Approach to the state of the art of data monitoring committees in clinical trials
Keywords:
data monitoring committee, clinical trial, good clinical practices.Abstract
Introduction: For the first time, in 1967, a data monitoring committee was established in a study of cardiovascular mortality. Since then its use has increased, due to its value to guarantee the safety of subjects participating in clinical trials, the validity and integrity of the data. A documentary exploration of the last 20 years was carried out, on aspects related to the requirements for the creation and operation of data monitoring committees worldwide, with the aim of showing the development achieved in the establishment of data monitoring committees and identify its fundamental characteristics.Development: There is an increase in documentary production on data monitoring committees, led by English speakers from developed countries, with a clear increase in publications on the subject, in the last five-year period, 50% higher than in the previous 15 years. This phenomenon is caused by the rise of the pharmaceutical and biotechnology industry, the high costs of drug research and development, the need to introduce new drugs and the increase in regulatory requirements. The structural characteristics, clinical and methodological requirements for the establishment of the committees are described.
Conclusions: There is a high development of data monitoring committees in clinical trials, with a tendency to increase their use in recent years. Data monitoring committees are characterized by clinical and methodological requirements for their establishment.
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References
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20. Food and Drug Administration. Guidance for clinical trial sponsors: establishment and operation of clinical trial Data Monitoring Committees. Washington: FDA; 2006 [acceso: 18/05/2018]. Disponible en: https://www.gmp-compliace.org/guidemgr/files/clindatmon.pdf
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28. Hicks LK, Laupacis A, Slutsky AS. A primer on data safety monitoring boards: mission, methods, and controversies. Intensive Care Med. 2007 [acceso:08/01/2020]; 33:1815-18. Disponibleen: https://link.springer.com/content/pdf/10.1007/s00134-007-0794-9.pdf
29. Defazio A. How to do A/B testing with early stopping correctly.Nueva York: AaronDefazio. Julio 25, 2016 [acceso: 21/09/2018]. Disponibleen: https://www.aarondefazio.com/adefazio-seqtesting.pdf
30. Bassler D, Montori VM, Briel M, Glasziou P, Guyatt G. Early stopping of randomized clinical trials for overt efficacy is problematic. J ClinEpidemiol. 2008;61(3):241-6. Disponible en: https://citeseerx.ist.psu.edu/viewdoc/download?doi=10.1.1.662-.921&rep=rep1&type=pdf
31. CTSA Collaborative DSMB Workgroup. DSMB Training Manual. Medford: Tufts Digital Library; 2018 [acceso:05/08/2019]. Disponible en: https://ctscweb.weill.cornell.edu/sites/default/files/24992.archival.pdf
32. Calis KA, Archdeacon P, Bain R, DeMets DL, Donohue M, Elzarrad MK, et al. Recommendations for data monitoring committees from the clinical trials Transformation initiative. ClinicalTrials. 2017 [acceso: 18/05/2018]; 14(4):342-48. Disponible en: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5639979/pdf/10.1177-_1740774517707743.pdf
2. Centro para el Control Estatal de Medicamentos, Equipos y Dispositivos Médicos. Directrices sobre Buenas Prácticas Clínicas en Cuba. La Habana: CECMED; 2000. [acceso: 25/06/2018]. Disponible en: https://www.cecmed.cu/sites/default/files/adjuntos/Reglamentacion/-Dir_BPC.pdf
3. United States Department of Health and Human Services Food and Drug Administration. E6 (R2) Good Clinical Practice: Integrated Addendum to ICHE6 (R1) Guidance for Industry. Washington: FDA; 2018.[acceso: 25/06/2018]. Disponible en: https://www.fda.gov/downloads/Drugs/Guidances/UCM464506.pdf
4. Laporte JR. Principios básicos de investigación clínica. Barcelona: AstraZeneca;2001.[acceso: 23/03/2018]. Disponible en: https://files.sld.cu/cdfc/files/2010/02/principios_basicos_inv_clin.pdf
