Utility of biomarkers in drug development and approval;Biomarqueurs: Utilisation au cours du développement et pour l'enregistrement des médicaments

Therapie

Volumn , Issue 4, 2001, Pages 355-361

  Gueyffier, F ^a   Dib, M ^a   Boissel, J P ^a   Bensimon, Gilbert ^b   Bohler, Marie Christine ^b   Boissel, Jean Pierre ^b   Boudjadja, Azzedine ^b   Bourin, Michel ^b   Chauvenet, Marina ^b   Calvo, Fabien ^b   Riffaud, Philippe Chaumet ^b   Chêne, Geneviève ^b   Dib, Michel ^b   Diquet, Bertrand ^b   Grima, Michèle ^b   Gneyffier, François ^b   Kadi, Amin ^b   Mariotte, Olivier ^b   Mismetti, Patrick ^b   Paintaud, Gilles ^b   Ravoire, Sophie ^b   more..

^a UNIVERSITÉ LYON 1   (France)

^b NONE

Author keywords

Biomarkers; Drug development; Responders; Therapeutic model

Indexed keywords

ANTIRETROVIRUS AGENT; ZIDOVUDINE; BIOLOGICAL MARKER;

ACQUIRED IMMUNE DEFICIENCY SYNDROME; CONFERENCE PAPER; DRUG APPROVAL; DRUG CHOICE; EVIDENCE BASED MEDICINE; HUMAN; HUMAN IMMUNODEFICIENCY VIRUS INFECTION; MODEL; PRESCRIPTION; PRIORITY JOURNAL; PROGNOSIS; ARTICLE; BIOASSAY; BIOLOGICAL MODEL; CLINICAL TRIAL; DIAGNOSIS RELATED GROUP; DRUG DESIGN; DRUG SCREENING; METHODOLOGY; STANDARD; TREATMENT OUTCOME;

BIOLOGICAL MARKERS; CLINICAL TRIALS; DIAGNOSIS-RELATED GROUPS; DRUG APPROVAL; DRUG DESIGN; DRUG EVALUATION; ENDPOINT DETERMINATION; HUMANS; MODELS, BIOLOGICAL; PROGNOSIS; TREATMENT OUTCOME;

EID: 0034741193     PISSN: 00405957     EISSN: None     Source Type: Journal    
DOI: None     Document Type: Conference Paper

References (25)

1. http://www4.od.nih.gov/biomarkers/
2. Boissel JP, Perret L, Bouvenot G et al. et les membres de la Table Ronde no 2 de Giens XII. Evaluation clinique: du critère intermédiaire au critère de substitution. Therapie 1997; 52: 281-285.
3. Bensimon G, Lacomblez L, Meininger V and the ALS/ Riluzole Study Group. A controlled trial of riluzole in amyotrophic lateral sclerosis. N Engl J Med 1994; 330: 585-591.
4. Lacomblez L, Bensimon G, Nigel Leigh P et al. for the Amyotrophic Lateral Sclerosis/Riluzole Study Group I. Dose-ranging study of riluzole in amyotrophic lateral sclerosis. Lancet 1996; 317: 1425-1431.
5. Montaner JSG, Hogg R, Raboud J et al Antiretroviral treatment in 1998. Lancet 1998; 352: 1919-1922.
6. Garg R, Yusuf S. Overview of randomized trials of angiotensin-converting enzyme inhibitors on mortality and morbidity in patients with heart failure. Collaborative Group on ACE Inhibitor Trials. JAMA 1995; 273: 1450-1456.
7. ISIS-4 (Fourth International Study of Infarct Survival) Collaborative Group - SIS-4: A randomised factorial trial assessing early oral captopril, oral mononitrate, and intravenous magnesium sulphate in 58 050 patients with suspected acute myocardial infarction. Lancet 1995; 345: 669-685.
8. The Heart Outcomes Prevention Evaluation Study Investigators. Effects of in angiotensin-converting-enzyme inhibitor, ramipril, on cardiovascular events in high-risk patients. N Engl J Med 2000; 342: 145-153.
9. Pitt B, Zannad F, Remme WJ et al, for the Randomized Aldactone Evaluation Study investigators. The effect of spironolactone on morbidity and mortality in patients with severe heart failure. N Engl J Med 1999; 341: 709-717.
10. Opal SM. Clinical trials of novel therapeutic agents: why did they fail? In: Vincent-Springer JL, ed. Yearbook of Intensive Care and Emergency Medicine. 1995.
11. Abraham E. Why immunomodulatory therapies have not worked in sepsis. Intensive Care Med 1999; 25: 556-566.
12. Finch RG. Design of clinical trials in sepsis: problems and pitfalls. J Antimicrob Chemother 1998; 41(Suppl. A) 95-102.
13. Andreasen N, Minthen L, Vanmechelen E, et al. Cerebrospinal fluid tau and Abeta42 as predictors of development of Alzheimer's disease in patients with mild cognitive impairment, Neurosci 1999; 273: 5-8.
14. Beta-Blocker Pooling Project Research Group. The Betablocker Pooling Project (BBPP): subgroup findings from randomized trials in post infarction patients. Eur Heart J 1988; 9: 8-16.
15. ISIS 2 (Second International Study of Infarct Survival) collaborative group. Randomized trial of intravenous streptokinasc, oral aspirin, both or neither among 17 187 cases of suspected acute myocardial infarction: ISIS 2. Lancet 1988; ii: 349-360.
16. Joint European Society of Cardiology/American College of Cardiology Committee for the Redefinition of Myocardial Infarction. Myocardial infarction redefined (a consensus document). Eur Heart J 2000; 21: 1502-1513.
17. Heeschen C, Hamm CW, Goldmann B et al. for the PRISM study investigators. Troponin concentrations for stratification of patients with acute coronary syndromes in relation to therapeutic efficacy of tirofiban. Lancet 1999; 354: 1757-1702.
18. Hamm CW, Heeschen C, Goldmann B el al Benefit of abciximab in patients with refractory unstable angina in relation to serum troponin I levels. N Engl J Med 1999; 340: 1623-1629.
19. Batiuk TD, Kung L, Halloran PF. Evidence that calcineurin is rate-limiting for primary human lymphocyte activation. J Clin invest 1997; 100: 1894-1901.
20. Batiuk TD, Pazderka F, Enns J et al. Cyclosporine inhibition of calcineurine activity in human leukocytes in vivo is rapidly reversible. J Clin Invest 1995; 96: 1254-1260.
21. Grima M, Ingert C, Michel B et al. Renal tissue angiotensins during converting enzyme inhibition in the spontaneously hypertensive rat. Clin Exper Hypertension 1997; 19: 671-685.
22. Prentice RL. Surrogate endpoints in clinical trials: definition and operational criteria. Stat Med 1989; 8(4): 431-440.
23. Pulmonary Embolism Prevention (PEP) Trial Collaborative Group. Prevention of pulmonary embolism and deep vein thrombosis with low dose aspirin: Pulmonary Embolism Prevention (PEP) trial. Lancet 2000; 355: 1295-1302.
24. O'Brien WA, Hartigan P, Martin D et al. Veterans Affairs Cooperative Study Group on AIDS. Changes in plasma HIV-1 RNA and CD4+ lymphocyte counts and the risk of progression to AIDS. N Engl J Med 1996; 334: 426-431.
25. Boissel JP, Gueyffier F. Is the isotropy hypothesis true in hypertension? Findings from the INDANA data base. Control Clin Trials 1998; 19(suppl. 3S): 85S-86S.