{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2025,10,29]],"date-time":"2025-10-29T13:16:46Z","timestamp":1761743806687,"version":"build-2065373602"},"reference-count":46,"publisher":"Elsevier BV","license":[{"start":{"date-parts":[[2022,11,1]],"date-time":"2022-11-01T00:00:00Z","timestamp":1667260800000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/www.elsevier.com\/tdm\/userlicense\/1.0\/"},{"start":{"date-parts":[[2022,11,1]],"date-time":"2022-11-01T00:00:00Z","timestamp":1667260800000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/www.elsevier.com\/legal\/tdmrep-license"},{"start":{"date-parts":[[2022,8,31]],"date-time":"2022-08-31T00:00:00Z","timestamp":1661904000000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"funder":[{"DOI":"10.13039\/501100001711","name":"Schweizerischer Nationalfonds zur F\u00f6rderung der Wissenschaftlichen Forschung","doi-asserted-by":"publisher","award":["31CA30_196190"],"award-info":[{"award-number":["31CA30_196190"]}],"id":[{"id":"10.13039\/501100001711","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["zefq-journal.com","elsevier.com","sciencedirect.com"],"crossmark-restriction":true},"short-container-title":["Zeitschrift f\u00fcr Evidenz, Fortbildung und Qualit\u00e4t im Gesundheitswesen"],"published-print":{"date-parts":[[2022,11]]},"DOI":"10.1016\/j.zefq.2022.08.003","type":"journal-article","created":{"date-parts":[[2022,9,28]],"date-time":"2022-09-28T01:32:09Z","timestamp":1664328729000},"page":"32-42","update-policy":"https:\/\/doi.org\/10.1016\/elsevier_cm_policy","source":"Crossref","is-referenced-by-count":0,"special_numbering":"C","title":["Clinical trial research agenda on COVID-19 \u2013 the first two years in Germany and beyond"],"prefix":"10.1016","volume":"174","author":[{"ORCID":"https:\/\/orcid.org\/0000-0001-6589-3936","authenticated-orcid":false,"given":"Julian","family":"Hirt","sequence":"first","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-7684-8014","authenticated-orcid":false,"given":"Perrine","family":"Janiaud","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-3444-1432","authenticated-orcid":false,"given":"Lars G.","family":"Hemkens","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"78","reference":[{"key":"10.1016\/j.zefq.2022.08.003_b0005","article-title":"Massive covidization of research citations and the citation elite","author":"Ioannidis","year":"2022","journal-title":"medRxiv"},{"key":"10.1016\/j.zefq.2022.08.003_b0010","doi-asserted-by":"crossref","first-page":"28","DOI":"10.1038\/s41541-021-00292-w","article-title":"SARS-CoV-2 vaccines strategies: a comprehensive review of phase 3 candidates","volume":"6","author":"Kyriakidis","year":"2021","journal-title":"npj Vaccines"},{"key":"10.1016\/j.zefq.2022.08.003_b0015","doi-asserted-by":"crossref","DOI":"10.1371\/journal.pmed.1002049","article-title":"Why Most Clinical Research Is Not Useful","volume":"13","author":"Ioannidis","year":"2016","journal-title":"PLoS Med"},{"key":"10.1016\/j.zefq.2022.08.003_b0020","article-title":"Randomised trials on non-pharmaceutical interventions for COVID-19 as of August 2021: a scoping review","author":"Hirt","year":"2022","journal-title":"BMJ EBM"},{"key":"10.1016\/j.zefq.2022.08.003_b0025","doi-asserted-by":"crossref","first-page":"1193","DOI":"10.12688\/f1000research.26707.2","article-title":"The worldwide clinical trial research response to the COVID-19 pandemic - the first 100 days [version 2; peer review: 2 approved]","volume":"9","author":"Janiaud","year":"2020","journal-title":"F1000Res"},{"key":"10.1016\/j.zefq.2022.08.003_b0030","first-page":"1353","article-title":"Challenges