{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,15]],"date-time":"2026-09-15T18:06:28Z","timestamp":1789495588378,"version":"build-2803163510"},"reference-count":58,"publisher":"Wiley","issue":"4","license":[{"start":{"date-parts":[[2023,10,18]],"date-time":"2023-10-18T00:00:00Z","timestamp":1697587200000},"content-version":"vor","delay-in-days":17,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc-nd\/4.0\/"}],"content-domain":{"domain":["alz-journals.onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["A&amp;amp;D Transl Res &amp;amp; Clin Interv"],"published-print":{"date-parts":[[2023,10]]},"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:sec>\n                    <jats:label\/>\n                    <jats:p>The efficient and accurate execution of clinical trials testing novel treatments for Alzheimer's disease (AD) is a critical component of the field's collective efforts to develop effective disease\u2010modifying treatments for AD. The lengthy and heterogeneous nature of clinical progression in AD contributes to the challenges inherent in demonstrating a clinically meaningful benefit of any potential new AD therapy. The failure of many large and expensive clinical trials to date has prompted a focus on optimizing all aspects of decision making, to not only expedite the development of new treatments, but also maximize the value of the information that each clinical trial yields, so that all future clinical trials (including those that are negative) will contribute toward advancing the field. To address this important topic the Alzheimer's Association Research Roundtable convened December 1\u20132, 2020. The goals focused around identifying new directions and actionable steps to enhance clinical trial decision making in planned future studies.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1002\/trc2.12421","type":"journal-article","created":{"date-parts":[[2023,10,19]],"date-time":"2023-10-19T01:29:50Z","timestamp":1697678990000},"update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":3,"title":["Decision making in clinical trials: Interim analyses, innovative design, and biomarkers"],"prefix":"10.1002","volume":"9","author":[{"given":"Kathleen A.","family":"Welsh\u2010Bohmer","sequence":"first","affiliation":[{"name":"Department of Psychiatry &amp; Neurology Duke University  Durham North Carolina USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Geoffrey A.","family":"Kerchner","sequence":"additional","affiliation":[{"name":"Pharma Research and Early Development F. Hoffmann\u2010La Roche, Ltd  Basel Switzerland"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Shobha","family":"Dhadda","sequence":"additional","affiliation":[{"name":"Eisai Inc.  Nutley New Jersey USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Miguel","family":"Garcia","sequence":"additional","affiliation":[{"name":"Boehringer Ingelheim Pharmaceuticals Inc.  Ridgefield Connecticut USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"David S.","family":"Miller","sequence":"additional","affiliation":[{"name":"Signant Health  Blue Bell Pennsylvania USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Fanni","family":"Natanegara","sequence":"additional","affiliation":[{"name":"Eli Lilly and Company Lilly Corporate Center  Indianapolis Indiana USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Lars Lau","family":"Raket","sequence":"additional","affiliation":[{"name":"Novo Nordisk A\/S  S\u00f8borg Denmark"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Weining","family":"Robieson","sequence":"additional","affiliation":[{"name":"AbbVie  North Chicago Illinois USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Eric R.","family":"Siemers","sequence":"additional","affiliation":[{"name":"ACUMEN Pharmaceuticals  Charlottesville Virginia USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Maria C.","family":"Carrillo","sequence":"additional","affiliation":[{"name":"Alzheimer's Association  Chicago Illinois USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Christopher J.","family":"Weber","sequence":"additional","affiliation":[{"name":"Alzheimer's Association  Chicago Illinois USA"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2023,10,18]]},"reference":[{"key":"e_1_2_9_2_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.jalz.2018.02.018"},{"key":"e_1_2_9_3_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.jalz.2011.10.007"},{"key":"e_1_2_9_4_1","unstructured":"World Health Organization (WHO).Global status report on the public health response to dementia.Geneva.2021."},{"key":"e_1_2_9_5_1","doi-asserted-by":"publisher","DOI":"10.1038\/s41593\u2010020\u20100687\u20106"},{"key":"e_1_2_9_6_1","doi-asserted-by":"publisher","DOI":"10.1186\/s12874\u2010020\u20100899\u20101"},{"key":"e_1_2_9_7_1","doi-asserted-by":"publisher","DOI":"10.14283\/jpad.2020.20"},{"key":"e_1_2_9_8_1","doi-asserted-by":"publisher","DOI":"10.1038\/s41582\u2010020\u201000454\u20109"},{"key":"e_1_2_9_9_1","doi-asserted-by":"publisher","DOI":"10.14283\/jpad.2022.30"},{"key":"e_1_2_9_10_1","doi-asserted-by":"publisher","DOI":"10.14283\/jpad.2020.29"},{"key":"e_1_2_9_11_1","doi-asserted-by":"publisher","DOI":"10.1001\/jama.2015.4668"},{"key":"e_1_2_9_12_1","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa1304839"},{"key":"e_1_2_9_13_1","doi-asserted-by":"publisher","DOI":"10.1007\/978\u20103\u2010030\u201005542\u20104_2"},{"key":"e_1_2_9_14_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.bionps.2019.100005"},{"key":"e_1_2_9_15_1","doi-asserted-by":"publisher","DOI":"10.3390\/ph14020110"},{"key":"e_1_2_9_16_1","doi-asserted-by":"publisher","DOI":"10.1038\/s41380\u2010018\u20100342\u20108"},{"key":"e_1_2_9_17_1","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa2100708"},{"key":"e_1_2_9_18_1","doi-asserted-by":"publisher","DOI":"10.1097\/NEN.0000000000000016"},{"key":"e_1_2_9_19_1","doi-asserted-by":"publisher","DOI":"10.1016\/S0140\u20106736(15)60461\u20105"},{"key":"e_1_2_9_20_1","doi-asserted-by":"publisher","DOI":"10.1038\/s41591\u2010020\u20100755\u20101"},{"key":"e_1_2_9_21_1","doi-asserted-by":"publisher","DOI":"10.1001\/jama.2020.12134"},{"key":"e_1_2_9_22_1","doi-asserted-by":"publisher","DOI":"10.1212\/WNL.0000000000008081"},{"key":"e_1_2_9_23_1","doi-asserted-by":"publisher","DOI":"10.1016\/S0140\u20106736(15)01124\u20101"},{"key":"e_1_2_9_24_1","doi-asserted-by":"publisher","DOI":"10.1093\/brain\/awv029"},{"key":"e_1_2_9_25_1","doi-asserted-by":"publisher","DOI":"10.1016\/S1474\u20104422(19)30283\u20102"},{"key":"e_1_2_9_26_1","doi-asserted-by":"publisher","DOI":"10.1093\/brain\/awaa248"},{"key":"e_1_2_9_27_1","doi-asserted-by":"publisher","DOI":"10.1007\/s00259\u2010021\u201005253\u2010y"},{"key":"e_1_2_9_28_1","doi-asserted-by":"publisher","DOI":"10.1002\/alz.12363"},{"key":"e_1_2_9_29_1","doi-asserted-by":"publisher","DOI":"10.1038\/s43587\u2010020\u201000003\u20105"},{"key":"e_1_2_9_30_1","doi-asserted-by":"publisher","DOI":"10.1212\/WNL.0000000000010747"},{"key":"e_1_2_9_31_1","unstructured":"U.S. Department of Health and Human Services (HHS) Food and Drug Administration (FDA) Center for Drug Evaluation and Research (CDER) Center for Biologics Evaluation. Early Alzheimer's Disease: Developing Drugs for Treatment Guidelines for Industry.2018"},{"issue":"1","key":"e_1_2_9_32_1","article-title":"Utility of plasma neurofilament light and total tau for clinical trials in Alzheimer's disease.