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The impact of clinical trial monitoring approaches on data integrity and cost—a review of current literature

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Abstract

Purpose

Monitoring is a costly requirement when conducting clinical trials. New regulatory guidance encourages the industry to consider alternative monitoring methods to the traditional 100 % source data verification (SDV) approach. The purpose of this literature review is to provide an overview of publications on different monitoring methods and their impact on subject safety data, data integrity, and monitoring cost.

Methods

The literature search was performed by keyword searches in MEDLINE and hand search of key journals. All publications were reviewed for details on how a monitoring approach impacted subject safety data, data integrity, or monitoring costs.

Results

Twenty-two publications were identified. Three publications showed that SDV has some value for detection of not initially reported adverse events and centralized statistical monitoring (CSM) captures atypical trends. Fourteen publications showed little objective evidence of improved data integrity with traditional monitoring such as 100 % SDV and sponsor queries as compared to reduced SDV, CSM, and remote monitoring. Eight publications proposed a potential for significant cost reductions of monitoring by reducing SDV without compromising the validity of the trial results.

Conclusions

One hundred percent SDV is not a rational method of ensuring data integrity and subject safety based on the high cost, and this literature review indicates that reduced SDV is a viable monitoring method. Alternative methods of monitoring such as centralized monitoring utilizing statistical tests are promising alternatives but have limitations as stand-alone tools. Reduced SDV combined with a centralized, risk-based approach may be the ideal solution to reduce monitoring costs while improving essential data quality.

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Authors and Affiliations

  1. Nordic Bioscience Clinical Development A/S, Herlev Hovedgade 205-207, 2730, Herlev, Denmark

    Rasmus Olsen, Asger Reinstrup Bihlet, Faidra Kalakou & Jeppe Ragnar Andersen

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  1. Rasmus Olsen
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  2. Asger Reinstrup Bihlet
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  3. Faidra Kalakou
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  4. Jeppe Ragnar Andersen
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Correspondence to Jeppe Ragnar Andersen.

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Olsen, R., Bihlet, A.R., Kalakou, F. et al. The impact of clinical trial monitoring approaches on data integrity and cost—a review of current literature. Eur J Clin Pharmacol 72, 399–412 (2016). https://doi.org/10.1007/s00228-015-2004-y

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  • DOI: https://doi.org/10.1007/s00228-015-2004-y

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