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22 - Data Safety Monitoring Boards in Alzheimer’s Disease Trials

from Section 3 - Alzheimer’s Disease Clinical Trials

Published online by Cambridge University Press:  03 March 2022

By
Emily D. Clark  and
Anton P. Porsteinsson
Edited by
Jeffrey Cummings ,
Jefferson Kinney  and
Howard Fillit
Jeffrey Cummings
Affiliation:
University of Nevada, Las Vegas
Jefferson Kinney
Affiliation:
University of Nevada, Las Vegas
Howard Fillit
Affiliation:
Alzheimer’s Drug Discovery Foundation
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Summary

The data safety monitoring board (DSMB), also known the data monitoring committee, is a multidisciplinary team of scientific experts that serve an advisory role within the operation of clinical trials. The principle responsibility of a DSMB is to monitor the conduct of trials for concerns related to participant safety and data quality through the review of interim data analyses, and then to advise trial leadership whether a study is appropriate to continue, needs to modify procedures, or should be terminated. An emphasis is placed on the responsibility of the DSMB to safeguard the rights and well-being of study participants, so it is common to see the incorporation of a DSMB into a study protocol when a trial explores an intervention with high participant risk, a trial is working with a large number of participants, or when a study is working with a particularly vulnerable population, like Alzheimer’s disease (AD) patients. This chapter reviews common DSMB roles and responsibilities as well as highlighting examples of DSMBs in practice in AD clinical research.

Keywords

DMCDSMBDRCIDMCSRCdata monitoring committeedata safety monitoring boarddata review committeeindependent data monitoring committeesafety review committee
Type
Chapter
Information
Alzheimer's Disease Drug Development
Research and Development Ecosystem
 , pp. 266 - 274
Publisher: Cambridge University Press
Print publication year: 2022

