{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,8,17]],"date-time":"2026-08-17T16:57:59Z","timestamp":1786985879840,"version":"build-2736575974"},"reference-count":35,"publisher":"Elsevier BV","license":[{"start":{"date-parts":[[2021,3,1]],"date-time":"2021-03-01T00:00:00Z","timestamp":1614556800000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/www.elsevier.com\/tdm\/userlicense\/1.0\/"},{"start":{"date-parts":[[2021,3,1]],"date-time":"2021-03-01T00:00:00Z","timestamp":1614556800000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/www.elsevier.com\/legal\/tdmrep-license"},{"start":{"date-parts":[[2021,3,1]],"date-time":"2021-03-01T00:00:00Z","timestamp":1614556800000},"content-version":"stm-asf","delay-in-days":0,"URL":"https:\/\/doi.org\/10.15223\/policy-017"},{"start":{"date-parts":[[2021,3,1]],"date-time":"2021-03-01T00:00:00Z","timestamp":1614556800000},"content-version":"stm-asf","delay-in-days":0,"URL":"https:\/\/doi.org\/10.15223\/policy-037"},{"start":{"date-parts":[[2021,3,1]],"date-time":"2021-03-01T00:00:00Z","timestamp":1614556800000},"content-version":"stm-asf","delay-in-days":0,"URL":"https:\/\/doi.org\/10.15223\/policy-012"},{"start":{"date-parts":[[2021,3,1]],"date-time":"2021-03-01T00:00:00Z","timestamp":1614556800000},"content-version":"stm-asf","delay-in-days":0,"URL":"https:\/\/doi.org\/10.15223\/policy-029"},{"start":{"date-parts":[[2021,3,1]],"date-time":"2021-03-01T00:00:00Z","timestamp":1614556800000},"content-version":"stm-asf","delay-in-days":0,"URL":"https:\/\/doi.org\/10.15223\/policy-004"}],"content-domain":{"domain":["clinicalkey.com","clinicalkey.com.au","clinicalkey.es","clinicalkey.fr","clinicalkey.jp","elsevier.com","sciencedirect.com"],"crossmark-restriction":true},"short-container-title":["Contemporary Clinical Trials"],"published-print":{"date-parts":[[2021,3]]},"DOI":"10.1016\/j.cct.2021.106292","type":"journal-article","created":{"date-parts":[[2021,1,27]],"date-time":"2021-01-27T11:50:31Z","timestamp":1611748231000},"page":"106292","update-policy":"https:\/\/doi.org\/10.1016\/elsevier_cm_policy","source":"Crossref","is-referenced-by-count":2,"special_numbering":"C","title":["Clinical trial preparations for the next pandemic"],"prefix":"10.1016","volume":"102","author":[{"given":"Jay","family":"Herson","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"78","reference":[{"issue":"22","key":"10.1016\/j.cct.2021.106292_bb0005","first-page":"1616","article-title":"The comparative effects of tissue plasminogen activator, streptokinase or both on coronary artery patency, ventricular function and survival after myocardial infarction","volume":"329","author":"GUSTO Angiographic Investigators","year":"1993","journal-title":"N. Engl. J. Med."},{"issue":"9645","key":"10.1016\/j.cct.2021.106292_bb0010","doi-asserted-by":"crossref","first-page":"1223","DOI":"10.1016\/S0140-6736(08)61239-8","article-title":"Effect of n-3 polyunsaturated fatty acids in patients with chronic heart failure GISSI-HF: a randomized double-blind, placebo-controlled trial","volume":"372","author":"Tavazzi","year":"2008","journal-title":"Lancet"},{"key":"10.1016\/j.cct.2021.106292_bb0015","author":"University of Oxford"},{"key":"10.1016\/j.cct.2021.106292_bb0020","author":"University of Oxford"},{"issue":"1","key":"10.1016\/j.cct.2021.106292_bb0025","doi-asserted-by":"crossref","first-page":"62","DOI":"10.1056\/NEJMra1510062","article-title":"Master protocols to study multiple therapies, multiple diseases or both","volume":"377","author":"Woodcock","year":"2017","journal-title":"N. Engl. J. Med."},{"key":"10.1016\/j.cct.2021.106292_bb0030","author":"World Health Organization"},{"key":"10.1016\/j.cct.2021.106292_bb0035","doi-asserted-by":"crossref","first-page":"1","DOI":"10.1186\/s13063-019-3906-2","volume":"21","author":"Griffiths","year":"2020","journal-title":"Trials"},{"issue":"4","key":"10.1016\/j.cct.2021.106292_bb0040","doi-asserted-by":"crossref","first-page":"483","DOI":"10.1080\/19466315.2020.1790415","article-title":"Efficient adaptive designs for clinical trials of interventions for COVID-19","volume":"12","author":"Stallard","year":"2020","journal-title":"Stat. Biopharm. Res."