Abstract
Monitoring the quality of clinical trial efficacy outcome data has received increased attention in the past decade, with regulatory guidance encouraging it to be conducted proactively, and remotely. However, the methods utilized to develop and implement risk-based data monitoring (RBDM) programs vary, and there is a dearth of published material to guide these processes in the context of central nervous system (CNS) trials. We reviewed regulatory guidance published within the past 6 years, generic white papers, and studies applying RBDM to data from CNS clinical trials. Methodologic considerations and system requirements necessary to establish an effective, real-time risk-based monitoring platform in CNS trials are presented. Key RBDM terms are defined in the context of CNS trial data, such as "critical data," "risk indicators," "noninformative data," and "mitigation of risk." Additionally, potential benefits of, and challenges associated with implementation of data quality monitoring are highlighted. Application of methodological and system requirement considerations to real-time monitoring of clinical ratings in CNS trials has the potential to minimize risk and enhance the quality of clinical trial data.
References
May 1, 1994·British Journal of Clinical Pharmacology·N Baber
May 15, 2002·Journal of Clinical Psychopharmacology·Matthias J Müller, Armin Szegedi
Dec 2, 2005·Clinical Trials : Journal of the Society for Clinical Trials·Chengjie XiongZhengjun Zhang
May 6, 2008·Orphanet Journal of Rare Diseases·Shein-Chung Chow, Mark Chang
Dec 18, 2008·BJOG : an International Journal of Obstetrics and Gynaecology·D G Tincello
Jan 15, 2009·Journal of Clinical Psychopharmacology·Kenneth A KobakJanet B W Williams
Aug 14, 2010·Trials·David M KentRodney A Hayward
Nov 6, 2012·Clinical Journal of the American Society of Nephrology : CJASN·Robert N Foley, Allan J Collins
Jan 2, 2013·Journal of Clinical Psychopharmacology·Anzalee KhanSofija Jovic
Jul 19, 2013·Human Gene Therapy. Clinical Development·Alessandro AiutiCaroline Voltz-Girolt
Aug 6, 2015·Journal of Clinical Psychopharmacology·David J McCannRobert C Alexander
Mar 13, 2017·Schizophrenia Research·Jonathan RabinowitzUNKNOWN ISCTM ALGORITHMS/FLAGS TO IDENTIFY CLINICAL INCONSISTENCY IN THE USE OF RATING SCALES IN CNS RCTs working group members
Jan 19, 2018·OncoTargets and Therapy·Brett Fleisher, Sihem Ait-Oudhia
May 2, 2018·Therapeutic Innovation & Regulatory Science·Richard C ZinkAlex Dmitrienko
Mar 1, 2016·Therapeutic Innovation & Regulatory Science·David KnepperYodit Seifu
Sep 1, 2014·Therapeutic Innovation & Regulatory Science·Shelly BarnesThomas Verish
Sep 1, 2014·Therapeutic Innovation & Regulatory Science·Brett WilsonAndy Lawton
Jan 1, 2016·Therapeutic Innovation & Regulatory Science·David KnepperAndy Lawton
Jan 1, 2016·Therapeutic Innovation & Regulatory Science·Jacqueline GoughHeather Achenbach