{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,5,16]],"date-time":"2026-05-16T20:20:55Z","timestamp":1778962855507,"version":"3.51.4"},"reference-count":32,"publisher":"BMJ","issue":"11","content-domain":{"domain":["bmj.com"],"crossmark-restriction":true},"short-container-title":["BMJ Open"],"accepted":{"date-parts":[[2015,9,4]]},"published-print":{"date-parts":[[2015,11]]},"abstract":"<jats:sec>\n                    <jats:title>Objectives<\/jats:title>\n                    <jats:p>Recent decades have witnessed the development of highly innovative new antiviral drug therapies. However, there are concerns that rising costs and lengthening development times could have implications for future patient access to innovative new drugs. We sought to establish whether the time taken for the clinical development of new antiviral drugs launched in the UK had increased since the 1980s.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Design and setting<\/jats:title>\n                    <jats:p>Retrospective observational study of all new antiviral drugs licensed for use in the UK.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Primary and secondary outcome measures<\/jats:title>\n                    <jats:p>Duration of clinical development (from initiation of studies in humans to receipt of Marketing Authorisation), subdivided into clinical trial and regulatory approval periods by the date of Marketing Authorisation Application.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>48 new antiviral drugs were licensed for use in the UK between 1981 and 2014 (inclusive), over half (54%) initially for HIV infection. The overall mean duration of clinical development was 77.2\u2005months, of which 64.6\u2005months was spent in clinical trials before regulatory submission. The total time in clinical development increased from 41.7\u2005months for drugs licensed 1981\u20131992 to 91.7\u2005months for drugs licensed 2004\u20132014. This increase was accounted for by an increase in the clinical trials period and not the regulatory approval period, for which there was no observable trend. Drugs initially licensed to treat hepatitis C had a longer duration of clinical development than those indicated for other viral infections. However, the, initially shorter clinical development durations of drugs indicated for HIV infection increased more rapidly across the study period than those indicated for other viral infections.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusions<\/jats:title>\n                    <jats:p>The time spent by antiviral drugs in clinical development has increased markedly in recent decades despite many initiatives to speed access to innovative new drugs. However, this represents only one part of the translational research pathway, and a complete picture of development timeframes is lacking.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1136\/bmjopen-2015-009333","type":"journal-article","created":{"date-parts":[[2015,11,17]],"date-time":"2015-11-17T20:38:59Z","timestamp":1447792739000},"page":"e009333","update-policy":"https:\/\/doi.org\/10.1136\/crossmarkpolicy","source":"Crossref","is-referenced-by-count":10,"title":["Trends in clinical development timeframes for antiviral drugs launched in the UK, 1981\u20132014: a retrospective observational study"],"prefix":"10.1136","volume":"5","author":[{"given":"Derek J","family":"Ward","sequence":"first","affiliation":[{"name":"NIHR Horizon Scanning Research & Intelligence Centre, School of Health and Population Sciences, University of Birmingham, Birmingham, UK"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Edward","family":"Hammond","sequence":"additional","affiliation":[{"name":"NIHR Horizon Scanning Research & Intelligence Centre, School of Health and Population Sciences, University of