Les DSMB : 1. Quel rôle, quelles responsabilités ?

Christian Brun-Buisson

doi:10.1051/medsci/200521178

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Volume 21 / Numéro 1 (Janvier 2005)

Med Sci (Paris), 21 1 (2005) 78-82

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Numéro		Med Sci (Paris) Volume 21, Numéro 1, Janvier 2005


Page(s)		78 - 82
Section		M/S Revues
DOI		https://doi.org/10.1051/medsci/200521178
Publié en ligne		15 janvier 2005

US department of health and human services. Food and drug administration. Draft guidance for clinical trials sponsors. On the establishment and operation of clinical trials data monitoring committees. Novembre 2001. http://www.fda.gov/cber/gdlns/clindatmon.htm [Google Scholar]
Armstrong PW, Furberg CD. Clinical trial data and safety monitoring boards. The search for a constitution. Circulation 1995; 91 : 901–4. [Google Scholar]
DeMets DL, Pocock SJ, Julian DG. The agonising negative trend in monitoring of clinical trials. Lancet 1999; 354 : 1983–8. [Google Scholar]
Lemaire F, Brun-Buisson C. Are institutional review boards effective in safeguarding patients in intensive care units ? Curr Opin Anaesthesiol 2000; 13 : 195–201. [Google Scholar]
Morse MA, Califf RM, Sugarman J. Monitoring and ensuring safety during clinical research. JAMA 2001; 285 : 1201–5. [Google Scholar]
Mello MM, Studdert DM, Brennan TA. The rise of litigation in human subjects research. Ann Intern Med 2003; 139 : 40–5. [Google Scholar]
Kalb PE, Koehler KG. Legal issues in scientific research. JAMA 2002; 287 : 85–91. [Google Scholar]
McCloskey RV, Straube RC, Sanders C, et al. The CHESS trial study group. Treatment of septic shock with human monoclonal antibody HA-1A. A randomized, double-blind, placebo-controlled trial. Ann Intern Med 1994; 121 : 1–5. [Google Scholar]
Wolkenstein P, Latarjet J, Roujeau JC, et al. Randomised comparison of thalidomide versus placebo in toxic epidermal necrolysis. Lancet 1998; 352 : 1586–9. [Google Scholar]
Brun-Buisson C. Les DSMB. 2. De l’importance d’un DSMB efficace : exemples d’essais cliniques « à risque ». Med Sci (Paris) 2005; 1 (sous presse). [Google Scholar]
Slutsky AS, Lavery JV. Data safety and monitoring boards. N Engl J Med 2004; 350 : 1143–7. [Google Scholar]
Pocock S, White I. Trials stopped early : too good to be true ? Lancet 1999; 353 : 943–4. [Google Scholar]
Bernard GR, Vincent JL, Laterre PF, et al. Efficacy and safety of recombinant human activated protein C for severe sepsis. N Engl J Med 2001; 344 : 699–709. [Google Scholar]

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[1] US department of health and human services. Food and drug administration. Draft guidance for clinical trials sponsors. On the establishment and operation of clinical trials data monitoring committees. Novembre 2001. http://www.fda.gov/cber/gdlns/clindatmon.htm [Google Scholar]

[2] Armstrong PW, Furberg CD. Clinical trial data and safety monitoring boards. The search for a constitution. Circulation 1995; 91 : 901–4. [Google Scholar]

[3] DeMets DL, Pocock SJ, Julian DG. The agonising negative trend in monitoring of clinical trials. Lancet 1999; 354 : 1983–8. [Google Scholar]

[4] Lemaire F, Brun-Buisson C. Are institutional review boards effective in safeguarding patients in intensive care units ? Curr Opin Anaesthesiol 2000; 13 : 195–201. [Google Scholar]

[5] Morse MA, Califf RM, Sugarman J. Monitoring and ensuring safety during clinical research. JAMA 2001; 285 : 1201–5. [Google Scholar]

[6] Mello MM, Studdert DM, Brennan TA. The rise of litigation in human subjects research. Ann Intern Med 2003; 139 : 40–5. [Google Scholar]

[7] Kalb PE, Koehler KG. Legal issues in scientific research. JAMA 2002; 287 : 85–91. [Google Scholar]

[8] McCloskey RV, Straube RC, Sanders C, et al. The CHESS trial study group. Treatment of septic shock with human monoclonal antibody HA-1A. A randomized, double-blind, placebo-controlled trial. Ann Intern Med 1994; 121 : 1–5. [Google Scholar]

[9] Wolkenstein P, Latarjet J, Roujeau JC, et al. Randomised comparison of thalidomide versus placebo in toxic epidermal necrolysis. Lancet 1998; 352 : 1586–9. [Google Scholar]

[10] Brun-Buisson C. Les DSMB. 2. De l’importance d’un DSMB efficace : exemples d’essais cliniques « à risque ». Med Sci (Paris) 2005; 1 (sous presse). [Google Scholar]

[11] Slutsky AS, Lavery JV. Data safety and monitoring boards. N Engl J Med 2004; 350 : 1143–7. [Google Scholar]

[12] Pocock S, White I. Trials stopped early : too good to be true ? Lancet 1999; 353 : 943–4. [Google Scholar]

[13] Bernard GR, Vincent JL, Laterre PF, et al. Efficacy and safety of recombinant human activated protein C for severe sepsis. N Engl J Med 2001; 344 : 699–709. [Google Scholar]