Larissa Niemeyer1, Konstantin Mechler2, Jan Buitelaar3, Sarah Durston4, Bram Gooskens4, Bob Oranje4, Tobias Banaschewski1, Ralf W Dittmann1, Alexander Häge1. 1. Pediatric Psychopharmacology, Department of Child and Adolescent Psychiatry and Psychotherapy, Central Institute of Mental Health, Medical Faculty Mannheim, University of Heidelberg, J 5, 68159, Mannheim, Germany. 2. Pediatric Psychopharmacology, Department of Child and Adolescent Psychiatry and Psychotherapy, Central Institute of Mental Health, Medical Faculty Mannheim, University of Heidelberg, J 5, 68159, Mannheim, Germany. konstantin.mechler@zi-mannheim.de. 3. Department of Cognitive Neuroscience, Donders Institute for Brain, Cognition and Behavior, Radboud University Nijmegen Medical Center, Nijmegen, The Netherlands. 4. Department of Psychiatry, University Medical Center Utrecht Brain Center, Utrecht, The Netherlands.
Abstract
BACKGROUND: Low recruitment in clinical trials is a common and costly problem which undermines medical research. 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). METHODS: 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. RESULTS: In total, n = 173 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 = 73; 42.2%), no interest in the trial or trials in general (n = 40; 23.1%), and not wanting changes to current therapy/medication (n = 14; 8.1%). CONCLUSIONS: 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. TRIAL REGISTRATION: EudraCT 2014-003080-38 . Registered on 14 July 2014.
BACKGROUND: Low recruitment in clinical trials is a common and costly problem which undermines medical research. 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). METHODS: 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. RESULTS: In total, n = 173 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 = 73; 42.2%), no interest in the trial or trials in general (n = 40; 23.1%), and not wanting changes to current therapy/medication (n = 14; 8.1%). CONCLUSIONS: 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. TRIAL REGISTRATION: EudraCT 2014-003080-38 . Registered on 14 July 2014.
Authors: Konstantin Mechler; Alexander Häge; Nina Schweinfurth; Jeffrey C Glennon; Rick M Dijkhuizen; Declan Murphy; Sarah Durston; Steven Williams; Jan K Buitelaar; Tobias Banaschewski; Ralf W Dittmann; The Tactics Consortium Journal: Z Kinder Jugendpsychiatr Psychother Date: 2017-09-18
Authors: Alexander Häge; Tobias Banaschewski; Jan K Buitelaar; Rick M Dijkhuizen; Barbara Franke; David J Lythgoe; Konstantin Mechler; Steven C R Williams; Ralf W Dittmann Journal: Trials Date: 2016-03-17 Impact factor: 2.279
Authors: Larissa Niemeyer; Konstantin Mechler; Ralf W Dittmann; Tobias Banaschewski; Jan Buitelaar; Sarah Durston; Alexander Häge Journal: Contemp Clin Trials Commun Date: 2022-08-14