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This study aimed to investigate the challenges faced in recruiting children and adolescents with obsessive-compulsive disorder and autism spectrum disorder for a randomized, double-blind, placebo-controlled clinical trial and to analyze reasons for non-participation. The trial was part of the EU FP7 project TACTICS (Translational Adolescent and Childhood Therapeutic Interventions in Compulsive Syndromes).<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>Demographic data on pre-screening patients were collected systematically, including documented reasons for non-participation. Findings were grouped according to content, and descriptive statistical analyses of the data were performed.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>\n                      In total,\n                      <jats:italic>n<\/jats:italic>\n                      \u2009=\u2009173 patients were pre-screened for potential participation in the clinical trial. Of these, only five (2.9%) were eventually enrolled. The main reasons for non-inclusion were as follows: failure to meet all inclusion criteria\/meeting one or more of the exclusion criteria (\n                      <jats:italic>n<\/jats:italic>\n                      \u2009=\u200973; 42.2%), no interest in the trial or trials in general (\n                      <jats:italic>n<\/jats:italic>\n                      \u2009=\u200940; 23.1%), and not wanting changes to current therapy\/medication (\n                      <jats:italic>n<\/jats:italic>\n                      \u2009=\u200914; 8.1%).\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusions<\/jats:title>\n                    <jats:p>The findings from this study add valuable information to the existing knowledge on reasons for low clinical trial recruitment rates in pediatric psychiatric populations. Low enrollment and high exclusion rates raise the question of whether such selective study populations are representative of clinical patient cohorts. Consequently, the generalizability of the results of such trials may be limited. The present findings will be useful in the development of improved recruitment strategies and may guide future research in establishing the measurement of representativeness to ensure enhanced external validity in psychopharmacological clinical trials in pediatric populations.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Trial registration<\/jats:title>\n                    <jats:p>\n                      EudraCT\n                      <jats:ext-link xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" ext-link-type=\"uri\" xlink:href=\"https:\/\/www.clinicaltrialsregister.eu\/ctr-search\/search?query=2014-003080-38\">2014-003080-38<\/jats:ext-link>\n                      . Registered on 14 July 2014.\n                    <\/jats:p>\n                  <\/jats:sec>","DOI":"10.1186\/s13063-021-05119-6","type":"journal-article","created":{"date-parts":[[2021,3,1]],"date-time":"2021-03-01T15:02:58Z","timestamp":1614610978000},"update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":9,"title":["\u201cInclude me if you can\u201d\u2014reasons for low enrollment of pediatric patients in a psychopharmacological trial"],"prefix":"10.1186","volume":"22","author":[{"given":"Larissa","family":"Niemeyer","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-5322-7140","authenticated-orcid":false,"given":"Konstantin","family":"Mechler","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jan","family":"Buitelaar","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Sarah","family":"Durston","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Bram","family":"Gooskens","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Bob","family":"Oranje","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Tobias","family":"Banaschewski","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ralf W.","family":"Dittmann","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Alexander","family":"H\u00e4ge","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"297","published-online":{"date-parts":[[2021,3,1]]},"reference":[{"issue":"12","key":"5119_CR1","doi-asserted-by":"publisher","first-page":"1131","DOI":"10.1136\/adc.2004.050468","volume":"89","author":"IC Wong","year":"2004","unstructured":"Wong IC, Murray ML, Camilleri-Novak D, Stephens P. 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Further applications for ethical approvals in the UK (National Research Ethics Service Committee London \u2013 Camberwell St Giles) and in the Netherlands (Commissie Mensgebonden Onderzoek, Regio Arnhem-Nijmegen) were granted in June 2016 (Nijmegen), March 2017 (Utrecht), and June 2018 (London), respectively. Subjects and their parents\/legal guardians received informed assent\/consent documents explaining the study and its potential risks and benefits. Informed assent and consent forms were signed before inclusion.","order":1,"name":"Ethics","group":{"name":"EthicsHeading","label":"Ethics approval and consent to participate"}},{"value":"Not applicable","order":2,"name":"Ethics","group":{"name":"EthicsHeading","label":"Consent for publication"}},{"value":"Larissa Niemeyer was involved as investigator in a clinical trial by Servier. The present work is unrelated to this relationship.Konstantin Mechler has served as investigator in clinical trials conducted by Lundbeck, Shire, Sunovion, and Teva, plus in European Union funded projects.Jan Buitelaar has been in the past 3\u2009years a consultant to\/member of advisory board of\/and\/or speaker for Takeda\/Shire, Roche, Medice, and Servier. He is not an employee of any of these companies and not a stock shareholder of any of these companies. He has no other financial or material support, including expert testimony, patents, and royalties.Sarah Durston reports no potential conflicts of interest.Bram Gooskens reports no potential conflicts of interest.Bob Oranje: reports no potential conflicts of interest.Tobias Banaschewski served in an advisory or consultancy role for Lundbeck, Medice, Neurim Pharmaceuticals, Oberberg GmbH, Shire, and Infectopharm. He received conference support or speaker\u2019s fee by Lilly, Medice, and Shire. He received royalties from Hogrefe, Kohlhammer, CIP Medien, Oxford University Press. The present work is unrelated to the above grants and relationships.Ralf W. Dittmann has received compensation for serving as consultant or speaker, or he or the institution he works for have received research support or royalties from the organizations or companies indicated: EU (FP7 Programme), US National Institute of Mental Health (NIMH), German Federal Ministry of Health\/Regulatory Agency (BMG\/BfArM), German Federal Ministry of Education and Research (BMBF), German Research Foundation (DFG), Volkswagen Foundation; Boehringer Ingelheim, Ferring, Janssen-Cilag, Lilly, Lundbeck, Otsuka, Servier, Shire, Sunovion\/Takeda, and Theravance. He owns Eli Lilly stock.Alexander H\u00e4ge has received conference support, speaker\u2019s fee and\/or served in an advisory role for Shire\/Takeda and Lily. He was involved as investigator in clinical trials by Shire, Janssen-Cilag, Otsuka, Sunovion, Servier, Lundbeck, Takeda, Nuvelution, Gedeon Richter, and Emalex. The present work is unrelated to the above relationships.","order":3,"name":"Ethics","group":{"name":"EthicsHeading","label":"Competing interests"}}],"article-number":"178"}}