medigraphic.com
ISSN 1025-0255 (Electronic)

2015, Number 2

<< Back Next >>

AMC 2015; 19 (2)

Ethics in the design, conduction and monitoring of clinical trials with SURFACEN® in Cuba

Ávila AY, Barrese PY, Morilla GAA, Rodríguez MVS, Lim AN, Díaz CE

Language: Spanish
References: 23
Page: 138-147
PDF size: 922.44 Kb.


ABSTRACT

Background: the Coordinating National Center of Clinical Trial, the National Center of Agricultural Health and the Cuban intensive care units carried out clinical trials with SURFACEN® to treat respiratory distress syndrome.
Objective: to describe the ethical in the design, conduction and monitoring of these clinical trials, as well as determine its internal and external validity.
Methods: a descriptive, prospective study was conducted between 2004 and 2014. Protocols, data collecting notebooks and informed consent were designed; clinical sites, human and material resources were planned; clinical investigators were trained; also, the implementation of clinical trials stages II, III, and IV that evaluated the effect, effectiveness and security of SURFACEN® to treat respiratory distress syndrome in three population groups: newborn babies, infants, children (up to 18 years old) and adults, was monitored.
Results: forty-one intensive care units participated (17 of neonatology, 7 for pediatric patients and 17 for adults), 1 413 patients were evaluated and 306 were included and 709 health professionals were trained in Good Clinical Practice. The performance of the ethical norms for the investigation in human beings could be shown in the monitoring, the revision of the documentation and the carried-out procedures. The internal validity of the results could be shown through the objectivity of the observation, the recurrent comparison and the random assignment of treatments, and through the planning and performance according to the Guides of Good Clinical Practice. The external validity could be shown in the change of the legislation of the product with the approval of three new indications: for the acute respiratory distress syndrome in pediatric patients and adults and for preterm babies with an early use (two hours old).
Conclusions: the design, conduction and monitoring of clinical trials with SURFACEN® performed the basic ethical principles for the clinical investigation and guaranteed the internal and external validity of the results.


REFERENCES

  1. Devereaux PJ, Manns BJ, Ghali WA, Quan H, Guyatt GH. The reporting of methodolog-ical factor in randomized controlled trial and the association with a journal policy to pro-mote adherence to the Consolidated Stand-ards of Reporting Trial (CONSORT). Control Clin Trials. 2012 Aug;23:380-8.

  2. Manzanares Tapia D, Díaz Casañas E, Alfon-so Lorenzo WC, Escobar Medina AC, Colomé Dagnesses H, Muñoz Pérez, MC, et al. Cen-tro Nacional de Sanidad Agropecuaria. Sur-factante pulmonar natural de origen por-cino. Patente de la República de Cuba A61K 35/42. 1997 Dic 24.

  3. Moreno Vázquez O, Lee López M, Domín-guez Dieppa F, Pascual López MA, Alonso Abad A, Jiménez Rivero G, et al. Estudio de la eficacia del Surfacén en el distress respi-ratorio del recién nacido. Rev Cubana Pedi-atr [Internet]. Jun 1999 [citado 14 Ene 2015];71(2):[aprox. 11 p.]. Disponible en: http://scieloprueba.sld.cu/scielo.php?script=sci_arttext&pid=S0034-75311999000200002&lng=es.

  4. Ashbaugh DG, Bigelow DB, Petty TL, Levine BE. Acute respiratory distress in adults. Lancet. 1967 Aug;2(7511):319-23.

  5. Murray JF, Matthay MA, Luce JM, Flick MR. An expanded definition of the adult respira-tory distress syndrome. Am Rev Respir Dis. 1989 Sep;139(4):1065.

  6. Bellingan GJ. The pulmonary physician in critical care: The pathogenesis of ALI/ARDS. Thorax. 2002 Jun;57(6):540-6.

  7. Manteiga Riestra E, Martínez González O, Frutos Vivar F. Epidemiología del daño pul-monar agudo y síndrome de distrés respira-torio agudo. Med. Intensiva. May 2006;30(4):151-161.

  8. Ju-Ming J, Foong T, Testoni D, Guan J, Hui Y, Hau J. Epidemiology of pediatric acute respiratory distress syndrome in Singapore: risk factors and predictive respiratory indi-ces of mortality. F Ped. 2014 Jul;2:1-6.

  9. Bernard GR, Artigas A, Brigham KL, Carlet J, Falke K, Hudson L, et al. The American-European Consensus Conference on ARDS. Definitions, mechanisms, relevant out-comes, and clinical trial coordination. Am J Respir Crit Care Med. 1994 Mar;149(3 Pt 1):818-24.

