A Trial Activation Initiative to Accelerate Trial Opening in an Academic Medical Center
Delays in trial opening should be considered critical for the sake of not only the sponsor but the patients, as they may result in inequities of care. The Asan Medical Center, in Seoul, Korea, implemented a trial activation initiative in July 2012, in an aim to expedite the trial initiation timeline...
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| Veröffentlicht in: | Therapeutic innovation & regulatory science 2015-03, Vol.49 (2), p.234-238 |
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| creator | Choi, Yun Jung Jeon, HyeJung Kim, Sinae In, YunJeong Park, Soo Yeon Park, MiYeon Park, Sumi Lee, YooMi Kim, Sulhwa Kim, Kyu-pyo Koo, Ha Yeong Kim, Tae Won |
| description | Delays in trial opening should be considered critical for the sake of not only the sponsor but the patients, as they may result in inequities of care. The Asan Medical Center, in Seoul, Korea, implemented a trial activation initiative in July 2012, in an aim to expedite the trial initiation timeline. Time intervals between trial initiation steps and the rate of institutional review board (IRB) and clinical trial agreement (CTA) parallel submission were assessed. A higher rate of parallel IRB and CTA submissions was observed after initiative implementation (25.5% vs 52.3%; P < .001). Initiative applications were shown to significantly accelerate the median trial opening time, from 114 to 81 days (P < .001). Strategic processing of parallel submissions greatly shortened the median time required for trial initiation from 117 to 61 days compared with sequential submissions (P < .001). A trial activation initiative including parallel IRB and CTA submissions is an effective tool for accelerating trial commencements. |
| doi_str_mv | 10.1177/2168479014554399 |
| format | Article |
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The Asan Medical Center, in Seoul, Korea, implemented a trial activation initiative in July 2012, in an aim to expedite the trial initiation timeline. Time intervals between trial initiation steps and the rate of institutional review board (IRB) and clinical trial agreement (CTA) parallel submission were assessed. A higher rate of parallel IRB and CTA submissions was observed after initiative implementation (25.5% vs 52.3%; P < .001). Initiative applications were shown to significantly accelerate the median trial opening time, from 114 to 81 days (P < .001). Strategic processing of parallel submissions greatly shortened the median time required for trial initiation from 117 to 61 days compared with sequential submissions (P < .001). A trial activation initiative including parallel IRB and CTA submissions is an effective tool for accelerating trial commencements.</description><identifier>ISSN: 2168-4790</identifier><identifier>EISSN: 2168-4804</identifier><identifier>DOI: 10.1177/2168479014554399</identifier><identifier>PMID: 30222419</identifier><language>eng</language><publisher>Los Angeles, CA: SAGE Publications</publisher><subject>Accreditation ; Clinical Trials ; Contract negotiations ; Corporate sponsorship ; Drug Safety and Pharmacovigilance ; Pharmaceutical industry ; Pharmacotherapy ; Pharmacy ; Studies</subject><ispartof>Therapeutic innovation & regulatory science, 2015-03, Vol.49 (2), p.234-238</ispartof><rights>The Author(s) 2014</rights><rights>Drug Information Association, Inc 2014</rights><rights>Copyright Drug Information Association Mar 2015</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c407t-292f8f87ef354872306cbaee0b2355b5455709521ad7c270032f8c76f5aa6db23</citedby><cites>FETCH-LOGICAL-c407t-292f8f87ef354872306cbaee0b2355b5455709521ad7c270032f8c76f5aa6db23</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://journals.sagepub.com/doi/pdf/10.1177/2168479014554399$$EPDF$$P50$$Gsage$$H</linktopdf><linktohtml>$$Uhttps://journals.sagepub.com/doi/10.1177/2168479014554399$$EHTML$$P50$$Gsage$$H</linktohtml><link.rule.ids>314,776,780,21798,27901,27902,41464,42533,43597,43598,51294</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/30222419$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Choi, Yun Jung</creatorcontrib><creatorcontrib>Jeon, HyeJung</creatorcontrib><creatorcontrib>Kim, Sinae</creatorcontrib><creatorcontrib>In, YunJeong</creatorcontrib><creatorcontrib>Park, Soo Yeon</creatorcontrib><creatorcontrib>Park, MiYeon</creatorcontrib><creatorcontrib>Park, Sumi</creatorcontrib><creatorcontrib>Lee, YooMi</creatorcontrib><creatorcontrib>Kim, Sulhwa</creatorcontrib><creatorcontrib>Kim, Kyu-pyo</creatorcontrib><creatorcontrib>Koo, Ha Yeong</creatorcontrib><creatorcontrib>Kim, Tae Won</creatorcontrib><title>A Trial Activation Initiative to Accelerate Trial Opening in an Academic Medical Center</title><title>Therapeutic innovation & regulatory science</title><addtitle>Ther Innov Regul Sci</addtitle><addtitle>Ther Innov Regul Sci</addtitle><description>Delays in trial opening should be considered critical for the sake of not only the sponsor but the patients, as they may result in inequities of care. 