Principles of Good Clinical Trial Design
Clinical trials are a fundamental component of medical research and serve as the main route to obtain evidence of the safety and efficacy of treatment before its approval. A trial’s ability to provide the intended evidence hinges on appropriate design, background knowledge, trial rationale to sample...
Gespeichert in:
| Veröffentlicht in: | Journal of thoracic oncology 2020-08, Vol.15 (8), p.1277-1280 |
|---|---|
| Hauptverfasser: | , , , |
| Format: | Artikel |
| Sprache: | eng |
| Schlagworte: | |
| Online-Zugang: | Volltext |
| Tags: |
Tag hinzufügen
Keine Tags, Fügen Sie den ersten Tag hinzu!
|
| container_end_page | 1280 |
|---|---|
| container_issue | 8 |
| container_start_page | 1277 |
| container_title | Journal of thoracic oncology |
| container_volume | 15 |
| creator | An, Ming-Wen Duong, Quyen Le-Rademacher, Jennifer Mandrekar, Sumithra J. |
| description | Clinical trials are a fundamental component of medical research and serve as the main route to obtain evidence of the safety and efficacy of treatment before its approval. A trial’s ability to provide the intended evidence hinges on appropriate design, background knowledge, trial rationale to sample size, and interim monitoring rules. In this article, we present some general design principles for investigators and their research teams to consider when planning to conduct a trial. |
| doi_str_mv | 10.1016/j.jtho.2020.05.005 |
| format | Article |
| fullrecord | <record><control><sourceid>proquest_pubme</sourceid><recordid>TN_cdi_pubmedcentral_primary_oai_pubmedcentral_nih_gov_7390662</recordid><sourceformat>XML</sourceformat><sourcesystem>PC</sourcesystem><els_id>S1556086420303877</els_id><sourcerecordid>2404376307</sourcerecordid><originalsourceid>FETCH-LOGICAL-c5007-4be5082368fad47f926ac302fdf7a425e49996085f2519a0c080ffe1fde4ea613</originalsourceid><addsrcrecordid>eNp9kEtPGzEUha0KVCjtH-gCZclmhuvnzEgVEgo0VEKiC7q2HM81cXDGwZ6A-Pd1SIraTRd-SD7n3OOPkK8UagpUnS_r5biINQMGNcgaQH4gx1RKVVHewsH-Dq0SR-RTzksAIUG0H8kRZ4I2XPBjcvYz-cH6dcA8iW4yi7GfTIMfvDVhcp982a8w-4fhMzl0JmT8sj9PyK_v1_fTm-r2bvZjenlbWQnQVGKOElrGVetMLxrXMWUsB-Z61xjBJIqu6xS00jFJOwMWWnAOqetRoFGUn5CLXe56M19hb3EYkwl6nfzKpFcdjdf_vgx-oR_is254B0qxEnC2D0jxaYN51CufLYZgBoybrJkAwRvFoSlStpPaFHNO6N7HUNBbxHqpt4j1FrEGqQviYjr9u-C75Q_TIhA7wUsMI6b8GDYvmPQCTRgXGigTvO1Etc0snweoynor821nw0L32RdHth4Hi71PaEfdR_-_Wr8BpQqbww</addsrcrecordid><sourcetype>Open Access Repository</sourcetype><iscdi>true</iscdi><recordtype>article</recordtype><pqid>2404376307</pqid></control><display><type>article</type><title>Principles of Good Clinical Trial Design</title><source>MEDLINE</source><source>EZB-FREE-00999 freely available EZB journals</source><source>Alma/SFX Local Collection</source><creator>An, Ming-Wen ; Duong, Quyen ; Le-Rademacher, Jennifer ; Mandrekar, Sumithra J.</creator><creatorcontrib>An, Ming-Wen ; Duong, Quyen ; Le-Rademacher, Jennifer ; Mandrekar, Sumithra J.</creatorcontrib><description>Clinical trials are a fundamental component of medical research and serve as the main route to obtain evidence of the safety and efficacy of treatment before its approval. A trial’s ability to provide the intended evidence hinges on appropriate design, background knowledge, trial rationale to sample size, and interim monitoring rules. In this article, we present some general design principles for investigators and their research teams to consider when planning to conduct a trial.