{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2025,2,21]],"date-time":"2025-02-21T20:34:25Z","timestamp":1740170065654,"version":"3.37.3"},"reference-count":14,"publisher":"Springer Science and Business Media LLC","issue":"2","license":[{"start":{"date-parts":[[2020,11,9]],"date-time":"2020-11-09T00:00:00Z","timestamp":1604880000000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0"},{"start":{"date-parts":[[2020,11,9]],"date-time":"2020-11-09T00:00:00Z","timestamp":1604880000000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0"}],"content-domain":{"domain":["link.springer.com"],"crossmark-restriction":false},"short-container-title":["Ther Innov Regul Sci"],"published-print":{"date-parts":[[2021,3]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:sec>\n                <jats:title>Background<\/jats:title>\n                <jats:p>An important component of a systematic strategy for safety surveillance is prospective identification of anticipated serious adverse events (SAEs). Developing a structured approach to identify anticipated events and estimating their incidence can help align the safety strategy and the safety surveillance efforts.<\/jats:p>\n              <\/jats:sec><jats:sec>\n                <jats:title>Methods<\/jats:title>\n                <jats:p>We developed a novel approach to identify anticipated events for a hypothetical randomized, double-blind, controlled trial in subjects with bipolar disorder using the adverse events reported\u00a0in the\u00a0placebo arm of trials from the ClinicalTrials.gov database. We searched the ClinicalTrials.gov database for all trials on bipolar depression with similar inclusion\/exclusion criteria and study duration as our hypothetical study. The frequencies of anticipated events in placebo arms were abstracted from each trial and 95% confidence intervals (CI) were calculated using the Clopper\u2013Pearson method. Meta-analysis with a random effects model was performed to obtain a summary estimate and 95% CI for the events identified in more than one trial.<\/jats:p>\n              <\/jats:sec><jats:sec>\n                <jats:title>Results<\/jats:title>\n                <jats:p>A total of 129 clinical trials were initially identified, and 18 were ultimately selected as they met all the selection criteria. There were 69 unique anticipated SAEs identified, and 13 out of 69 were reported in at least 2 clinical trials. The top 5 anticipated SAEs for our study were: (1) hospitalization, psychiatric symptom (3.57%); (2) suicidal behavior, overdose (3.57%), (3) cholecystitis (2.86%); (4) fall (2.86%); (5) road traffic accident, injury (2.86%).<\/jats:p>\n              <\/jats:sec><jats:sec>\n                <jats:title>Conclusion<\/jats:title>\n                <jats:p>We successfully identified the anticipated events from registered trials that included a population similar to our trial. This method for identifying anticipated events could be applied to other disease areas.<\/jats:p>\n              <\/jats:sec>","DOI":"10.1007\/s43441-020-00237-w","type":"journal-article","created":{"date-parts":[[2020,11,9]],"date-time":"2020-11-09T16:07:06Z","timestamp":1604938026000},"page":"454-461","update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":0,"title":["Identifying Anticipated Events of Future Clinical Trials by Leveraging Data from the Placebo Arms of Completed Trials"],"prefix":"10.1007","volume":"55","author":[{"given":"Xiang-Lin","family":"Tan","sequence":"first","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"David M.","family":"Kern","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-5159-6217","authenticated-orcid":false,"given":"M. Soledad","family":"Cepeda","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"297","published-online":{"date-parts":[[2020,11,9]]},"reference":[{"key":"237_CR1","unstructured":"US Food & Drug Administration. Safety reporting requirements for INDs (investigational new drug applications) and BA\/BE (bioavailability\/bioequivalence) studies. https:\/\/www.fda.gov\/regulatory-information\/search-fda-guidance-documents\/safety-reporting-requirements-inds-investigational-new-drug-applications-and-babe. Accessed December 2012."},{"key":"237_CR2","unstructured":"US Food & Drug Administration. Safety assessment for IND safety reporting guidance for industry. https:\/\/www.fda.gov\/regulatory-information\/search-fda-guidance-documents\/safety-assessment-ind-safety-reporting-guidance-industry. Accessed December 2015."},{"key":"237_CR3","unstructured":"US Food & Drug Administration. Final rule: investigational new drug safety reporting requirments for human drug and biological products and safety reporting requirements for bioavailability and bioequivalence studies in humnas. https:\/\/www.fda.gov\/drugs\/investigational-new-drug-ind-application\/final-rule-investigational-new-drug-safety-reporting-requirements-human-drug-and-biological-products. Accessed June 2015."},{"issue":"9","key":"237_CR4","doi-asserted-by":"publisher","first-page":"999","DOI":"10.1016\/j.jpain.2013.06.005","volume":"14","author":"MS Cepeda","year":"2013","unstructured":"Cepeda MS, Lobanov V, Berlin JA. Using Sherlock and ClinicalTrials.gov data to understand nocebo effects and adverse event dropout rates in the placebo arm. J Pain. 2013a;14(9):999.","journal-title":"J Pain."