  10. Dahlem P, Van Aalderen WM, Bos AP. Pedi-atric acute lung injury. Paediatr Respir Rev. 2007 Dec; 8(4):348-62.

  11. Hidalgo OA, Barrese Pérez Y, Díaz Casañas E, Uranga Piña R, Fernández Limia O, Avila Albuerne Y, et al. Informe final del ensayo clínico fase II Evaluación de la eficacia y la seguridad del SURFACEN en el tratamiento del Síndrome de Distress Respiratorio Agu-do en el Adulto. La Habana, Cuba: MINSAP; May 2011.

  12. Morilla Guzmán A, Barrese Pérez Y, Díaz Casañas E, Uranga Piña R, Avila Albuerne Y, et al. Informe final del ensayo clínico fa-se IV Evaluación de la efectividad y segu-ridad del uso temprano del SURFACEN en recién nacidos pretérminos con Síndrome de Distress Respiratorio. La Habana, Cuba: MINSAP; Nov 2013.

  13. Rodríguez Moya VS, Barrese Pérez Y, Díaz Casañas E, Uranga Piña R, Avila Albuerne Y, Blanco Hidalgo O, et al. Informe final del ensayo clínico fase III Evaluación de la efi-cacia y la seguridad del SURFACEN en el tratamiento del Síndrome de Distress Res-piratorio Agudo en edades pediátricas. La Habana, Cuba: MINSAP; Abr 2014.

  14. Centro para el Control Estatal de los Medi-camentos, Equipos y Dispositivos Médicos. Ministerio de Salud Pública de Cuba. Direc-trices sobre Buenas Prácticas Clínicas en Cuba. La Habana, Cuba: ECIMED; 2000 consultado 8 Ago 2014. Disponible en: http://www.cecmed.cu/Pages/Reg_DispGen.htm

  15. Asociación médica mundial. Declaración de Helsinki. Principios éticos para las investi-gaciones médicas en seres humanos consultado 8 Ago 2014. Disponible en: http://www.wma.net

  16. Morilla Guzmán AA, Tamayo Pérez VI, Carro Puig E, Fernández Braojos LS. Enfermedad de la membrana hialina en Cuba. Rev Cu-bana Pediatr [Internet]. Jun 2007 [citado 13 Ene 2015];79(2):[aprox. 12 p.]. Dispo-nible en: http://scieloprueba.sld.cu/scielo.php?script=sci_arttext&pid=S0034-75312007000200008&lng=es.

  17. Ministerio de Salud Pública. Dirección Na-cional de Estadísticas. Registro de morbili-dad continúa. Servicios cerrados de Neona-tología. 2008-2012. La Habana (Cuba): Ofi-cina Nacional de Estadísticas del MINSAP; 2008-2012.

  18. Willson DF, Thomas NJ, Markovitz BP, Bau-man LA, DiCarlo JV, Pon S, et al. Effect of exogenous surfactant (calfactant) in pediat-ric acute lung injury: a randomized con-trolled trial. JAMA. 2005 Jan 26;293(4):470-476.

  19. Raghavendran K, Willson D, Notter RH. Surfactant Therapy of ALI and ARDS. Crit Care Clin. 2011 Jul 1;27(3):525–59.

  20. Tortorolo L, Chiaretti A, Pulitanò S, Genovese O, Conti G. Diluted porcine surfactant lung lavages in children with severe ARDS. Signa Vitae. 2009;4(2):16-9.

  21. Guerin C, Debord S, Leray V, Delannoy B, Bayle F, Bourdin G. Efficacy and safety of recruitment maneuvers in acute respiratory distress syndrome. Annals of Intensive Care. 2011;1:9.

  22. Barreto S, Bejarano L. Características epi-demiológicas y sobrevida de RN de muy bajo peso al nacer tratados con ventilación mecánica. Rev Hosp Mat Inf Ramón Sardá [Internet]. 2010 [citado 12 Oct 2011];29(2):[aprox. 10 p.]. Disponible en: http://www.redalyc.org/articulo.oa?id=91213730002

  23. Zahle Oestergaard M, Inoue M, Yoshida S, Retno Mahanani W, Gore FM, Cousens S, et al, United Nations Inter-agency Group for Child Mortality Estimation y the Child Health Epidemiology Reference Group. Neo-natal Mortality Levels for 193 Countries in 2009 with Trends since 1990: A Systematic Analysis of Progress, Projections, and Prior-ities. PLoS Med. 2011;8(8):23-34.




2020     |     www.medigraphic.com