and lessons learned from Covid-19 trials \u2013 should we be doing clinical trials differently?","volume":"37","author":"Janiaud","year":"2021","journal-title":"Can J Cardiol"},{"key":"10.1016\/j.zefq.2022.08.003_b0035","doi-asserted-by":"crossref","first-page":"913","DOI":"10.12688\/f1000research.55541.1","article-title":"Clinical trial research on COVID-19 in Germany \u2013 a systematic analysis [version 1; peer review: awaiting peer review]","volume":"10","author":"Hirt","year":"2021","journal-title":"F1000Res"},{"key":"10.1016\/j.zefq.2022.08.003_b0040","unstructured":"J. Hirt, P. Janiaud, L.G. Hemkens, Why we urgently need a long-term research agenda on non-pharmaceutical interventions to guide policies and practices in the current and future public health emergencies: Blog entry written on: Randomized trials on non-pharmaceutical interventions for COVID-19: a scoping review, (bmjebm-2021-111825), 2022. https:\/\/blogs.bmj.com\/bmjebmspotlight\/2022\/03\/25\/why-we-urgently-need-a-long-term-research-agenda-on-non-pharmaceutical-interventions-to-guide-policies-and-practices-in-the-current-and-future-public-health-emergencies\/ (accessed 25 April 2022)."},{"key":"10.1016\/j.zefq.2022.08.003_b0045","doi-asserted-by":"crossref","unstructured":"J. Hirt, P. Janiaud, P. D\u00fcblin, L.G. Hemkens, Randomized trials assessing non-pharmaceutical interventions to prevent COVID-19: A living systematic overview on randomized trials assessing non-pharmaceutical interventions to prevent COVID-19, 2021. https:\/\/osf.io\/fq9jh\/.","DOI":"10.1136\/bmjebm-2021-111825"},{"key":"10.1016\/j.zefq.2022.08.003_b0050","unstructured":"P. Janiaud, C. Axfors, R. Saccilotto, A.M. Schmitt, J. Hirt, L.G. Hemkens, COVID-evidence: a living database of trials on interventions for COVID-19, 2021. https:\/\/osf.io\/gehfx\/ (accessed 2 November 2021)."},{"key":"10.1016\/j.zefq.2022.08.003_b0055","unstructured":"COVID-NMA, The COVID-NMA initiative: A living mapping and living systematic review of Covid-19 trials. https:\/\/covid-nma.com\/ (accessed 13 July 2022)."},{"key":"10.1016\/j.zefq.2022.08.003_b0060","doi-asserted-by":"crossref","unstructured":"M. Salholz-Hillel, P. Grabitz, M. Pugh-Jones, D. Strech, N.J. DeVito, Results Availability and Timeliness of Registered COVID-19 Clinical Trials: A Cross-Sectional Study: Preprint (2021). https:\/\/doi.org\/10.1101\/2021.04.07.21255071.","DOI":"10.1101\/2021.04.07.21255071"},{"key":"10.1016\/j.zefq.2022.08.003_b0065","unstructured":"COVID-evidence, COVID-evidence Database: Living overview on randomized trials assessing non-pharmaceutical interventions to prevent COVID-19, 2022. https:\/\/covid-evidence.org\/database?page=npi (accessed 28 February 2022)."},{"key":"10.1016\/j.zefq.2022.08.003_b0070","doi-asserted-by":"crossref","first-page":"46","DOI":"10.1016\/j.jclinepi.2021.09.022","article-title":"Secondary electronic sources demonstrated very good sensitivity for identifying studies evaluating interventions for COVID-19","volume":"141","author":"Pierre","year":"2022","journal-title":"J Clin Epidemiol"},{"key":"10.1016\/j.zefq.2022.08.003_b0075","unstructured":"REMAP-CAP, REMAP-CAP: A Randomised, Embedded, Multi-factorial, Adaptive Platform Trial for Community-Acquired Pneumonia, 2022. https:\/\/www.remapcap.org\/ (accessed 17 March 2021)."},{"key":"10.1016\/j.zefq.2022.08.003_b0080","unstructured":"University of Oxford, RECOVERY Trial, 2022. https:\/\/www.recoverytrial.net\/ (accessed 17 March 2022)."