},{"key":"10.1016\/j.cct.2021.106292_bb0045","series-title":"Data and Safety Monitoring Committees in Clinical Trials","author":"Herson","year":"2017"},{"issue":"19","key":"10.1016\/j.cct.2021.106292_bb0050","doi-asserted-by":"crossref","first-page":"1813","DOI":"10.1056\/NEJMoa2007764","article-title":"Remdesivir for the treatment of COVID-19\u2014final report","volume":"383","author":"Beigel","year":"2020","journal-title":"N. Engl. J. Med."},{"key":"10.1016\/j.cct.2021.106292_bb0055","article-title":"SARS-Cov-2 neutralizing antibody LY-CoV555 in outpatients with Covid-19","author":"Chen","year":"2020","journal-title":"N. Engl. J. Med."},{"issue":"13","key":"10.1016\/j.cct.2021.106292_bb0060","doi-asserted-by":"crossref","first-page":"1307","DOI":"10.1001\/jama.2020.17021","article-title":"Effect of dexamethasone on days alive and ventilator-free in patients with moderate or severe acute respiratory distress syndrome and COVID-19: the CoDEX randomized clinical trial","volume":"324","author":"Tomazini","year":"2020","journal-title":"JAMA"},{"key":"10.1016\/j.cct.2021.106292_bb0065","series-title":"Chapter 22: Prospective Approaches to Accumulating Evidence","author":"Thomas","year":"2020"},{"issue":"13","key":"10.1016\/j.cct.2021.106292_bb0070","doi-asserted-by":"crossref","first-page":"1330","DOI":"10.1001\/jama.2020.17023","article-title":"Association between administration of systemic corticosteroids and mortality among critically ill patients with COVID-19","volume":"324","author":"World Health Organization REACT Working Group","year":"2020","journal-title":"JAMA"},{"key":"10.1016\/j.cct.2021.106292_bb0075","doi-asserted-by":"crossref","first-page":"38","DOI":"10.1016\/j.jclinepi.2017.08.008","article-title":"Statistical methods for updating meta-analysis","volume":"91","author":"Simmonds","year":"2017","journal-title":"J. Clin. Epidemiol."},{"key":"10.1016\/j.cct.2021.106292_bb0080","author":"World Health Organization"},{"key":"10.1016\/j.cct.2021.106292_bb0085","author":"Food and Drug Administration"},{"key":"10.1016\/j.cct.2021.106292_bb0090","author":"European Medicines Agency"},{"issue":"1","key":"10.1016\/j.cct.2021.106292_bb0095","doi-asserted-by":"crossref","first-page":"215","DOI":"10.1111\/biom.12384","article-title":"On the restricted mean survival time curve in survival analysis","volume":"72","author":"Zhao","year":"2016","journal-title":"Biometrics"},{"key":"10.1016\/j.cct.2021.106292_bb0100","series-title":"Personal Communication","author":"Hu","year":"2020"},{"issue":"8","key":"10.1016\/j.cct.2021.106292_bb0105","doi-asserted-by":"crossref","first-page":"632","DOI":"10.7326\/M20-4044","article-title":"How to quantify and interpret treatment effects in comparative clinical studies of COVID-19","volume":"173","author":"McCaw","year":"2020","journal-title":"Ann. Intern. Med."},{"issue":"5","key":"10.1016\/j.cct.2021.106292_bb0110","doi-asserted-by":"crossref","first-page":"460","DOI":"10.1001\/jama.2020.10044","article-title":"Effect of convalescent plasma therapy on time to clinical improvement in patients with severe and life threatening COVID-19: a randomized clinical trial","volume":"324","author":"Li","year":"2020","journal-title":"JAMA"},{"issue":"4","key":"10.1016\/j.cct.2021.106292_bb0115","doi-asserted-by":"crossref","first-page":"1171","DOI":"10.2307\/2532457","article-title":"Assessing proportionality in the proportional odds model for ordinal logistic regression","volume":"46","author":"Brant","year":"1990","journal-title":"Biometrics"},{"key":"10.1016\/j.cct.2021.106292_bb0120","doi-asserted-by":"crossref","DOI":"10.1080\/19466315.2020.1779122","article-title":"Statistical issues and recommendations for clinical trials conducted during the COVID-19 pandemic","author":"Meyer","year":"2020","journal-title":"Statist. Biopharm. Res."