},{"key":"237_CR5","doi-asserted-by":"crossref","unstructured":"Wyler von Ballmoos M, Oliveira C. The ClinicalTrials.gov results database. N Engl J Med. 2011;364(22):2169; author reply 70.","DOI":"10.1056\/NEJMc1103910"},{"issue":"9","key":"237_CR6","doi-asserted-by":"publisher","first-page":"852","DOI":"10.1056\/NEJMsa1012065","volume":"364","author":"DA Zarin","year":"2011","unstructured":"Zarin DA, Tse T, Williams RJ, Califf RM, Ide NC. The ClinicalTrials.gov results database\u2013update and key issues. N Engl J Med. 2011;364(9):852\u201360.","journal-title":"N Engl J Med."},{"issue":"8","key":"237_CR7","doi-asserted-by":"publisher","first-page":"824","DOI":"10.1056\/NEJMsr0806582","volume":"360","author":"AJ Wood","year":"2009","unstructured":"Wood AJ. Progress and deficiencies in the registration of clinical trials. N Engl J Med. 2009;360(8):824\u201330.","journal-title":"N Engl J Med."},{"issue":"1","key":"237_CR8","doi-asserted-by":"publisher","first-page":"295","DOI":"10.1378\/chest.08-3022","volume":"136","author":"T Tse","year":"2009","unstructured":"Tse T, Williams RJ, Zarin DA. Reporting \u201cbasic results\u201d in ClinicalTrials.gov. Chest. 2009;136(1):295\u2013303.","journal-title":"Chest"},{"issue":"4","key":"237_CR9","doi-asserted-by":"publisher","first-page":"405","DOI":"10.1016\/j.jpain.2012.12.011","volume":"14","author":"MS Cepeda","year":"2013","unstructured":"Cepeda MS, Lobanov V, Berlin JA. Use of ClinicalTrials.gov to estimate condition-specific nocebo effects and other factors affecting outcomes of analgesic trials. J Pain. 2013b;14(4):405\u201311.","journal-title":"J Pain."},{"issue":"2","key":"237_CR10","doi-asserted-by":"publisher","first-page":"347","DOI":"10.1177\/1740774513475849","volume":"10","author":"MS Cepeda","year":"2013","unstructured":"Cepeda MS, Lobanov V, Berlin JA. From ClinicalTrials.gov trial registry to an analysis-ready database of clinical trial results. Clin Trials. 2013c;10(2):347\u20138.","journal-title":"Clin Trials."},{"key":"237_CR11","doi-asserted-by":"crossref","unstructured":"Prayle AP, Hurley MN, Smyth AR. Compliance with mandatory reporting of clinical trial results on ClinicalTrials.gov: cross sectional study. BMJ. 2012;344:d7373.","DOI":"10.1136\/bmj.d7373"},{"issue":"1572","key":"237_CR12","doi-asserted-by":"publisher","first-page":"1889","DOI":"10.1098\/rstb.2010.0384","volume":"366","author":"P Enck","year":"2011","unstructured":"Enck P, Klosterhalfen S, Weimer K, Horing B, Zipfel S. The placebo response in clinical trials: more questions than answers. Philos Trans R SocLond B. 2011;366(1572):1889\u201395.","journal-title":"Philos Trans R SocLond B."},{"key":"237_CR13","doi-asserted-by":"crossref","unstructured":"Golder S, Loke YK, Wright K, Norman G. Reporting of adverse events in published and unpublished studies of health care interventions: a systematic review. PLoS Med. 2016;13(9):e1002127.","DOI":"10.1371\/journal.pmed.1002127"},{"key":"237_CR14","doi-asserted-by":"crossref","unstructured":"Bonomi P, Stuccio N, Chuk MK, Spira A, Deitz AC, Blumenthal G, et al., editors. Reducing Uninformative IND Safety Reports: A List of Serious Adverse Events anticipated to Occur in Patients with Lung Cancer2020.","DOI":"10.1007\/s43441-020-00145-z"}],"container-title":["Therapeutic Innovation &amp; Regulatory Science"],"original-title":[],"language":"en","link":[{"URL":"http:\/\/link.springer.com\/content\/pdf\/10.1007\/s43441-020-00237-w.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"http:\/\/link.springer.com\/article\/10.1007\/s43441-020-00237-w\/fulltext.html","content-type":"text\/html","content-version":"vor","intended-application":"text-mining"},{"URL":"http:\/\/link.springer.com\/content\/pdf\/10.1007\/s43441-020-00237-w.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2021,2,6]],"date-time":"2021-02-06T14:57:11Z","timestamp":1612623431000},"score":1,"resource":{"primary":{"URL":"http:\/\/link.springer.com\/10.1007\/s43441-020-00237-w"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2020,11,9]]},"references-count":14,"journal-issue":{"issue":"2","published-print":{"date-parts":[[2021,3]]}},"alternative-id":["237"],"URL":"https:\/\/doi.org\/10.1007\/s43441-020-00237-w","relation":{},"ISSN":["2168-4790","2168-4804"],"issn-type":[{"type":"print","value":"2168-4790"},{"type":"electronic","value":"2168-4804"}],"subject":[],"published":{"date-parts":[[2020,11,9]]},"assertion":[{"value":"14 September 2020","order":1,"name":"received","label":"Received","group":{"name":"ArticleHistory","label":"Article History"}},{"value":"21 October 2020","order":2,"name":"accepted","label":"Accepted","group":{"name":"ArticleHistory","label":"Article History"}},{"value":"9 November 2020","order":3,"name":"first_online","label":"First Online","group":{"name":"ArticleHistory","label":"Article History"}},{"order":1,"name":"Ethics","group":{"name":"EthicsHeading","label":"Compliance with Ethical Standards"}},{"value":"The authors have declared no conflicts of interest.","order":2,"name":"Ethics","group":{"name":"EthicsHeading","label":"Conflict of interest"}}]}}