</description><identifier>ISSN: 1556-0864</identifier><identifier>EISSN: 1556-1380</identifier><identifier>DOI: 10.1016/j.jtho.2020.05.005</identifier><identifier>PMID: 32417343</identifier><language>eng</language><publisher>United States: Elsevier Inc</publisher><subject>Biomedical Research ; Clinical trial ; Clinical Trials as Topic ; Collaboration ; Design ; Humans ; Lung Neoplasms ; Principles ; Research Design</subject><ispartof>Journal of thoracic oncology, 2020-08, Vol.15 (8), p.1277-1280</ispartof><rights>2020 International Association for the Study of Lung Cancer</rights><rights>Copyright © 2020 by the International Association for the Study of Lung Cancer</rights><rights>Copyright © 2020 International Association for the Study of Lung Cancer. Published by Elsevier Inc. All rights reserved.</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c5007-4be5082368fad47f926ac302fdf7a425e49996085f2519a0c080ffe1fde4ea613</citedby><cites>FETCH-LOGICAL-c5007-4be5082368fad47f926ac302fdf7a425e49996085f2519a0c080ffe1fde4ea613</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><link.rule.ids>230,314,780,784,885,27924,27925</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/32417343$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>An, Ming-Wen</creatorcontrib><creatorcontrib>Duong, Quyen</creatorcontrib><creatorcontrib>Le-Rademacher, Jennifer</creatorcontrib><creatorcontrib>Mandrekar, Sumithra J.</creatorcontrib><title>Principles of Good Clinical Trial Design</title><title>Journal of thoracic oncology</title><addtitle>J Thorac Oncol</addtitle><description>Clinical trials are a fundamental component of medical research and serve as the main route to obtain evidence of the safety and efficacy of treatment before its approval. A trial’s ability to provide the intended evidence hinges on appropriate design, background knowledge, trial rationale to sample size, and interim monitoring rules. In this article, we present some general design principles for investigators and their research teams to consider when planning to conduct a trial.</description><subject>Biomedical Research</subject><subject>Clinical trial</subject><subject>Clinical Trials as Topic</subject><subject>Collaboration</subject><subject>Design</subject><subject>Humans</subject><subject>Lung Neoplasms</subject><subject>Principles</subject><subject>Research Design</subject><issn>1556-0864</issn><issn>1556-1380</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2020</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNp9kEtPGzEUha0KVCjtH-gCZclmhuvnzEgVEgo0VEKiC7q2HM81cXDGwZ6A-Pd1SIraTRd-SD7n3OOPkK8UagpUnS_r5biINQMGNcgaQH4gx1RKVVHewsH-Dq0SR-RTzksAIUG0H8kRZ4I2XPBjcvYz-cH6dcA8iW4yi7GfTIMfvDVhcp982a8w-4fhMzl0JmT8sj9PyK_v1_fTm-r2bvZjenlbWQnQVGKOElrGVetMLxrXMWUsB-Z61xjBJIqu6xS00jFJOwMWWnAOqetRoFGUn5CLXe56M19hb3EYkwl6nfzKpFcdjdf_vgx-oR_is254B0qxEnC2D0jxaYN51CufLYZgBoybrJkAwRvFoSlStpPaFHNO6N7HUNBbxHqpt4j1FrEGqQviYjr9u-C75Q_TIhA7wUsMI6b8GDYvmPQCTRgXGigTvO1Etc0snweoynor821nw0L32RdHth4Hi71PaEfdR_-_Wr8BpQqbww</recordid><startdate>202008</startdate><enddate>202008</enddate><creator>An, Ming-Wen</creator><creator>Duong, Quyen</creator><creator>Le-Rademacher, Jennifer</creator><creator>Mandrekar, Sumithra J.</creator><general>Elsevier Inc</general><general>Copyright by the International Association for the Study of Lung Cancer</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>7X8</scope><scope>5PM</scope></search><sort><creationdate>202008</creationdate><title>Principles of Good Clinical Trial Design</title><author>An, Ming-Wen ; Duong, Quyen ; Le-Rademacher, Jennifer ; Mandrekar, Sumithra J.