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We explore this issue by looking at the positions of 3 major regulators: the European Medicines Agency, Food and Drug Administration, and Health Canada. Here we report their views and the implications of those views for the approval process. On various points, the 3 regulators are ambiguous, consistent, and demonstrate flexibility. The range of views may well reflect different regulatory cultures. Although clinical trial information from pivotal trials is becoming more available, regulators are still reluctant to provide detailed information about how that information is interpreted. As medicines and vaccines come up for approval for treatment of COVID-19, transparency in how pivotal trials are interpreted will be critical in determining how these treatments should be used.<\/jats:p>","DOI":"10.1177\/0020731420979824","type":"journal-article","created":{"date-parts":[[2020,12,22]],"date-time":"2020-12-22T00:32:07Z","timestamp":1608597127000},"page":"5-13","update-policy":"https:\/\/doi.org\/10.1177\/sage-journals-update-policy","source":"Crossref","is-referenced-by-count":19,"title":["Regulators, Pivotal Clinical Trials, and Drug Regulation in the Age of COVID-19"],"prefix":"10.1177","volume":"51","author":[{"ORCID":"https:\/\/orcid.org\/0000-0001-5120-8029","authenticated-orcid":false,"given":"Joel","family":"Lexchin","sequence":"first","affiliation":[{"name":"Faculty of Health, York University, Toronto, Ontario, Canada"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Janice","family":"Graham","sequence":"additional","affiliation":[{"name":"Faculty of Medicine, Dalhousie University, Halifax, Nova Scotia, Canada"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Matthew","family":"Herder","sequence":"additional","affiliation":[{"name":"Shulich School of Law, Health Law Institute, Halifax, Nova Scotia, Canada"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Tom","family":"Jefferson","sequence":"additional","affiliation":[{"name":"Department of Continuing Education, University of Oxford, Oxford, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Trudo","family":"Lemmens","sequence":"additional","affiliation":[{"name":"Faculty of Law Toronto, University of Toronto, Toronto, Ontario, Canada"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"179","published-online":{"date-parts":[[2020,12,21]]},"reference":[{"key":"bibr1-0020731420979824","unstructured":"Therapeutic Products Programme. Preparation of human new drug submissions. Health Canada. http:\/\/publications.gc.ca\/collections\/collection_2013\/sc-hc\/H42-2-38-1991-eng.pdf. Published 1991. Accessed April 29, 2020."},{"key":"bibr2-0020731420979824","doi-asserted-by":"publisher","DOI":"10.1001\/jama.2013.282034"},{"key":"bibr3-0020731420979824","unstructured":"Regulation (EC) no 726\/2004 of the European Parliament and of the Council laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency. Official Journal of the European Union Web site. https:\/\/eur-lex.europa.eu\/LexUriServ\/LexUriServ.do?uri=OJ:L:2004:136:0001:0033:en:PDF. Published 2004. Updated March 31. Accessed October 30, 2020."},{"key":"bibr4-0020731420979824","doi-asserted-by":"publisher","DOI":"10.1136\/bmjopen-2016-014582"},{"key":"bibr5-0020731420979824","volume-title":"WHO Regulatory Systems Strengthening Programme: WHO Role in Building Effective and Efficient Regulatory Systems for Health Products","author":"World Health Organization","year":"2019"},{"key":"bibr6-0020731420979824","doi-asserted-by":"publisher","DOI":"10.1002\/14651858.MR000033.pub3"},{"key":"bibr7-0020731420979824","unstructured":"Herper M. Inside the NIH\u2019s controversial decision to stop its big Remdesivir study. STAT. https:\/\/www.statnews.com\/2020\/05\/11\/inside-the-nihs-controversial-decision-to-stop-its-big-remdesivir-study\/. Published 2020. Updated May 11. Accessed May 18, 2020."},{"key":"bibr8-0020731420979824","doi-asserted-by":"crossref","unstructured":"Beigel J, Tomashek K, Dodd L, et\u00a0al. Remdesivir for the treatment of Covid-19\u2014preliminary report.\n                      N Engl J Med.\n                      2020;383:992\u2013994.","DOI":"10.1056\/NEJMc2022236"},{"key":"bibr9-0020731420979824","doi-asserted-by":"publisher","DOI":"10.1159\/000064813"},{"key":"bibr10-0020731420979824","doi-asserted-by":"publisher","DOI":"10.1001\/jamanetworkopen.2020.3284"},{"key":"bibr11-0020731420979824","doi-asserted-by":"publisher","DOI":"10.1111\/cts.12617"},{"key":"bibr12-0020731420979824","first-page":"2073","volume":"70","author":"Darrow J.","year":"2013","journal-title":"Wash Lee Leg Rev"},{"key":"bibr13-0020731420979824","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMsa065779"},{"key":"bibr14-0020731420979824","unstructured":"Food and Drug Regulations, consolidated, C.R.C., c. 870, \u00a7C.08.002(2)(h), 2014."},{"key":"bibr15-0020731420979824","doi-asserted-by":"publisher","DOI":"10.1136\/bmj.l1825"},{"key":"bibr16-0020731420979824","volume-title":"Regulating medicines in a globalized world: the need for increased reliance among regulators","author":"National Academies of Sciences, Engineering, and Medicine","year":"2020"},{"key":"bibr17-0020731420979824","volume-title":"Pharmacopolitics: drug regulation in the United States and Germany","author":"Daemmrich AA.","year":"2004"},{"key":"bibr18-0020731420979824","doi-asserted-by":"publisher","DOI":"10.1002\/hast.833"},{"key":"bibr19-0020731420979824","doi-asserted-by":"publisher","DOI":"10.9778\/cmajo.20190010"},{"key":"bibr20-0020731420979824","doi-asserted-by":"publisher","DOI":"10.1016\/j.socscimed.2009.09.002"},{"key":"bibr21-0020731420979824","doi-asserted-by":"publisher","DOI":"10.1093\/annonc\/mdt512"},{"key":"bibr22-0020731420979824","doi-asserted-by":"publisher","DOI":"10.1111\/1468-0009.12476"},{"key":"bibr23-0020731420979824","doi-asserted-by":"publisher","DOI":"10.7202\/045360ar"},{"key":"bibr24-0020731420979824","doi-asserted-by":"publisher","DOI":"10.1001\/jamanetworkopen.2020.9498"},{"key":"bibr25-0020731420979824","doi-asserted-by":"publisher","DOI":"10.1001\/jamainternmed.2020.0074"},{"key":"bibr26-0020731420979824","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMp2009457"},{"key":"bibr27-0020731420979824","author":"Lenzer J","year":"2020","journal-title":"Issues Sci Technol"},{"key":"bibr28-0020731420979824","unstructured":"Sagonowsky E. Unlike FDA, European regulators refuse to clear chloroquine for COVID-19 without data. https:\/\/www.fiercepharma.com\/pharma\/europe-locks-down-chloroquine-scripts-as-researchers-china-report-positive-controlled-covid. Published 2020. Updated April 2. Accessed May 18, 2020."},{"key":"bibr29-0020731420979824","doi-asserted-by":"publisher","DOI":"10.1093\/jlb\/lsaa083"},{"key":"bibr30-0020731420979824","unstructured":"Arthur R. AstraZeneca resumes US COVID-19 vaccine trial; expects results later this year. https:\/\/www.biopharma-reporter.com\/Article\/2020\/10\/26\/AstraZeneca-resumes-US-COVID-19-vaccine-trial. Published 2020. Updated November 5, 2020. 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