences, and a risk-versus-benefit analysis that favors the advantages from placebo use over the risks to subjects. CONCLUSIONS: The Helsinki Clarification constitutes an important advance in international approaches to placebo use, requiring protocol-by-protocol judgments on complex issues of clinical research ethics. When operationalized, it provides review boards with a useful methodology for reaching determinations on the appropriateness of placebo controls in particular studies.</description><subject>Bioethics</subject><subject>Biological and medical sciences</subject><subject>Clinical trials</subject><subject>Controlled Clinical Trials as Topic - legislation & jurisprudence</subject><subject>Controlled Clinical Trials as Topic - standards</subject><subject>Ethics Committees, Research - standards</subject><subject>Helsinki Declaration</subject><subject>Humans</subject><subject>Legislation</subject><subject>Medical ethics</subject><subject>Medical research</subject><subject>Medical sciences</subject><subject>Mental health</subject><subject>Placebos - administration & dosage</subject><subject>Psychology. Psychoanalysis. Psychiatry</subject><subject>Psychopathology. Psychiatry</subject><subject>Research Design - legislation & jurisprudence</subject><subject>Research Design - standards</subject><subject>Schizophrenia</subject><subject>Schizophrenia - drug therapy</subject><subject>Social psychiatry. Ethnopsychiatry</subject><subject>Studies</subject><issn>0002-953X</issn><issn>1535-7228</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2003</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNp9kU9v1DAQxS1ERbeFL8ABWUjtLak9_pOEW7VQWqkSSCwSN8txHK0Xrx3szQE-fV02ohKHnkYz-s280XsIvaWkprSRV3qaXK13U00lqaFmQr5AKyqYqBqA9iVaEUKg6gT7cYrOct6VlrAGXqFTCkKCaPkKjZutxR-t8Trpg4sBxxHfWp9d-OmwDgNeexec0R5vktM-f8DX-CaaOePCfvXa2D5W6xgOKXpvh4XCLuBvZuv-xGmbbHD6NToZy9y-Weo5-n7zabO-re6_fL5bX99Xmks4VGxkBKSWrZG8Z7I3I0hCOZFEMEMkcJCdFTB0ZOy1hq7nTTfw1nZG2qa4wM7R5fHulOKv2eaD2rtsrPc62Dhn1UDXMcahgO__A3dxTqH8pgAIbyTlokBwhEyKOSc7qim5vU6_FSXqMQL1GIEqEagirkCVCMrSu-Xy3O_t8LSyeF6AiwXQuRg7Jh2My08cF5RL0Rbu6sj9Ffn33jPSD-Vbnr4</recordid><startdate>20030201</startdate><enddate>20030201</enddate><creator>Carpenter, William T.</creator><creator>Appelbaum, Paul S.</creator><creator>Levine, Robert J.</creator><general>American Psychiatric Publishing</general><general>American Psychiatric Association</general><scope>IQODW</scope><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>7X8</scope></search><sort><creationdate>20030201</creationdate><title>The Declaration of Helsinki and Clinical Trials: A Focus on Placebo-Controlled Trials in Schizophrenia</title><author>Carpenter, William T. ; Appelbaum, Paul S. ; Levine, Robert J.</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-a462t-3f3026a68c64b36bcf2601406053c0624269e52d90fbaa29b479d48e9c6e71603</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2003</creationdate><topic>Bioethics</topic><topic>Biological and medical sciences</topic><topic>Clinical trials</topic><topic>Controlled Clinical Trials as Topic - legislation & jurisprudence</topic><topic>Controlled Clinical Trials as Topic - standards</topic><topic>Ethics Committees, Research - standards</topic><topic>Helsinki Declaration</topic><topic>Humans</topic><topic>Legislation</topic><topic>Medical ethics</topic><topic>Medical research</topic><topic>Medical sciences</topic><topic>Mental health</topic><topic>Placebos - administration & dosage</topic><topic>Psychology. Psychoanalysis. Psychiatry</topic><topic>Psychopathology. Psychiatry</topic><topic>Research Design - legislation & jurisprudence</topic><topic>Research Design - standards</topic><topic>Schizophrenia</topic><topic>Schizophrenia - drug therapy</topic><topic>Social psychiatry. Ethnopsychiatry</topic><topic>Studies</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Carpenter, William T.</creatorcontrib><creatorcontrib>Appelbaum, Paul S.</creatorcontrib><creatorcontrib>Levine, Robert J.</creatorcontrib><collection>Pascal-Francis</collection><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>MEDLINE - Academic</collection><jtitle>The American journal of psychiatry</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Carpenter, William T.</au><au>Appelbaum, Paul S.</au><au>Levine, Robert J.</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>The Declaration of Helsinki and Clinical Trials: A Focus on Placebo-Controlled Trials in Schizophrenia</atitle><jtitle>The American journal of psychiatry</jtitle><addtitle>Am J Psychiatry</addtitle><date>2003-02-01</date><risdate>2003</risdate><volume>160</volume><issue>2</issue><spage>356</spage><epage>362</epage><pages>356-362</pages><issn>0002-953X</issn><eissn>1535-7228</eissn><coden>AJPSAO</coden><abstract>OBJECTIVE: The authors' goal was to consider ethical approaches to placebo-controlled clinical trials in the light of the evolving Declaration of Helsinki, with special attention to applications to research on schizophrenia. METHOD: They review the Helsinki position on placebos, including the 2002 Clarification, exploring the potential negative effects of banning placebos in studies involving conditions for which at least partially effective treatments exist. The Clarification is examined as an approach to this issue that, in contrast to earlier formulations, better acknowledges the complexity of clinical research and the need for protocol-specific determinations. Placebo controls in schizophrenia studies are used to illustrate issues relevant to all clinical research on therapeutic interventions. RESULTS: The Helsinki Clarification provides a basis for operationalizing criteria for review of placebo use in clinical trials. Six criteria are proposed for judging the ethical acceptability of placebo controls, including the likelihood that the intervention being tested will have clinically significant advantages over existing treatments, the presence of compelling reasons for placebo use, subject selection that minimizes the possibility of serious adverse consequences, and a risk-versus-benefit analysis that favors the advantages from placebo use over the risks to subjects. CONCLUSIONS: The Helsinki Clarification constitutes an important advance in international approaches to placebo use, requiring protocol-by-protocol judgments on complex issues of clinical research ethics. When operationalized, it provides review boards with a useful methodology for reaching determinations on the appropriateness of placebo controls in particular studies.</abstract><cop>Washington, DC</cop><pub>American Psychiatric Publishing</pub><pmid>12562584</pmid><doi>10.1176/appi.ajp.160.2.356</doi><tpages>7</tpages></addata></record> |
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subjects | Bioethics Biological and medical sciences Clinical trials Controlled Clinical Trials as Topic - legislation & jurisprudence Controlled Clinical Trials as Topic - standards Ethics Committees, Research - standards Helsinki Declaration Humans Legislation Medical ethics Medical research Medical sciences Mental health Placebos - administration & dosage Psychology. Psychoanalysis. Psychiatry Psychopathology. Psychiatry Research Design - legislation & jurisprudence Research Design - standards Schizophrenia Schizophrenia - drug therapy Social psychiatry. Ethnopsychiatry Studies |
title | The Declaration of Helsinki and Clinical Trials: A Focus on Placebo-Controlled Trials in Schizophrenia |
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