Article
Risk Assessment of Clinical Trials Protocols with the Risk Based Monitoring Tools
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Authors
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Firas Fneish
- Leibniz Universität Hannover, Institute of Biostatistics, Hannover, Germany
| Published: | September 6, 2019 |
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Outline
Text
Clinical trial monitoring involves intensive on-site monitoring visits at clinical trial sites and exhaustive source data verification (SDV) of clinical trial data [1]. In recent years clinical researchers have questioned the validity and necessity for traditional monitoring methods [2]. Many consider it to be an expensive, time-consuming and resource heavy activity that does not guarantee the quality of clinical trial data or the protection of trial participants [3]. The adapted ICH (GCP) guideline suggests different recommendations to the sponsor to improve overall quality management in a clinical trial. One of the recommendations is to implement a risk based approach monitoring system. A risk based monitoring approach involves the identification of any risk that might have an effect on areas routinely subject during monitoring activities. These risks should be identified at system and clinical trial level, followed by a systematic evaluation of these risks and their likelihood of occurring and the extent to detect these errors and their impact on human subject protection, trial data reliability and GCP- and protocol compliance [4]. Until today various tools for risk identification have been developed as either paper based or electronic RBM [5], [6]. These tools have been compared on their characteristics, and the strategy to decrease the risk by each tool, however the effectiveness of RBM tools and differences still need to be examined [6]. The aim of the research is to apply noncommercial RBM tools (ADAMON, OPTIMON, TRANSCELERATE, SWISS, NORM, YEE, and MHRA) to clinical protocols and compare the outcome risks detected, additionally the overall risk assessment of the protocols. Moreover to compare the risks being investigated by each RBM tool and to which extent is it covered. Approximately all RBM tools excluding NORM and TRANSCELERATE RMB tools have reached to similar overall risk assessment but the risks detected and their impact within each RBM tool were different, hence the outcome mitigation plan of each RBM tool varied as well.
The authors declare that they have no competing interests.
The authors declare that an ethics committee vote is not required.
References
- 1.
- Food and Drug Administration (FDA). Guidance for Industry: Oversight of Clinical Investigations — A Risk-Based Approach to Monitoring. 2013 [Accessed 18 July 2019]. Available from: http://www.fda.gov/downloads/Drugs/.../Guidances/UCM269919.pdf
- 2.
- Uren SC, Kirkman MB, Dalton BS, Zalcberg JR. Reducing clinical trial monitoring resource allocation and costs through remote access to electronic medical records. Journal of oncology practice. 2013;9(1):e13-6.
- 3.
- Olsen R, Bihlet AR, Kalakou F, Andersen JR. The impact of clinical trial monitoring approaches on data integrity and cost - a review of current literature. European journal of clinical pharmacology. 2016;72(4):399-412.
- 4.
- E6 (R2) Good Clinical Practice: Integrated Addendum to ICH E6 (R1)-Guidance for Industry - Guideline for Good Clinical Practice - E6 (R2). 2018.
- 5.
- Journot V, Pignon JP, Gaultier C, Daurat V, Bouxin-Métro A, Giraudeau B, Preux PM, Tréluyer JM, Chevret S, Plättner V, Thalamas C. Validation of a risk-assessment scale and a risk-adapted monitoring plan for academic clinical research studies — the pre-optimon study. Control Clin Trials. 2011;32(1):16–24.
- 6.
- MRC/DH/MHRA Joint Project. Risk-Adapted Approaches to the Management of Clinical Trials of Investigational Medicinal Products. 2011.
- 7.
- Hurley C, Shiely F, Power J, Clarke M, Eustace JA, Flanagan E, Kearney PM. Risk based monitoring (RBM) tools for clinical trials: A systematic review. Contemporary Clinical Trials. 2016 Nov;51:15-27. DOI: 10.1016/j.cct.2016.09.003