},{"key":"10.1016\/j.cct.2021.106292_bb0125","author":"Qu"},{"issue":"2","key":"10.1016\/j.cct.2021.106292_bb0130","doi-asserted-by":"crossref","first-page":"324","DOI":"10.1007\/s43441-019-00061-x","article-title":"Choosing estimands in clinical trials: putting the ICH E9(R1) into practice","volume":"54","author":"Ratitch","year":"2020","journal-title":"Ther. Innov. Regulat. Sci."},{"key":"10.1016\/j.cct.2021.106292_bb0135","author":"Makowski"},{"key":"10.1016\/j.cct.2021.106292_bb0140","author":"Food and Drug Administration"},{"key":"10.1016\/j.cct.2021.106292_bb0145","author":"Perevozskaya"},{"key":"10.1016\/j.cct.2021.106292_bb0150","doi-asserted-by":"crossref","first-page":"1569","DOI":"10.1016\/S0140-6736(20)31022-9","article-title":"Remdesivir in adults with severe COVID-19: a randomized double-blind, placebo-controlled multicentre trial","volume":"395","author":"Wang","year":"2020","journal-title":"Lancet"},{"key":"10.1016\/j.cct.2021.106292_bb0155","author":"Food and Drug Administration"},{"issue":"6","key":"10.1016\/j.cct.2021.106292_bb0160","doi-asserted-by":"crossref","first-page":"705","DOI":"10.1177\/1740774512447898","article-title":"A statistical approach to central monitoring of data quality in clinical trials","volume":"9","author":"Venet","year":"2012","journal-title":"Clin. Trials"},{"issue":"30","key":"10.1016\/j.cct.2021.106292_bb0165","doi-asserted-by":"crossref","first-page":"5265","DOI":"10.1002\/sim.6294","article-title":"Linear mixed-effects models for central statistical monitoring of multicenter clinical trials","volume":"33","author":"Desmet","year":"2014","journal-title":"Stat. Med."},{"issue":"6","key":"10.1016\/j.cct.2021.106292_bb0170","doi-asserted-by":"crossref","first-page":"517","DOI":"10.1056\/NEJMoa2016638","article-title":"A randomized trial of hydroxychloroquine as post-exposure prophylaxis for COVID-19","volume":"383","author":"Boulware","year":"2020","journal-title":"N. Engl. J. Med."},{"key":"10.1016\/j.cct.2021.106292_bb0175","doi-asserted-by":"crossref","DOI":"10.1136\/bmj.h2147","article-title":"The PRECIS-2 tool: designing trials that are fit for purpose","volume":"350","author":"Loudon","year":"2015","journal-title":"BMJ"}],"container-title":["Contemporary Clinical Trials"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/api.elsevier.com\/content\/article\/PII:S1551714421000288?httpAccept=text\/xml","content-type":"text\/xml","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/api.elsevier.com\/content\/article\/PII:S1551714421000288?httpAccept=text\/plain","content-type":"text\/plain","content-version":"vor","intended-application":"text-mining"}],"deposited":{"date-parts":[[2025,10,27]],"date-time":"2025-10-27T08:50:41Z","timestamp":1761555041000},"score":1,"resource":{"primary":{"URL":"https:\/\/linkinghub.elsevier.com\/retrieve\/pii\/S1551714421000288"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2021,3]]},"references-count":35,"alternative-id":["S1551714421000288"],"URL":"https:\/\/doi.org\/10.1016\/j.cct.2021.106292","relation":{},"ISSN":["1551-7144"],"issn-type":[{"value":"1551-7144","type":"print"}],"subject":[],"published":{"date-parts":[[2021,3]]},"assertion":[{"value":"Elsevier","name":"publisher","label":"This article is maintained by"},{"value":"Clinical trial preparations for the next pandemic","name":"articletitle","label":"Article Title"},{"value":"Contemporary Clinical Trials","name":"journaltitle","label":"Journal Title"},{"value":"https:\/\/doi.org\/10.1016\/j.cct.2021.106292","name":"articlelink","label":"CrossRef DOI link to publisher maintained version"},{"value":"article","name":"content_type","label":"Content Type"},{"value":"\u00a9 2021 Elsevier Inc. All rights reserved.","name":"copyright","label":"Copyright"}],"article-number":"106292"}}