Birmingham, Birmingham, UK"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Luan","family":"Linden-Phillips","sequence":"additional","affiliation":[{"name":"NIHR Horizon Scanning Research & Intelligence Centre, School of Health and Population Sciences, University of Birmingham, Birmingham, UK"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Andrew J","family":"Stevens","sequence":"additional","affiliation":[{"name":"Department of Public Health, Epidemiology and Biostatistics, School of Health and Population Sciences, University of Birmingham, Birmingham, UK"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"239","published-online":{"date-parts":[[2015,11,16]]},"reference":[{"key":"2025121422223154000_5.11.e009333.1","doi-asserted-by":"publisher","DOI":"10.3201\/eid0101.950101"},{"key":"2025121422223154000_5.11.e009333.2","doi-asserted-by":"crossref","first-page":"10","DOI":"10.1126\/scitranslmed.3009872","article-title":"Emerging viral diseases: confronting threats with new technologies","volume":"6","author":"Marston","year":"2014","journal-title":"Sci Transl Med"},{"key":"2025121422223154000_5.11.e009333.3","doi-asserted-by":"publisher","DOI":"10.1016\/S0140-6736(08)61113-7"},{"key":"2025121422223154000_5.11.e009333.4","doi-asserted-by":"publisher","DOI":"10.1038\/nbt0114-3"},{"key":"2025121422223154000_5.11.e009333.5","unstructured":"House of Commons Select Committee on Health. The influence of the pharmaceutical industry. London: House of Commons, 2005."},{"key":"2025121422223154000_5.11.e009333.6","unstructured":"Mestre-Ferrandiz J , Sussex J , Towse A . The R&D cost of a new medicine. London: Office of Health Economics, 2012."},{"key":"2025121422223154000_5.11.e009333.7","doi-asserted-by":"publisher","DOI":"10.1038\/nrd3681"},{"key":"2025121422223154000_5.11.e009333.8","doi-asserted-by":"publisher","DOI":"10.1038\/nrd3405"},{"key":"2025121422223154000_5.11.e009333.9","doi-asserted-by":"publisher","DOI":"10.1038\/nbt.2786"},{"key":"2025121422223154000_5.11.e009333.10","doi-asserted-by":"publisher","DOI":"10.1258\/jrsm.2011.110180"},{"key":"2025121422223154000_5.11.e009333.11","doi-asserted-by":"publisher","DOI":"10.1111\/j.1752-8062.2011.00291.x"},{"key":"2025121422223154000_5.11.e009333.12","doi-asserted-by":"publisher","DOI":"10.1038\/nrd3078"},{"key":"2025121422223154000_5.11.e009333.13","doi-asserted-by":"publisher","DOI":"10.1377\/hlthaff.25.2.461"},{"key":"2025121422223154000_5.11.e009333.14","unstructured":"US Food and Drug Administration. Investigational New Drug (IND) Application. Last update 27 Oct 2015. http:\/\/www.fda.gov\/drugs\/developmentapprovalprocess\/howdrugsaredevelopedandapproved\/approvalapplications\/investigationalnewdrugindapplication\/default.htm (accessed 16 Jun 2015)."},{"key":"2025121422223154000_5.11.e009333.15","unstructured":"US Food and Drug Administration. New Drug Application (NDA). Last update 2 Mar 2015. http:\/\/www.fda.gov\/Drugs\/DevelopmentApprovalProcess\/HowDrugsareDevelopedandApproved\/ApprovalApplications\/NewDrugApplicationNDA\/default.htm (accessed 16 Jun 2015)."},{"key":"2025121422223154000_5.11.e009333.16","doi-asserted-by":"publisher","DOI":"10.1038\/clpt.2010.286"},{"key":"2025121422223154000_5.11.e009333.17","doi-asserted-by":"crossref","first-page":"307","DOI":"10.1038\/nrd4611","article-title":"Changes in clinical trial length","volume":"14","author":"Pregelj","year":"2015","journal-title":"Nat Rev Drug Discov"},{"key":"2025121422223154000_5.11.e009333.18","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMsa1200223"},{"key":"2025121422223154000_5.11.e009333.19","unstructured":"European Commission. Detailed guidance on the request to the competent authorities for authorisation of a clinical trial on a medicinal product for human use, the notification of substantial amendments and the declaration of the end of the trial (CT-1). 