{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,29]],"date-time":"2026-09-29T14:22:57Z","timestamp":1790691777058,"version":"4.1.0"},"reference-count":20,"publisher":"Springer Science and Business Media LLC","issue":"1","license":[{"start":{"date-parts":[[2022,11,30]],"date-time":"2022-11-30T00:00:00Z","timestamp":1669766400000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0"},{"start":{"date-parts":[[2022,11,30]],"date-time":"2022-11-30T00:00:00Z","timestamp":1669766400000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0"}],"funder":[{"DOI":"10.13039\/501100001809","name":"the National Natural Science Foundation of China","doi-asserted-by":"crossref","award":["No. 82073033"],"award-info":[{"award-number":["No. 82073033"]}],"id":[{"id":"10.13039\/501100001809","id-type":"DOI","asserted-by":"crossref"}]}],"content-domain":{"domain":["link.springer.com"],"crossmark-restriction":false},"short-container-title":["BMC Gastroenterol"],"abstract":"<jats:title>Abstract<\/jats:title><jats:sec>\n                <jats:title>Background<\/jats:title>\n                <jats:p>Gastric cancer is one of the leading cancer-related death causes. Enormous efforts have been focused on this field in these years. However, clinical trial failure is becoming a massive obstacle for researchers to apply their research results for clinical use. This study aimed to analyze the reasons behind clinical failures and identify potential risk factors of clinical trial failures.<\/jats:p>\n              <\/jats:sec><jats:sec>\n                <jats:title>Methods<\/jats:title>\n                <jats:p>On December, 1, 2021, we queried ClinicalTrials.gov for gastric cancer listed in phase II\/III. We included trials specifying their interests in \u201cstomach cancer\u201d, \u201cStomach Neoplasms\u201d, \u201cGastric Cancer\u201d, \u201cGastric Neoplasms\u201d, \u201cGastric Carcinoma\u201d, \u201cStomach Carcinoma\u201d, \u201cGastroesophageal Junction Cancer\u201d. Exclude criteria are: (1) Trials that start prior to 01\/01\/2007 and start after 12\/01\/2020; (2) Trials with \u201cnot yet recruiting\u201d, \u201csuspended\u201d, \u201cwithdrawn\u201d, or \u201cunknown\u201d status; (3) Trials do not provide an anticipated accrual number or a start date.<\/jats:p>\n              <\/jats:sec><jats:sec>\n                <jats:title>Results<\/jats:title>\n                <jats:p>A total of 567 trials are included. 10.2% of these trials are failed. 16 (2.82%) were terminated for good reasons, and 42 (7.41%) were terminated for bad reasons. Multi-centre (<jats:italic>P<\/jats:italic>-value\u2009=\u20090.088) and anticipated accrual (<jats:italic>P<\/jats:italic>-value\u2009=\u20090.099) are potential risk factors for clinical failures in the simple logistic regression model. After considering the interaction between multi-centre and anticipated accrual, the odds ratio of anticipated accrual is 0.60 (<jats:italic>P<\/jats:italic>-value\u2009=\u20090.009) in single centre trials. In multi-centre trials, the odds ratio of anticipated accrual is 0.72 (<jats:italic>P<\/jats:italic>-value\u2009=\u20090.025). The primary reason for gastric cancer trial terminations is recruitment failure.<\/jats:p>\n              <\/jats:sec><jats:sec>\n                <jats:title>Conclusion<\/jats:title>\n                <jats:p>The rate that trials terminated in gastric cancer has decreased compared to previous studies. Comparing to other types of oncology trials, poor accrual continues to be the predominant reason, followed by business or sponsor reasons. Single-center trials with smaller anticipated accrual number are more likely to be terminated which may resulted by limited resources invested to the trial. Single-center design exacerbated the difficulty of participant recruitment. Future studies need to continue tracking the rate of trial termination across oncology and whether the reasons behind them have changed.