},{"key":"10.1016\/j.zefq.2022.08.003_b0085","doi-asserted-by":"crossref","first-page":"2349","DOI":"10.1038\/s41467-021-22446-z","article-title":"Mortality outcomes with hydroxychloroquine and chloroquine in COVID-19 from an international collaborative meta-analysis of randomized trials","volume":"12","author":"Axfors","year":"2021","journal-title":"Nat Commun"},{"key":"10.1016\/j.zefq.2022.08.003_b0090","doi-asserted-by":"crossref","first-page":"499","DOI":"10.1016\/j.jclinepi.2009.01.012","article-title":"Explanatory and pragmatic attitudes in therapeutical trials","volume":"62","author":"Schwartz","year":"2009","journal-title":"J Clin Epidemiol"},{"key":"10.1016\/j.zefq.2022.08.003_b0095","doi-asserted-by":"crossref","first-page":"326","DOI":"10.1038\/d41586-020-02416-z","article-title":"How we accelerated clinical trials in the age of coronavirus","volume":"584","author":"Mather","year":"2020","journal-title":"Nature"},{"key":"10.1016\/j.zefq.2022.08.003_b0100","unstructured":"University of Oxford, The RECOVERY Trial is two years old today, 2022. https:\/\/www.recoverytrial.net\/news\/the-recovery-trial-is-two-years-old-today (accessed 23 March 2022)."},{"key":"10.1016\/j.zefq.2022.08.003_b0105","doi-asserted-by":"crossref","first-page":"2349","DOI":"10.1093\/eurheartj\/ehx395","article-title":"Beyond the P-value and the sound bite: learning from 'negative' clinical trials","volume":"38","author":"Desai","year":"2017","journal-title":"Eur Heart J"},{"key":"10.1016\/j.zefq.2022.08.003_b0110","doi-asserted-by":"crossref","first-page":"790","DOI":"10.1016\/j.mayocp.2013.05.012","article-title":"A decade of reversal: an analysis of 146 contradicted medical practices","volume":"88","author":"Prasad","year":"2013","journal-title":"Mayo Clinic Proc"},{"key":"10.1016\/j.zefq.2022.08.003_b0115","unstructured":"M.J. Joyner, J.W. Senefeld, S.A. Klassen, J.R. Mills, P.W. Johnson, E.S. Theel, C.C. Wiggins, K.A. Bruno, A.M. Klompas, E.R. Lesser, K.L. Kunze, M.A. Sexton, J.C. Diaz Soto, S.E. Baker, J.R.A. Shepherd, N. van Helmond, C.M. van Buskirk, J.L. Winters, J.R. Stubbs, R.F. Rea, D.O. Hodge, V. Herasevich, E.R. Whelan, A.J. Clayburn, K.F. Larson, J.G. Ripoll, K.J. Andersen, M.R. Buras, M.N.P. Vogt, J.J. Dennis, R.J. Regimbal, P.R. Bauer, J.E. Blair, N.S. Paneth, D. Fairweather, R.S. Wright, R.E. Carter, A. Casadevall, Effect of Convalescent Plasma on Mortality among Hospitalized Patients with COVID-19: Initial Three-Month Experience, 2020"},{"key":"10.1016\/j.zefq.2022.08.003_b0120","article-title":"RETRACTED: Hydroxychloroquine or chloroquine with or without a macrolide for treatment of COVID-19: a multinational registry analysis","author":"Mehra","year":"2020","journal-title":"The Lancet"},{"key":"10.1016\/j.zefq.2022.08.003_b0125","doi-asserted-by":"crossref","first-page":"e243","DOI":"10.7861\/fhj.2021-0083","article-title":"Making trials part of good clinical care: lessons from the RECOVERY trial","volume":"8","author":"Pessoa-Amorim","year":"2021","journal-title":"Future Healthc J"},{"key":"10.1016\/j.zefq.2022.08.003_b0130","unstructured":"[26] RECOVERY Central Coordinating Office, Randomised evaluation of COVID-19 Therapy (RECOVERY), 2022. https:\/\/www.recoverytrial.net\/files\/recovery-protocol-v23-1-2022-03-15.pdf (accessed 1 April 2022)."