{"title":"新冠肺炎时代的临床开发与试验运营。","authors":"Seong Choon Choe","doi":"10.12793/tcp.2021.29.e23","DOIUrl":null,"url":null,"abstract":"Coronavirus disease 2019 (COVID-19) pandemic affects worldwide and various aspects of human life, including drug developments and clinical trials. Especially in trial operations, there are significant impacts from 2020 to 2021. According to the Arkivum report [1], ‘TMF futures 2021: good data within the age of digital transformation,’ 41% of latest clinical trials in 2020 were delayed or placed on hold indefinitely because of the COVID-19 pandemic, 41% of those delayed trials will now be run in 2021, 65% of the life sciences sector say they will still run clinical trials remotely after the pandemic, 57% of the sciences organizations say the price of running a trial has increased since the pandemic began and 49% of the sciences organizations say the time to finish a clinical trial has increased since the pandemic started. We need to review the trends and possible changes during and after the COVID-19 pandemic reviewing the various reports from biopharmaceutical consulting companies and contract research organizations (CROs).","PeriodicalId":23288,"journal":{"name":"Translational and Clinical Pharmacology","volume":"29 4","pages":"181-185"},"PeriodicalIF":1.1000,"publicationDate":"2021-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://ftp.ncbi.nlm.nih.gov/pub/pmc/oa_pdf/77/e3/tcp-29-181.PMC8718356.pdf","citationCount":"1","resultStr":"{\"title\":\"Clinical development and trial operations in COVID-19 era.\",\"authors\":\"Seong Choon Choe\",\"doi\":\"10.12793/tcp.2021.29.e23\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"Coronavirus disease 2019 (COVID-19) pandemic affects worldwide and various aspects of human life, including drug developments and clinical trials. Especially in trial operations, there are significant impacts from 2020 to 2021. According to the Arkivum report [1], ‘TMF futures 2021: good data within the age of digital transformation,’ 41% of latest clinical trials in 2020 were delayed or placed on hold indefinitely because of the COVID-19 pandemic, 41% of those delayed trials will now be run in 2021, 65% of the life sciences sector say they will still run clinical trials remotely after the pandemic, 57% of the sciences organizations say the price of running a trial has increased since the pandemic began and 49% of the sciences organizations say the time to finish a clinical trial has increased since the pandemic started. We need to review the trends and possible changes during and after the COVID-19 pandemic reviewing the various reports from biopharmaceutical consulting companies and contract research organizations (CROs).\",\"PeriodicalId\":23288,\"journal\":{\"name\":\"Translational and Clinical Pharmacology\",\"volume\":\"29 4\",\"pages\":\"181-185\"},\"PeriodicalIF\":1.1000,\"publicationDate\":\"2021-12-01\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"https://ftp.ncbi.nlm.nih.gov/pub/pmc/oa_pdf/77/e3/tcp-29-181.PMC8718356.pdf\",\"citationCount\":\"1\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Translational and Clinical Pharmacology\",\"FirstCategoryId\":\"1085\",\"ListUrlMain\":\"https://doi.org/10.12793/tcp.2021.29.e23\",\"RegionNum\":0,\"RegionCategory\":null,\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"2021/12/21 0:00:00\",\"PubModel\":\"Epub\",\"JCR\":\"Q4\",\"JCRName\":\"PHARMACOLOGY & PHARMACY\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Translational and Clinical Pharmacology","FirstCategoryId":"1085","ListUrlMain":"https://doi.org/10.12793/tcp.2021.29.e23","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"2021/12/21 0:00:00","PubModel":"Epub","JCR":"Q4","JCRName":"PHARMACOLOGY & PHARMACY","Score":null,"Total":0}
Clinical development and trial operations in COVID-19 era.
Coronavirus disease 2019 (COVID-19) pandemic affects worldwide and various aspects of human life, including drug developments and clinical trials. Especially in trial operations, there are significant impacts from 2020 to 2021. According to the Arkivum report [1], ‘TMF futures 2021: good data within the age of digital transformation,’ 41% of latest clinical trials in 2020 were delayed or placed on hold indefinitely because of the COVID-19 pandemic, 41% of those delayed trials will now be run in 2021, 65% of the life sciences sector say they will still run clinical trials remotely after the pandemic, 57% of the sciences organizations say the price of running a trial has increased since the pandemic began and 49% of the sciences organizations say the time to finish a clinical trial has increased since the pandemic started. We need to review the trends and possible changes during and after the COVID-19 pandemic reviewing the various reports from biopharmaceutical consulting companies and contract research organizations (CROs).
期刊介绍:
Translational and Clinical Pharmacology (Transl Clin Pharmacol, TCP) is the official journal of the Korean Society for Clinical Pharmacology and Therapeutics (KSCPT). TCP is an interdisciplinary journal devoted to the dissemination of knowledge relating to all aspects of translational and clinical pharmacology. The categories for publication include pharmacokinetics (PK) and drug disposition, drug metabolism, pharmacodynamics (PD), clinical trials and design issues, pharmacogenomics and pharmacogenetics, pharmacometrics, pharmacoepidemiology, pharmacovigilence, and human pharmacology. Studies involving animal models, pharmacological characterization, and clinical trials are appropriate for consideration.