<\/jats:p>\n              <\/jats:sec>","DOI":"10.1186\/s12876-022-02592-4","type":"journal-article","created":{"date-parts":[[2022,11,30]],"date-time":"2022-11-30T18:10:48Z","timestamp":1669831848000},"update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":10,"title":["Assessing clinical trial failure risk factors and reasons in gastric cancer"],"prefix":"10.1186","volume":"22","author":[{"given":"Zikai","family":"Zhang","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Junyi","family":"Yin","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yang","family":"Yue","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yang","family":"Su","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Hong","family":"Jiang","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"297","published-online":{"date-parts":[[2022,11,30]]},"reference":[{"key":"2592_CR1","unstructured":"World Health Organization (WHO) Fact sheet 2021."},{"issue":"3","key":"2592_CR2","doi-asserted-by":"publisher","first-page":"209","DOI":"10.3322\/caac.21660","volume":"71","author":"H Sung","year":"2021","unstructured":"Sung H, Ferlay J, Siegel RL, Laversanne M, Soerjomataram I, Jemal A, Bray F. Global cancer statistics 2020: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries. CA Cancer J Clin. 2021;71(3):209\u201349.","journal-title":"CA Cancer J Clin"},{"key":"2592_CR3","doi-asserted-by":"crossref","unstructured":"Tse T, Fain KM, Zarin DA. How to avoid common problems when using ClinicalTrials. gov in research: 10 issues to consider. BMJ. 2018;361:1\u20137.","DOI":"10.1136\/bmj.k1452"},{"issue":"17","key":"2592_CR4","doi-asserted-by":"publisher","first-page":"1861","DOI":"10.1001\/jama.2012.4230","volume":"307","author":"K Dickersin","year":"2012","unstructured":"Dickersin K, Rennie DJJ. The evolution of trial registries and their use to assess the clinical trial enterprise. JAMA. 2012;307(17):1861\u20134.","journal-title":"JAMA"},{"key":"2592_CR5","doi-asserted-by":"crossref","unstructured":"Stensland KD, McBride RB, Latif A, Wisnivesky J, Hendricks R, Roper N, Boffetta P, Hall SJ, Oh WK. Galsky MD. Adult cancer clinical trials that fail to complete: An epidemic?\u00a0JNCI: Journal of the National Cancer Institute. 2014;106(9):1-6.","DOI":"10.1093\/jnci\/dju229"},{"issue":"35","key":"2592_CR6","doi-asserted-by":"publisher","first-page":"5197","DOI":"10.1200\/JCO.2010.31.5382","volume":"28","author":"EL Korn","year":"2010","unstructured":"Korn EL, Freidlin B, Mooney M, Abrams JS. Accrual experience of national cancer institute cooperative group phase III trials activated from 2000 to 2007. J Clin Oncol. 2010;28(35):5197.","journal-title":"J Clin Oncol"},{"key":"2592_CR7","unstructured":"Faltering Cancer Trials. NewYork Times 2010."},{"issue":"12","key":"2592_CR8","doi-asserted-by":"publisher","first-page":"817","DOI":"10.1038\/nrd.2016.184","volume":"15","author":"RK Harrison","year":"2016","unstructured":"Harrison RK. Phase II and phase III failures: 2013\u20132015. Nat Rev Drug Discov. 2016;15(12):817\u20138.","journal-title":"Nat Rev Drug Discov"},{"issue":"2","key":"2592_CR9","doi-asserted-by":"publisher","first-page":"213","DOI":"10.1016\/j.ahj.2014.04.013","volume":"168","author":"S Bernardez-Pereira","year":"2014","unstructured":"Bernardez-Pereira S, Lopes RD, Carrion MJM, Santucci EV, Soares RM, de Oliveira Abreu M, Laranjeira LN, Ikeoka DT, Zazula AD, Moreira FR. Prevalence, characteristics, and predictors of early termination of cardiovascular clinical trials due to low recruitment: insights from the ClinicalTrials. gov registry. Am Heart J. 2014;168(2):213\u20139.","journal-title":"Am Heart J"},{"key":"2592_CR10","doi-asserted-by":"crossref","unstructured":"Stensland KD, DePorto K, Ryan J, Kaffenberger S, Reinstatler LS, Galsky M, Canes D, Skolarus TA, Moinzadeh A. Estimating the rate and reasons of clinical trial failure in urologic oncology. In: Urologic oncology: seminars and original investigations. 