},{"key":"10.1016\/j.zefq.2022.08.003_b0135","doi-asserted-by":"crossref","first-page":"1572","DOI":"10.1056\/NEJMc2102446","article-title":"Platform Trials - Beware the Noncomparable Control Group","volume":"384","author":"Dodd","year":"2021","journal-title":"N Engl J Med"},{"key":"10.1016\/j.zefq.2022.08.003_b0140","first-page":"756","article-title":"F\u00f6deralismus spaltet die Gesellschaft","volume":"118","author":"Maybaum","year":"2021","journal-title":"Deutsches \u00c4rzteblatt"},{"key":"10.1016\/j.zefq.2022.08.003_b0145","unstructured":"Frankfurter Rundschau, Masken, Tests, Distanzunterricht: Diese Corona-Regeln gelten jetzt an Schulen in Deutschland, 2022. https:\/\/www.fr.de\/panorama\/corona-regeln-schulen-bundeslaender-masken-tests-unterricht-distanz-homescooling-mai-aenderungen-news-91511261.html (accessed 14 June 2022)."},{"key":"10.1016\/j.zefq.2022.08.003_b0150","doi-asserted-by":"crossref","first-page":"40","DOI":"10.1038\/nbt.2786","article-title":"Clinical development success rates for investigational drugs","volume":"32","author":"Hay","year":"2014","journal-title":"Nat Biotechnol"},{"key":"10.1016\/j.zefq.2022.08.003_b0155","article-title":"A living overview of randomized trials on non-pharmaceutical interventions for COVID-19: Vortrag","author":"Hirt","year":"2022","journal-title":"Online-Pre-Conference EbM-Kongress"},{"key":"10.1016\/j.zefq.2022.08.003_b0160","doi-asserted-by":"crossref","first-page":"1622","DOI":"10.1038\/s41591-021-01487-3","article-title":"Effects of a large-scale social media advertising campaign on holiday travel and COVID-19 infections: a cluster randomized controlled trial","volume":"27","author":"Breza","year":"2021","journal-title":"Nat Med"},{"key":"10.1016\/j.zefq.2022.08.003_b0165","article-title":"The GLasses Against transmission of SARS-CoV-2 in the communitY (GLASSY) trial: A pragmatic randomized trial (study protocol)","author":"Fretheim","year":"2022","journal-title":"medRxiv"},{"key":"10.1016\/j.zefq.2022.08.003_b0170","article-title":"Cash transfer during the COVID-19 pandemic: a multicentre, randomised controlled trial","volume":"9","author":"Persaud","year":"2021","journal-title":"Fam Med Community Health"},{"key":"10.1016\/j.zefq.2022.08.003_b0175","article-title":"Waste in covid-19 research","volume":"369","author":"Glasziou","year":"2020","journal-title":"BMJ"},{"key":"10.1016\/j.zefq.2022.08.003_b0180","article-title":"Traurige Forschungskultur und fehlender politischer Wille, Observer","author":"Windeler","year":"2021","journal-title":"Gesundheit"},{"key":"10.1016\/j.zefq.2022.08.003_b0185","doi-asserted-by":"crossref","DOI":"10.1371\/journal.pone.0059213","article-title":"All nations depend on the global knowledge pool \u2013 analysis of country of origin of studies used for health technology assessments in Germany","volume":"8","author":"Herrmann","year":"2013","journal-title":"PLoS ONE"},{"key":"10.1016\/j.zefq.2022.08.003_b0190","unstructured":"ClinicalTrials.gov, Longitudinal COVID-19 Antibody Testing in Indiana University Undergraduate Students: Study Results, 2022. https:\/\/clinicaltrials.gov\/ct2\/show\/results\/NCT04620798?view=results (accessed 24 March 2022)."},{"key":"10.1016\/j.zefq.2022.08.003_b0195","doi-asserted-by":"crossref","DOI":"10.14309\/ctg.0000000000000314","article-title":"Negative-Pressure Isolation Mask for Endoscopic Examination During the Coronavirus Disease 2019 Pandemic: A Randomized Controlled Trial","volume":"12","author":"Gao","year":"2021","journal-title":"Clin Transl Gastroenterol"},{"key":"10.1016\/j.zefq.2022.08.003_b0200","doi-asserted-by":"crossref","first-page":"335","DOI":"10.7326\/M20-6817","article-title":"Effectiveness of Adding a Mask Recommendation to Other Public Health Measures to Prevent SARS-CoV-2 Infection in Danish Mask Wearers A Randomized Controlled Trial","volume":"174","author":"Bundgaard","year":"2021","journal-title":"Ann