Regulatory perspectives on clinical trials for trauma, transfusion, and hemostasis

Transfusion

Volumn 45, Issue SUPPL. 1, 2005, Pages

  Silverman, Toby ^a   Aebersold, Paul ^a   Landow, Laurence ^a   Lindsey, Kimberly ^a  

^a CENTER FOR BIOLOGICS EVALUATION AND RESEARCH   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

FIBRIN GLUE; FIBRINOGEN; NEW DRUG; SEALANT; THROMBIN;

BLOOD BANK; BLOOD TRANSFUSION; CLINICAL TRIAL; COMORBIDITY; CONFERENCE PAPER; CONSULTATION; DEVICE; ETHICS; HEMOSTASIS; HUMAN; INJURY; OXYGENATION; QUALITY CONTROL; RISK BENEFIT ANALYSIS;

BLOOD TRANSFUSION; CLINICAL TRIALS; GUIDELINES; HEMOSTATIC TECHNIQUES; HUMANS; UNITED STATES; UNITED STATES FOOD AND DRUG ADMINISTRATION; WOUNDS AND INJURIES;

EID: 21644454396     PISSN: 00411132     EISSN: None     Source Type: Journal    
DOI: 10.1111/j.0041-1132.2005.00157.x     Document Type: Conference Paper

References (21)

1. United States Code, Title 21, Chapter 9, Federal Food, Drug, and Cosmetic Act.
2. Guidance for industry, providing clinical evidence of effectiveness for human drugs and biological products [Internet]. Rockville: U.S. Food and Drug Administration, Center for Biologies Evaluation and Research; 1998 May. Available at: http://www.fda.gov/cber/guidelines.htm
3. Code of Federal Regulations, 21 C.F.R. Sect 314.26.
4. Meinert CL. Clinical trials: design, conduct, and analysis. New York: Oxford University Press; 1986. p. 304.
5. Temple RJ. A Regulatory authority's opinion about surrogate endpoints in clinical measurement in drug evaluation. New York: Wiley; 1995. p. 3-22.
6. Friedman LM, Furberg CD, DeMets DL. Fundamentals of clinical trials. 3rd ed. St. Louis: Mosby-Year Book; 1996. p. 24-6.
7. Moore FA, McKinley BA, Moore EE. The next generation in shock resuscitation. Lancet 2004;363:1988-96.
8. Sloan EP, Koenigsberg M, Gens D, et al. Diaspirin cross-linked hemoglobin (DCLHb) in the treatment of severe traumatic hemorrhagic shock: a randomized controlled efficacy trial. JAMA 1999;282:1857-64.
9. Riou B, Landais P, Vivien B, et al. The distribution of the probability of survival is a strategic issue in randomized trials in critically ill patients. Anesthesiology 2001;95:56-63.
10. Workshop on criteria for safety and efficacy evaluation of oxygen therapeutics as red cell substitutes [Internet]. Bethesda: U.S. Food and Drug Administration, Center for Biologies Evaluation and Research; 1999 Sep 27-28. Available from: http://www.fda.gov/cber/minutes/workshop-min.htm
11. Federal Register documents (October 2,1996) (codified at 61 FR 51497). Bethedsa: U.S. Food and Drug Administration; Available from: http://www.fda.gov
12. The Belmont Report [Internet]. Washington (DC): U.S. Department of Health and Human Services; 1979 Apr 18. Available from: http://www.hhs.gov/ohrp/ humansubjects/ guidance/belmont.htm
13. Weiskopf RB, Viele MK, Feiner J, et al. Human cardiovascular and metabolic response to acute, severe isovolemic anemia. JAMA 1998;279:217-21.
14. Weiskopf RB, Kramer JH, Viele M, et al. Acute severe isovolemic anemia impairs cognitive function and memory in humans. Anesthesiology 2000;92:1646-52.
15. Carson JL, Duff A, Poses RM, et al. Effect of anaemia and cardiovascular disease on surgical mortality and morbidity. Lancet 1996;348:1055-60.
16. Malone DL, Dunne J, Tracy JK, et al. Blood transfusion, independent of shock severity, is a ssociated with worse outcome in trauma. J Trauma 2003;54:898-907.
17. Hebert PC, Wells G, Blajchman MA, et al. A multicenter, randomized, controlled clinical trial of transfusion requirements in critical care. N Engl J Med 1999;340:409-17.
18. Dzik WH. Emily Cooley Lecture 2002: transfusion safety in the hospital. Transfusion 2003;43:1190-9.
19. Buehler PW, Alayash AI. Toxicities of hemoglobin solutions: in search of in-vitro and in-vivo model systems. Transfusion 2004;44:1516-30.
20. Alving BM, Weinstein MJ, Finlayson JS, Menitove JE, Fratantoni JC. Fibrin sealant: summary of a conference on characteristics and clinical uses. Transfusion 1995;35:783-90.
21. Guidance for industry: efficacy studies to support marketing applications of fibrin sealant products manufactured for commercial use [Internet]. Bethesda: U.S. Food and Drug Administration, Center for Biologies Evaluation and Research; 1999 May. Available from: http://www.fda.gov/ cber/guidelines.htm