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References

Heart Special Project Committee. Organization, review, and administration of cooperative studies (Greenberg Report): a report from the Heart Special Project Committee to the National Advisory Heart Council, May 1967. Control Clin Trials 1988; 9: 137–48.Google Scholar
DeMets, DL, Ellenberg, SS. Data monitoring committees expect the unexpected. N Engl J Med 2016; 375: 1365–71.Google Scholar
National Institutes of Health. NIH guide for grants and contracts. 1979. Available at: https://grants.nih.gov/grants/guide/historical/1979_06_05_Vol_08_No_08.pdf (accessed November 14, 2020).Google Scholar
National Institutes of Health. NIH policy for data and safety monitoring. 1998. Available at: https://grants.nih.gov/grants/guide/notice-files/not98-084.html (accessed November 14, 2020).Google Scholar
International Conference on Harmonisation of Technical Requirements for Pharmaceuticals for Human Use. Integrated addendum to ICH E6(R1): guideline for good clinical practice. 2016. Available at: https://ichgcp.net/ (accessed November 14, 2020).Google Scholar
International Conference on Harmonisation of Technical Requirements for Pharmaceuticals for Human Use. Statistical principles for clinical trials. 1998. Available at: https://database.ich.org/sites/default/files/E9_Guideline.pdf (accessed November 14, 2020).Google Scholar
Food and Drug Administration. Guidance for clinical trial sponsors: establishment and operation of clinical trial data monitoring committees. March 2006. Available at: www.fda.gov/regulatory-information/search-fda-guidance-documents/establishment-and-operation-clinical-trial-data-monitoring-committees (accessed November 18, 2020).Google Scholar
Gewandter, JS, Kitt, RA, Hunsinger, MR, et al. Reporting of data monitoring boards in publications of randomized clinical trials is often deficient: ACTTION systematic review. J Clin Epidemiol 2017; 83: 101–7.Google Scholar
Calis, KA, Archdeacon, P, Bain, RP, et al. Understanding the functions and operations of data monitoring committees: survey and focus group findings. Clin Trials 2017; 14: 59–66.CrossRefGoogle ScholarPubMed
Sartor, O, Halabi, S. Independent data monitoring committees: an update and overview. Urol Oncol 2015; 33: 143–8.Google Scholar
National Institutes of Health (NIH). Further guidance on data and safety monitoring for Phase I and Phase II trials. 2000. Available at: https://grants.nih.gov/grants/guide/notice-files/not-od-00-038.html (accessed November 18, 2020).Google Scholar
US Department of Veterans Affairs. Clinical Science Research & Development (CSRD), data monitoring committee guidance. 2015. Available at: www.research.va.gov/services/csrd/data-monitoring.cfm (accessed December 3, 2020).Google Scholar
Calis, KA, Archdeacon, P, Bain, R, et al. Recommendations for data monitoring committees from the Clinical Trials Transformation Initiative. Clin Trials 2017; 14: 342–8.Google Scholar
DMC Project. CTTI recommendations: data monitoring committees. 2016. Available at: www.ctti-clinicaltrials.org/files/recommendations/dmc-recommendations.pdf (accessed November 18, 2020).Google Scholar
CTSA Collaborative DSMB Workgroup. DSMB training manual. 2018. Available at: https://tuftsctsi.wpengine.com/research-services/regulatory/data-and-safety-monitoring-board-training-manual-for-investigator-initiated-studies (accessed December 3, 2020).Google Scholar
Grant, AM, Altman, DG, Babiker, AG, et al. A proposed charter for clinical trial data monitoring committees: helping them to do their job well. Lancet 2005; 365: 711–22.Google Scholar
Neaton, JD, Grund, B, Wentworth, D. How to construct an optimal interim report: what the data monitoring committee does and doesn’t need to know. Clin Trials 2018; 15: 359–65.CrossRefGoogle ScholarPubMed
Ellenberg, SS, Fleming, TR, DeMets, DL. Data Monitoring Committees in Clinical Trials : A Practical Perspective. Newark, NJ: John Wiley & Sons Inc.; 2019.Google Scholar
Kim, K. Sequential designs for clinical trials. In Designs for Clinical Trials: Perspectives on Current Issues, Harrington, D (ed.). New York, NY: Springer; 2012: 57–80.CrossRefGoogle Scholar
Doody, RS, Raman, R, Farlow, M, et al. A Phase 3 trial of semagacestat for treatment of Alzheimer’s disease. N Engl J Med 2013; 369: 341–50.Google Scholar
Yunusa, I, El Helou, ML, Alsahali, S. Pimavanserin: a novel antipsychotic with potentials to address an unmet need of older adults with dementia-related psychosis. Front Pharmacol 2020; 11: 1–5.CrossRefGoogle ScholarPubMed
Wilhelmsen, L. Role of the data and safety monitoring committee (DSMC). Stat Med 2002; 21: 2823–9.CrossRefGoogle ScholarPubMed
Acadia Pharmaceuticals. ACADIA pharmaceuticals presents positive top-line results from pivotal Phase 3 harmony trial of pimavanserin in patients with dementia-related psychosis. 12th Clinical Trials on Alzheimer’s Disease (CTAD) Meeting, December 4-7, 2019. Available at: https://ir.acadia-pharm.com/news-releases/news-release-details/acadia-pharmaceuticals-presents-positive-top-line-results?field_nir_news_date_value (accessed December 3, 2020).Google Scholar
Alzforum.org. Biogen/Eisai halt Phase 3 aducanumab trials. Available at: www.alzforum.org/news/research-news/biogeneisai-halt-phase-3-aducanumab-trials (accessed December 10, 2020).Google Scholar
Alzforum.org. Aducanumab still needs to prove itself, researchers say. Available at: www.alzforum.org/news/research-news/aducanumab-still-needs-prove-itself-researchers-say (accessed December 10, 2020).Google Scholar
Karlawish, J. If the FDA approved Biogen’s Alzheimer’s treatment, I won’t prescribe it. Available at: www.statnews.com/2021/05/30/if-the-fda-approves-biogens-alzheimers-treatment-i-wont-prescribe-it/ (accessed July 8, 2021).Google Scholar

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