2021;39(3):154-160.","DOI":"10.1016\/j.urolonc.2020.10.070"},{"issue":"3","key":"2592_CR11","doi-asserted-by":"publisher","first-page":"210","DOI":"10.1002\/cpt.16","volume":"97","author":"K Romero","year":"2015","unstructured":"Romero K, Ito K, Rogers J, Polhamus D, Qiu R, Stephenson D, Mohs R, Lalonde R, Sinha V, Wang Y, et al. The future is now: model-based clinical trial design for Alzheimer\u2019s disease. Clin Pharmacol Therap. 2015;97(3):210\u20134.","journal-title":"Clin Pharmacol Therap"},{"key":"2592_CR12","doi-asserted-by":"publisher","first-page":"614","DOI":"10.1200\/CCI.20.00031","volume":"4","author":"K Stensland","year":"2020","unstructured":"Stensland K, Kaffenberger S, Canes D, Galsky M, Skolarus T, Moinzadeh A. Assessing genitourinary cancer clinical trial accrual sufficiency using archived trial data. JCO Clin Cancer Inform. 2020;4:614\u201322.","journal-title":"JCO Clin Cancer Inform"},{"issue":"5","key":"2592_CR13","doi-asserted-by":"publisher","first-page":"e0127242","DOI":"10.1371\/journal.pone.0127242","volume":"10","author":"RJ Williams","year":"2015","unstructured":"Williams RJ, Tse T, DiPiazza K, Zarin DA. Terminated trials in the ClinicalTrials. gov results database: evaluation of availability of primary outcome data and reasons for termination. PLoS ONE. 2015;10(5):e0127242.","journal-title":"PLoS ONE"},{"key":"2592_CR14","doi-asserted-by":"publisher","first-page":"45","DOI":"10.1016\/j.conctc.2017.11.010","volume":"9","author":"JJ Hardesty","year":"2018","unstructured":"Hardesty JJ, Kanarek NF. Barriers to non-small cell lung cancer trial eligibility. Contemp Clin Trials Commun. 2018;9:45\u20139.","journal-title":"Contemp Clin Trials Commun"},{"issue":"9","key":"2592_CR15","first-page":"1100","volume":"21","author":"EQ Lee","year":"2019","unstructured":"Lee EQ, Chukwueke UN, Hervey-Jumper SL, De Groot JF, Leone JP, Armstrong TS, Chang SM, Arons D, Oliver K, Verble K. Barriers to accrual and enrollment in brain tumor trials. Neurooncology. 2019;21(9):1100\u201317.","journal-title":"Neurooncology"},{"issue":"10","key":"2592_CR16","doi-asserted-by":"publisher","first-page":"1242","DOI":"10.1634\/theoncologist.2017-0628","volume":"23","author":"HT Borno","year":"2018","unstructured":"Borno HT, Zhang L, Siegel A, Chang E, Ryan CJ. At what cost to clinical trial enrollment? A retrospective study of patient travel burden in cancer clinical trials. Oncologist. 2018;23(10):1242\u20139.","journal-title":"Oncologist"},{"issue":"1","key":"2592_CR17","doi-asserted-by":"publisher","first-page":"77","DOI":"10.1177\/1740774514558307","volume":"12","author":"B Carlisle","year":"2015","unstructured":"Carlisle B, Kimmelman J, Ramsay T, MacKinnon N. Unsuccessful trial accrual and human subjects protections: an empirical analysis of recently closed trials. Clin Trial. 2015;12(1):77\u201383.","journal-title":"Clin Trial"},{"issue":"6","key":"2592_CR18","doi-asserted-by":"publisher","first-page":"1414","DOI":"10.1158\/1078-0432.CCR-16-2439","volume":"23","author":"C Tang","year":"2017","unstructured":"Tang C, Sherman SI, Price M, Weng J, Davis SE, Hong DS, Yao JC, Buzdar A, Wilding G, Lee JJ. Clinical trial characteristics and barriers to participant accrual: the MD Anderson cancer center experience over 30 years, a historical foundation for trial improvement. Clin Cancer Res. 2017;23(6):1414\u201321.","journal-title":"Clin Cancer Res"},{"issue":"9","key":"2592_CR19","doi-asserted-by":"publisher","first-page":"1104","DOI":"10.6004\/jnccn.2017.0150","volume":"15","author":"C