5. Ellenberg S, Fernandes RM, Saloojee H, Bassler D, Askie L, Vandermeer B, et al. Data Monitoring Committees. Pediatrics. 2012 [acceso: 16/11/2017];129(3):[aprox. 4 p.]. Disponible en: https://pediatrics.aappublications.org/content/129/Supplement_3/S132/
6. Calis KA, Archdeacon P, Bain RP, Forrest A, Perlmutter J, DeMets DL. Understanding the functions and operations of data monitoring committees: Survey and focus group findings. Clinical Trials. 2017 [acceso: 18/05/2018];14(1):[aprox. 7 p.]. Disponible en: https://www.researchgate.net/publication/310813158_Understanding_-the_functions_and_operations_of_data_monitoring_committee_Survey-_and_focus_group_findings/fulltext/5a185cffa6fdcc50ade7e13f/-Understanding-the-functions-and-operations-of-data-monitoring-committee-Survey-and-focus-group-findings.pdf
7. O'Neill RT. Regulatory perspectives on data monitoring. Statist Med. 2002 [acceso: 25/06/2018];21:[aprox. 5 p.]. Disponible en: https://onlinelibrary.wiley.com/doi/epdf/10.1002/sim.1287
8. Seltzer J. An estimate of the benefit-cost impact of the FDA guidance on Data Monitoring Committees. Ther Innov Regul Sci. 2015 [acceso: 14/05/2018];49(5):[aprox 9 p.]. Disponible en: https://journals.sagepub.com/doi/abs/10.1177/2168479015573586
9. Pinheiro J. Regulatory guidance documents on adaptive designs: an industry perspective. In: He W, Pinheiro J, Kusnetsova O (eds). Practical Considerations for Adaptative Trial Design and Implementation. Statistics for Biology and Health. Springer, New York, NY; 2014 [acceso: 10/05/2018]. Disponible en: https://www.researchgate.net/publication/301951332_Regulatory-_Guidance_Dcuments_on_Adaptative_Desigs_An_Industr_Perspective
10. Lewis RJ, Calis KA, DeMets DL. Enhancing the scientific integrity and safety of clinical trials. Recommendations for Data Monitoring Committees. JAMA. 2016 [acceso: 16/11/2017];316(22):2359-60. Disponible en: https://pubmed.ncbi.nlm.nih.gov/27960001/
11. Sánchez G. Investigación clínica en seres humanos en Colombia ¿Estamos en crisis? Acta Med Colomb. 2017 [acceso: 24/04/2019];42(4):[aprox. 5 p.]. Disponible en: https://www.scielo.org.co/pdf/amc/v42n4/0120-2448-amc-42-04-00207.pdf
12. Ellenberg SS, Fleming TR, DeMets DL. Data Monitoring Committees in clinical trials: a practical perspective. 2nd ed. Southern Gate (England): John Wiley & Sons; 2019. [acceso:05/08/2019]. Disponible en: https://93.174.95.29/_ads/B8971AC4CE00890D8EDD1CA1CF98DAFD
13. Molina de Salazar DI, Botero SM, Giraldo Manizales GC. Investigación clínica y ensayos clínicos ¿En qué vamos? Acta Médica Colombiana. 2016 [acceso: 12/04/2019];42(4):[aprox. 5 p.]. Disponible en: https://www.scielo.org.co/pdf/amc/v42n4/0120-2448-amc-42-04-00207.pdf
14. Bierer BE, Li R, Seltzer J, Sleeper LA, Frank E, Knirsch C, et al. Responsibilities of Data Monitoring Committees: consensus recommendations. Ther Innov Regul Sci. 2016[acceso: 13/07/2018];50(5):648-659. DOI: 10.1177/2168479016646812
15. Canadian Cancer Trials Group. Policies for the Data Safety Monitoring Committee. Toronto: CCTG; 2017. [acceso 27/04/2019]. Disponible en: https://www.ctg.queensu.ca/docs/public/committees/Policiesforthe-DataSafetyMonitoringCommittee.pdf
16. DEMOCLES Study Group. A proposed charter for clinical trial Data Monitoring Committees: helping them to do their job well. Lancet. 2005 [acceso: 25/06/2018];365(9460):711-22. Disponibleen: https://doi.org/10.1016/S0140-6736(05)17965-3
17. Past SOCRA source articles. Duke: SOCRA;2003 [actualizado: 2003; acceso: 18/05/2018].The role of Data Monitoring Committees and their impact on Clinical Research Associate Responsabilities [aprox. 9 pant.]. Disponible en: https://www.socra.org/publications/past-socra-source-articles/the-role-of-data-monitoring-committees-and-their-impact-on-clinical-research-associate-responsabilities/
18. Gates A, Caldwell P, Curtis S, Dans L, Fernandez RM, Hartling L, et al. Reporting of data monitoring committees and adverse events in pediatric trials: a descriptive analysis. BMJ. 2019 [acceso: 27/04/2019];3:[aprox. 8 p.]. Disponible en: https://bmjpaedsopen.bmj.com/content/bmjpo/3/1/e000426.full.pdf
