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Risk-Based Data Monitoring: Quality Control in Central Nervous System (CNS) Clinical Trials

  • Clinical Trials: Analytical Reports
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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.

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Authors and Affiliations

  1. Cronos Clinical Consulting Services, Inc., 201 S. Main Street, Lambertville, NJ, 08530, USA

    Cynthia McNamara PhD, Nina Engelhardt PhD, Christian Yavorsky PhD, Matthew Masotti BA & Guillermo Di Clemente PhD

  2. National Institute of Mental Health, Bethesda, MD, USA

    William Potter MD

Authors
  1. Cynthia McNamara PhD
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  2. Nina Engelhardt PhD
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  3. William Potter MD
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  4. Christian Yavorsky PhD
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  5. Matthew Masotti BA
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  6. Guillermo Di Clemente PhD
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Corresponding author

Correspondence to Cynthia McNamara PhD.

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McNamara, C., Engelhardt, N., Potter, W. et al. Risk-Based Data Monitoring: Quality Control in Central Nervous System (CNS) Clinical Trials. Ther Innov Regul Sci 53, 176–182 (2019). https://doi.org/10.1177/2168479018774325

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  • DOI: https://doi.org/10.1177/2168479018774325

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