2010. C82\/01. http:\/\/ec.europa.eu\/health\/files\/eudralex\/vol-10\/2010_c82_01\/2010_c82_01_en.pdf"},{"key":"2025121422223154000_5.11.e009333.20","doi-asserted-by":"crossref","first-page":"1","DOI":"10.1186\/1478-4505-13-1","article-title":"How long does biomedical research take? Studying the time taken between biomedical and health research and its translation into products, policy, and practice","volume":"13","author":"Hanney","year":"2015","journal-title":"Health Res Policy Syst"},{"key":"2025121422223154000_5.11.e009333.21","doi-asserted-by":"publisher","DOI":"10.1136\/bmj.c1862"},{"key":"2025121422223154000_5.11.e009333.22","doi-asserted-by":"publisher","DOI":"10.1136\/bmj.b1052"},{"key":"2025121422223154000_5.11.e009333.23","doi-asserted-by":"publisher","DOI":"10.1186\/1745-6215-13-53"},{"key":"2025121422223154000_5.11.e009333.24","doi-asserted-by":"publisher","DOI":"10.1136\/bmj.f7682"},{"key":"2025121422223154000_5.11.e009333.25","doi-asserted-by":"crossref","first-page":"559","DOI":"10.1038\/clpt.2014.145","article-title":"Accelerated access to innovative medicines for patients in need","volume":"96","author":"Baird","year":"2014","journal-title":"Clin Pharmacol Ther"},{"key":"2025121422223154000_5.11.e009333.26","doi-asserted-by":"crossref","first-page":"239","DOI":"10.1017\/S0266462314000348","article-title":"Is this the real life? Is this just fantasy?","volume":"30","author":"Grainger","year":"2014","journal-title":"Int J Technol Assess Health Care"},{"key":"2025121422223154000_5.11.e009333.27","doi-asserted-by":"publisher","DOI":"10.1377\/hlthaff.25.2.420"},{"key":"2025121422223154000_5.11.e009333.28","unstructured":"Medicines and Healthcare Products Regulatory Agency. Apply for the early access to medicines scheme (EAMS). https:\/\/www.gov.uk\/apply-for-the-early-access-to-medicines-scheme-eams#overview (accessed 16 Jun 2015)."},{"key":"2025121422223154000_5.11.e009333.29","doi-asserted-by":"crossref","first-page":"234","DOI":"10.1002\/cpt.59","article-title":"From adaptive licensing to adaptive pathways: delivering a flexible life-span approach to bring new drugs to patients","volume":"97","author":"Eichler","year":"2015","journal-title":"Clin Pharmacol Ther"},{"key":"2025121422223154000_5.11.e009333.30","doi-asserted-by":"crossref","first-page":"1025","DOI":"10.1016\/j.molonc.2014.10.009","article-title":"Bringing in health technology assessment and cost-effectiveness considerations at an early stage of drug development","volume":"9","author":"J\u00f6nsson","year":"2015","journal-title":"Mol Oncol"},{"key":"2025121422223154000_5.11.e009333.31","doi-asserted-by":"crossref","unstructured":"Mestre-Ferrandiz J , Deverka P , Pistollato M , et al . The current drug development paradigm: responding to US and European demands for evidence of comparative effectiveness and relative effectiveness. Occasional Paper. London: Office for Health Economics, 2014.","DOI":"10.2139\/ssrn.2637916"},{"key":"2025121422223154000_5.11.e009333.32","doi-asserted-by":"publisher","DOI":"10.1038\/clpt.2011.89"}],"container-title":["BMJ Open"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/syndication.highwire.org\/content\/doi\/10.1136\/bmjopen-2015-009333","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2025,12,15]],"date-time":"2025-12-15T06:22:42Z","timestamp":1765779762000},"score":1,"resource":{"primary":{"URL":"https:\/\/bmjopen.bmj.com\/lookup\/doi\/10.1136\/bmjopen-2015-009333"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2015,11]]},"references-count":32,"journal-issue":{"issue":"11","published-online":{"date-parts":[[2015,11,16]]},"published-print":{"date-parts":[[2015,11]]}},"alternative-id":["10.1136\/bmjopen-2015-009333"],"URL":"https:\/\/doi.org\/10.1136\/bmjopen-2015-009333","relation":{},"ISSN":["2044-6055","2044-6055"],"issn-type":[{"value":"2044-6055","type":"print"},{"value":"2044-6055","type":"electronic"}],"subject":[],"published":{"date-parts":[[2015,11]]}}}