\u2019\u2019 Alzheimer's & Dementia: diagnosis","volume":"12","author":"Raket LL","year":"2020","journal-title":"Assess Dis Monit"},{"key":"e_1_2_9_33_1","doi-asserted-by":"publisher","DOI":"10.3389\/fnins.2021.642384"},{"key":"e_1_2_9_34_1","doi-asserted-by":"publisher","DOI":"10.1212\/WNL.0000000000009097"},{"key":"e_1_2_9_35_1","doi-asserted-by":"publisher","DOI":"10.14283\/jpad.2019.30"},{"key":"e_1_2_9_36_1","doi-asserted-by":"publisher","DOI":"10.1093\/geroni\/igy038"},{"key":"e_1_2_9_37_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.cmpb.2021.106484"},{"key":"e_1_2_9_38_1","doi-asserted-by":"publisher","DOI":"10.1002\/dad2.12217"},{"key":"e_1_2_9_39_1","doi-asserted-by":"publisher","DOI":"10.3389\/fdata.2020.00024"},{"key":"e_1_2_9_40_1","doi-asserted-by":"publisher","DOI":"10.1212\/WNL.0000000000007032"},{"key":"e_1_2_9_41_1","doi-asserted-by":"publisher","DOI":"10.1186\/s13195\u2010018\u20100443\u20102"},{"key":"e_1_2_9_42_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.trci.2019.04.001"},{"key":"e_1_2_9_43_1","doi-asserted-by":"publisher","DOI":"10.1186\/s12943\u2010018\u20100782\u20104"},{"key":"e_1_2_9_44_1","doi-asserted-by":"publisher","DOI":"10.3322\/caac.21600"},{"key":"e_1_2_9_45_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.jalz.2016.07.005"},{"key":"e_1_2_9_46_1","doi-asserted-by":"publisher","DOI":"10.1002\/alz.12292"},{"key":"e_1_2_9_47_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.neurobiolaging.2017.01.021"},{"key":"e_1_2_9_48_1","doi-asserted-by":"publisher","DOI":"10.1176\/ajp.141.11.1356"},{"key":"e_1_2_9_49_1","doi-asserted-by":"publisher","DOI":"10.1192\/bjp.140.6.566"},{"key":"e_1_2_9_50_1","doi-asserted-by":"publisher","DOI":"10.1177\/0962280219840383"},{"key":"e_1_2_9_51_1","doi-asserted-by":"publisher","DOI":"10.14283\/jpad.2020.1"},{"key":"e_1_2_9_52_1","doi-asserted-by":"publisher","DOI":"10.1212\/WNL.0000000000007831"},{"key":"e_1_2_9_53_1","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa1202753"},{"key":"e_1_2_9_54_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.jalz.2016.10.006"},{"key":"e_1_2_9_55_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.jalz.2016.07.005"},{"key":"e_1_2_9_56_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.trci.2016.01.001"},{"key":"e_1_2_9_57_1","unstructured":"U.S. Department of Health and Human Services (HHS) Food and Drug Administration (FDA). Adaptive Designs for Clinical Trials of Drugs and Biologics (draft guidance).2018"},{"key":"e_1_2_9_58_1","doi-asserted-by":"publisher","DOI":"10.1136\/bmj.305.6847.235"},{"key":"e_1_2_9_59_1","doi-asserted-by":"publisher","DOI":"10.1002\/alz.12732"}],"container-title":["Alzheimer's &amp; Dementia: Translational Research &amp; Clinical Interventions"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/alz-journals.onlinelibrary.wiley.com\/doi\/pdf\/10.1002\/trc2.12421","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2025,10,26]],"date-time":"2025-10-26T15:03:44Z","timestamp":1761491024000},"score":1,"resource":{"primary":{"URL":"https:\/\/alz-journals.onlinelibrary.wiley.com\/doi\/10.1002\/trc2.12421"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2023,10]]},"references-count":58,"journal-issue":{"issue":"4","published-print":{"date-parts":[[2023,10]]}},"alternative-id":["10.1002\/trc2.12421"],"URL":"https:\/\/doi.org\/10.1002\/trc2.12421","archive":["Portico"],"relation":{},"ISSN":["2352-8737","2352-8737"],"issn-type":[{"value":"2352-8737","type":"print"},{"value":"2352-8737","type":"electronic"}],"subject":[],"published":{"date-parts":[[2023,10]]},"assertion":[{"value":"2023-06-30","order":0,"name":"received","label":"Received","group":{"name":"publication_history","label":"Publication History"}},{"value":"2023-08-14","order":2,"name":"accepted","label":"Accepted","group":{"name":"publication_history","label":"Publication History"}},{"value":"2023-10-18","order":3,"name":"published","label":"Published","group":{"name":"publication_history","label":"Publication History"}}],"article-number":"e12421"}}