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A trial activation initiative including parallel IRB and CTA submissions is an effective tool for accelerating trial commencements.</description><subject>Accreditation</subject><subject>Clinical Trials</subject><subject>Contract negotiations</subject><subject>Corporate sponsorship</subject><subject>Drug Safety and Pharmacovigilance</subject><subject>Pharmaceutical industry</subject><subject>Pharmacotherapy</subject><subject>Pharmacy</subject><subject>Studies</subject><issn>2168-4790</issn><issn>2168-4804</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2015</creationdate><recordtype>article</recordtype><sourceid>8G5</sourceid><sourceid>BEC</sourceid><sourceid>BENPR</sourceid><sourceid>GUQSH</sourceid><sourceid>M2O</sourceid><recordid>eNqNkM9LwzAUx4MobszdPUnBi5dqfjbtcQx_wWSXiceSpq8jo01n0g78781YJzIQzCWPfD_v-16-CF0TfE-IlA-UJCmXGSZcCM6y7AyN908xTzE_P9ZBH6Gp9xscTpYKSdNLNGKYUspJNkYfs2jljKqjme7MTnWmtdGrNZ0J5Q6irg2Chhqc6mAgl1uwxq4jYyNlg6xKaIyO3qA0OshzsB24K3RRqdrDdLgn6P3pcTV_iRfL59f5bBFrjmUX04xWaZVKqJjgqaQMJ7pQALigTIhChK9JnAlKVCk1lRizwGuZVEKppAzQBN0dfLeu_ezBd3ljfFi4Vhba3ueU4IwxTBIS0NsTdNP2zobtcpIknAqKmQgUPlDatd47qPKtM41yXznB-T73_DT30HIzGPdFA-VPwzHlAJAD4INk1-B-Tf7bNB561Br-wX8D7fSV4Q</recordid><startdate>20150301</startdate><enddate>20150301</enddate><creator>Choi, Yun Jung</creator><creator>Jeon, HyeJung</creator><creator>Kim, Sinae</creator><creator>In, YunJeong</creator><creator>Park, Soo Yeon</creator><creator>Park, MiYeon</creator><creator>Park, Sumi</creator><creator>Lee, YooMi</creator><creator>Kim, Sulhwa</creator><creator>Kim, Kyu-pyo</creator><creator>Koo, Ha Yeong</creator><creator>Kim, Tae Won</creator><general>SAGE Publications</general><general>Springer International Publishing</general><general>Springer Nature B.V</general><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>3V.</scope><scope>7RV</scope><scope>7U7</scope><scope>7X7</scope><scope>7XB</scope><scope>88I</scope><scope>8AF</scope><scope>8AO</scope><scope>8FE</scope><scope>8FH</scope><scope>8FI</scope><scope>8FJ</scope><scope>8FK</scope><scope>8G5</scope><scope>ABUWG</scope><scope>AFKRA</scope><scope>AZQEC</scope><scope>BBNVY</scope><scope>BEC</scope><scope>BENPR</scope><scope>BHPHI</scope><scope>C1K</scope><scope>CCPQU</scope><scope>DWQXO</scope><scope>FYUFA</scope><scope>GHDGH</scope><scope>GNUQQ</scope><scope>GUQSH</scope><scope>HCIFZ</scope><scope>K9.</scope><scope>KB0</scope><scope>LK8</scope><scope>M0S</scope><scope>M2O</scope><scope>M2P</scope><scope>M7P</scope><scope>MBDVC</scope><scope>NAPCQ</scope><scope>PQEST</scope><scope>PQQKQ</scope><scope>PQUKI</scope><scope>PRINS</scope><scope>Q9U</scope><scope>S0X</scope><scope>7X8</scope></search><sort><creationdate>20150301</creationdate><title>A Trial Activation Initiative to Accelerate Trial Opening in an Academic Medical Center</title><author>Choi, Yun Jung ; 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The Asan Medical Center, in Seoul, Korea, implemented a trial activation initiative in July 2012, in an aim to expedite the trial initiation timeline. Time intervals between trial initiation steps and the rate of institutional review board (IRB) and clinical trial agreement (CTA) parallel submission were assessed. A higher rate of parallel IRB and CTA submissions was observed after initiative implementation (25.5% vs 52.3%; P < .001). Initiative applications were shown to significantly accelerate the median trial opening time, from 114 to 81 days (P < .001). Strategic processing of parallel submissions greatly shortened the median time required for trial initiation from 117 to 61 days compared with sequential submissions (P < .001). A trial activation initiative including parallel IRB and CTA submissions is an effective tool for accelerating trial commencements.</abstract><cop>Los Angeles, CA</cop><pub>SAGE Publications</pub><pmid>30222419</pmid><doi>10.1177/2168479014554399</doi><tpages>5</tpages></addata></record> |
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| ispartof | Therapeutic innovation & regulatory science, 2015-03, Vol.49 (2), p.234-238 |
| issn | 2168-4790 2168-4804 |
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| source | SpringerLink Journals; SAGE Complete; Alma/SFX Local Collection |
| subjects | Accreditation Clinical Trials Contract negotiations Corporate sponsorship Drug Safety and Pharmacovigilance Pharmaceutical industry Pharmacotherapy Pharmacy Studies |
| title | A Trial Activation Initiative to Accelerate Trial Opening in an Academic Medical Center |
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