Parker","year":"2017","unstructured":"Parker C, Snyder R, Jefford M, Dilts D, Wolfe R, Millar J. A randomized controlled trial of an additional funding intervention to improve clinical trial enrollment. J Natl Compr Cancer Netw. 2017;15(9):1104\u201310.","journal-title":"J Natl Compr Cancer Netw"},{"issue":"12","key":"2592_CR20","doi-asserted-by":"publisher","first-page":"1494","DOI":"10.1634\/theoncologist.2018-0003","volume":"23","author":"M Khunger","year":"2018","unstructured":"Khunger M, Rakshit S, Hernandez AV, Pasupuleti V, Glass K, Galsky MD, Grivas P. Premature clinical trial discontinuation in the era of immune checkpoint inhibitors. Oncol. 2018;23(12):1494.","journal-title":"Oncol"}],"updated-by":[{"DOI":"10.1186\/s12876-023-02642-5","type":"correction","label":"Correction","source":"publisher","updated":{"date-parts":[[2023,2,9]],"date-time":"2023-02-09T00:00:00Z","timestamp":1675900800000}}],"container-title":["BMC Gastroenterology"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/link.springer.com\/content\/pdf\/10.1186\/s12876-022-02592-4.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/link.springer.com\/article\/10.1186\/s12876-022-02592-4\/fulltext.html","content-type":"text\/html","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/link.springer.com\/content\/pdf\/10.1186\/s12876-022-02592-4.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2024,9,6]],"date-time":"2024-09-06T09:45:25Z","timestamp":1725615925000},"score":1,"resource":{"primary":{"URL":"https:\/\/bmcgastroenterol.biomedcentral.com\/articles\/10.1186\/s12876-022-02592-4"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2022,11,30]]},"references-count":20,"journal-issue":{"issue":"1","published-online":{"date-parts":[[2022,12]]}},"alternative-id":["2592"],"URL":"https:\/\/doi.org\/10.1186\/s12876-022-02592-4","relation":{"correction":[{"id-type":"doi","id":"10.1186\/s12876-023-02642-5","asserted-by":"object"}]},"ISSN":["1471-230X"],"issn-type":[{"value":"1471-230X","type":"electronic"}],"subject":[],"published":{"date-parts":[[2022,11,30]]},"assertion":[{"value":"25 May 2022","order":1,"name":"received","label":"Received","group":{"name":"ArticleHistory","label":"Article History"}},{"value":"23 November 2022","order":2,"name":"accepted","label":"Accepted","group":{"name":"ArticleHistory","label":"Article History"}},{"value":"30 November 2022","order":3,"name":"first_online","label":"First Online","group":{"name":"ArticleHistory","label":"Article History"}},{"value":"9 February 2023","order":4,"name":"change_date","label":"Change Date","group":{"name":"ArticleHistory","label":"Article History"}},{"value":"Correction","order":5,"name":"change_type","label":"Change Type","group":{"name":"ArticleHistory","label":"Article History"}},{"value":"A Correction to this paper has been published:","order":6,"name":"change_details","label":"Change Details","group":{"name":"ArticleHistory","label":"Article History"}},{"value":"https:\/\/doi.org\/10.1186\/s12876-023-02642-5","URL":"https:\/\/doi.org\/10.1186\/s12876-023-02642-5","order":7,"name":"change_details","label":"Change Details","group":{"name":"ArticleHistory","label":"Article History"}},{"order":1,"name":"Ethics","group":{"name":"EthicsHeading","label":"Declarations"}},{"value":"All methods were carried out in accordance with relevant guidelines and regulations.","order":2,"name":"Ethics","group":{"name":"EthicsHeading","label":"Ethics approval and consent to participate"}},{"value":"Not applicable.","order":3,"name":"Ethics","group":{"name":"EthicsHeading","label":"Consent for publication"}},{"value":"The authors declare that they have no competing interests.","order":4,"name":"Ethics","group":{"name":"EthicsHeading","label":"Competing interests"}}],"article-number":"496"}}