19. Borg-Debono V, Mbuagbaw L, Thabane L. Sharing interim trial results by the Data Safety Monitoring Board with those responsible for the trial's conduct and progress: a narrative review. CanadaTrials. 2017 [acceso: 18/05/2018]; 18:120. [aprox. 13 p.].Disponible en: https://trialsjournal.biomedcentral.com/articles/10.1186/s13063-017-1858-y
20. Food and Drug Administration. Guidance for clinical trial sponsors: establishment and operation of clinical trial Data Monitoring Committees. Washington: FDA; 2006 [acceso: 18/05/2018]. Disponible en: https://www.gmp-compliace.org/guidemgr/files/clindatmon.pdf
21. European Medicines Agency. Guideline on data monitoring committees. In: Committee for medicinal products for human use.London: EMA; 2005[acceso: 17/01/2018]. Disponible en: https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-data-monitoring-committees_en.pdf
22. National Health and Medical Research Council. Data Safety Monitoring Boards (DSMBs). Sidney: NHMRC; 2018 [acceso: 25/06/2018]. Disponible en: https://www.australianclinicaltrials.gov.au/sites/default/file/content/for research/data_safety_monitoring_boards_1.pdf
23. Ando Y. Guidance on Data Monitoring Committee: regulatory perspective in Japan. En: Austria-Japan Joint Statistics Workshop. Data monitoring committees in clinical trials. Viena; 25/03/2015.[acceso 13/07/2018]. Disponible en: https://www.pmda.go.jp/files/000204620.pdf
24. Turkish Medicine and Medical Device Agency. Guidelines regarding Independent Data Monitoring Committees. Istanbul: Turkish Medicine and Medical Device Agency; 2013 [acceso: 13/07/2018]. Disponibleen: https://es.slideshare.net/anova83/guidelines-regarding-independent-data-monitoring-committeesapril2013
25. Special Programmer for Research and Training in Tropical Diseases. Operational guidelines for the establishment and functioning of Data and Safety Monitoring Boards. Geneva: WHO; 2005 [acceso: 13/07/2018]. Disponible en: https://www.who.int/tdr/publications/documents/operational-guidelines.pdf
26. U.S. Department of Health and Human Services. NIH:National Institute of Arthritis and Musculoskeletal and Skin Diseases. Bethesda, Maryland; 2017. Data and Safety Monitoring (DSM) Guidelines. [actualizado: 08/01/2017; acceso: 20/02/2019] [aprox. 11 pant.]. Disponible en: https://www.niams.nih.gov/grants-funding/data-safety-monitoring/dsm-guidelines
27. Sartor O, Halabi S. Independent Data Monitoring Committees: An Update and Overview. UrolOncol. 2015 [acceso: 14/01/2020]; 33(3):143-8. Disponible en https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4516383/
28. Hicks LK, Laupacis A, Slutsky AS. A primer on data safety monitoring boards: mission, methods, and controversies. Intensive Care Med. 2007 [acceso:08/01/2020]; 33:1815-18. Disponibleen: https://link.springer.com/content/pdf/10.1007/s00134-007-0794-9.pdf
29. Defazio A. How to do A/B testing with early stopping correctly.Nueva York: AaronDefazio. Julio 25, 2016 [acceso: 21/09/2018]. Disponibleen: https://www.aarondefazio.com/adefazio-seqtesting.pdf
30. Bassler D, Montori VM, Briel M, Glasziou P, Guyatt G. Early stopping of randomized clinical trials for overt efficacy is problematic. J ClinEpidemiol. 2008;61(3):241-6. Disponible en: https://citeseerx.ist.psu.edu/viewdoc/download?doi=10.1.1.662-.921&rep=rep1&type=pdf
31. CTSA Collaborative DSMB Workgroup. DSMB Training Manual. Medford: Tufts Digital Library; 2018 [acceso:05/08/2019]. Disponible en: https://ctscweb.weill.cornell.edu/sites/default/files/24992.archival.pdf
32. Calis KA, Archdeacon P, Bain R, DeMets DL, Donohue M, Elzarrad MK, et al. Recommendations for data monitoring committees from the clinical trials Transformation initiative. ClinicalTrials. 2017 [acceso: 18/05/2018]; 14(4):342-48. Disponible en: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5639979/pdf/10.1177-_1740774517707743.pdf
Published
2021-01-01
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Pérez Rodríguez S, Lara Fernández HL, Arteaga Cantón S, Rodríguez González M de la C, Tamayo Rodríguez M. Approach to the state of the art of data monitoring committees in clinical trials. Rev Cubana Med Milit [Internet]. 2021 Jan. 1 [cited 2025 Jul. 6];50(1):e0210529. Available from: https://revmedmilitar.sld.cu/index.php/mil/article/view/529
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