</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c5007-4be5082368fad47f926ac302fdf7a425e49996085f2519a0c080ffe1fde4ea613</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2020</creationdate><topic>Biomedical Research</topic><topic>Clinical trial</topic><topic>Clinical Trials as Topic</topic><topic>Collaboration</topic><topic>Design</topic><topic>Humans</topic><topic>Lung Neoplasms</topic><topic>Principles</topic><topic>Research Design</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>An, Ming-Wen</creatorcontrib><creatorcontrib>Duong, Quyen</creatorcontrib><creatorcontrib>Le-Rademacher, Jennifer</creatorcontrib><creatorcontrib>Mandrekar, Sumithra J.</creatorcontrib><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>MEDLINE - Academic</collection><collection>PubMed Central (Full Participant titles)</collection><jtitle>Journal of thoracic oncology</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>An, Ming-Wen</au><au>Duong, Quyen</au><au>Le-Rademacher, Jennifer</au><au>Mandrekar, Sumithra J.</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Principles of Good Clinical Trial Design</atitle><jtitle>Journal of thoracic oncology</jtitle><addtitle>J Thorac Oncol</addtitle><date>2020-08</date><risdate>2020</risdate><volume>15</volume><issue>8</issue><spage>1277</spage><epage>1280</epage><pages>1277-1280</pages><issn>1556-0864</issn><eissn>1556-1380</eissn><abstract>Clinical trials are a fundamental component of medical research and serve as the main route to obtain evidence of the safety and efficacy of treatment before its approval. A trial’s ability to provide the intended evidence hinges on appropriate design, background knowledge, trial rationale to sample size, and interim monitoring rules. In this article, we present some general design principles for investigators and their research teams to consider when planning to conduct a trial.</abstract><cop>United States</cop><pub>Elsevier Inc</pub><pmid>32417343</pmid><doi>10.1016/j.jtho.2020.05.005</doi><tpages>4</tpages><oa>free_for_read</oa></addata></record> |
| fulltext | fulltext |
| identifier | ISSN: 1556-0864 |
| ispartof | Journal of thoracic oncology, 2020-08, Vol.15 (8), p.1277-1280 |
| issn | 1556-0864 1556-1380 |
| language | eng |
| recordid | cdi_pubmedcentral_primary_oai_pubmedcentral_nih_gov_7390662 |
| source | MEDLINE; EZB-FREE-00999 freely available EZB journals; Alma/SFX Local Collection |
| subjects | Biomedical Research Clinical trial Clinical Trials as Topic Collaboration Design Humans Lung Neoplasms Principles Research Design |
| title | Principles of Good Clinical Trial Design |
| url | https://sfx.bib-bvb.de/sfx_tum?ctx_ver=Z39.88-2004&ctx_enc=info:ofi/enc:UTF-8&ctx_tim=2025-01-01T10%3A27%3A22IST&url_ver=Z39.88-2004&url_ctx_fmt=infofi/fmt:kev:mtx:ctx&rfr_id=info:sid/primo.exlibrisgroup.com:primo3-Article-proquest_pubme&rft_val_fmt=info:ofi/fmt:kev:mtx:journal&rft.genre=article&rft.atitle=Principles%20of%20Good%20Clinical%20Trial%20Design&rft.jtitle=Journal%20of%20thoracic%20oncology&rft.au=An,%20Ming-Wen&rft.date=2020-08&rft.volume=15&rft.issue=8&rft.spage=1277&rft.epage=1280&rft.pages=1277-1280&rft.issn=1556-0864&rft.eissn=1556-1380&rft_id=info:doi/10.1016/j.jtho.2020.05.005&rft_dat=%3Cproquest_pubme%3E2404376307%3C/proquest_pubme%3E%3Curl%3E%3C/url%3E&disable_directlink=true&sfx.directlink=off&sfx.report_link=0&rft_id=info:oai/&rft_pqid=2404376307&rft_id=info:pmid/32417343&rft_els_id=S1556086420303877&rfr_iscdi=true |