Intern Med"},{"key":"10.1016\/j.zefq.2022.08.003_b0205","article-title":"A Randomised Trial of Covid-19 Transmission in Training Facilities","author":"Helsingen","year":"2022","journal-title":"medRxiv"},{"key":"10.1016\/j.zefq.2022.08.003_b0210","article-title":"Efficacy of Pranayama in Preventing COVID-19 in Exposed Healthcare Professionals: A Randomized Controlled Trial","author":"Sarwal","year":"2021","journal-title":"OSF"},{"key":"10.1016\/j.zefq.2022.08.003_b0215","doi-asserted-by":"crossref","first-page":"1365","DOI":"10.1016\/S1473-3099(21)00268-1","article-title":"Same-day SARS-CoV-2 antigen test screening in an indoor mass-gathering live music event: a randomised controlled trial","volume":"21","author":"Revollo","year":"2021","journal-title":"Lancet Infect Dis"},{"key":"10.1016\/j.zefq.2022.08.003_b0220","doi-asserted-by":"crossref","first-page":"1217","DOI":"10.1016\/S0140-6736(21)01908-5","article-title":"Daily testing for contacts of individuals with SARS-CoV-2 infection and attendance and SARS-CoV-2 transmission in English secondary schools and colleges: an open-label, cluster-randomised trial","volume":"398","author":"Young","year":"2021","journal-title":"The Lancet"},{"key":"10.1016\/j.zefq.2022.08.003_b0225","doi-asserted-by":"crossref","first-page":"eabi9069","DOI":"10.1126\/science.abi9069","article-title":"Impact of community masking on COVID-19: A cluster-randomized trial in Bangladesh","author":"Abaluck","year":"2022","journal-title":"Science 375"},{"key":"10.1016\/j.zefq.2022.08.003_b0230","doi-asserted-by":"crossref","first-page":"341","DOI":"10.1016\/S1473-3099(21)00673-3","article-title":"Prevention of SARS-CoV-2 transmission during a large, live, indoor gathering (SPRING): a non-inferiority, randomised, controlled trial","volume":"22","author":"Delaugerre","year":"2022","journal-title":"Lancet Infectious Diseases"}],"container-title":["Zeitschrift f\u00fcr Evidenz, Fortbildung und Qualit\u00e4t im Gesundheitswesen"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/api.elsevier.com\/content\/article\/PII:S186592172200160X?httpAccept=text\/xml","content-type":"text\/xml","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/api.elsevier.com\/content\/article\/PII:S186592172200160X?httpAccept=text\/plain","content-type":"text\/plain","content-version":"vor","intended-application":"text-mining"}],"deposited":{"date-parts":[[2025,10,29]],"date-time":"2025-10-29T08:02:18Z","timestamp":1761724938000},"score":1,"resource":{"primary":{"URL":"https:\/\/linkinghub.elsevier.com\/retrieve\/pii\/S186592172200160X"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2022,11]]},"references-count":46,"alternative-id":["S186592172200160X"],"URL":"https:\/\/doi.org\/10.1016\/j.zefq.2022.08.003","relation":{},"ISSN":["1865-9217"],"issn-type":[{"type":"print","value":"1865-9217"}],"subject":[],"published":{"date-parts":[[2022,11]]},"assertion":[{"value":"Elsevier","name":"publisher","label":"This article is maintained by"},{"value":"Clinical trial research agenda on COVID-19 \u2013 the first two years in Germany and beyond","name":"articletitle","label":"Article Title"},{"value":"Zeitschrift f\u00fcr Evidenz, Fortbildung und Qualit\u00e4t im Gesundheitswesen","name":"journaltitle","label":"Journal Title"},{"value":"https:\/\/doi.org\/10.1016\/j.zefq.2022.08.003","name":"articlelink","label":"CrossRef DOI link to publisher maintained version"},{"value":"article","name":"content_type","label":"Content Type"},{"value":"\u00a9 2022 Published by Elsevier GmbH.","name":"copyright","label":"Copyright"}]}}