Driving earlier clinical attrition: if you want to find the needle, burn down the haystack. Considerations for biomarker development

Drug Discovery Today

Volumn 12, Issue 7-8, 2007, Pages 289-294

  Peck, Richard W ^a  

^a ELI LILLY AND COMPANY   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

ALANINE AMINOTRANSFERASE; ANTIVIRUS AGENT; ASPARTATE AMINOTRANSFERASE; BETA 1 ADRENERGIC RECEPTOR BLOCKING AGENT; BIOLOGICAL MARKER; CANNABINOID 1 RECEPTOR; CANNABINOID CB1 RECEPTOR ANTAGONIST; GROWTH HORMONE; ISOPRENALINE; KETANSERIN; RECEPTOR BLOCKING AGENT; SIBUTRAMINE; UNCLASSIFIED DRUG; ZOLMITRIPTAN;

ACCURACY; BIOASSAY; COST BENEFIT ANALYSIS; COST CONTROL; DISEASE MARKER; DRUG EFFICACY; DRUG INDUSTRY; DRUG RESEARCH; DRUG SAFETY; EVALUATION; HUMAN; PREDICTION; REPRODUCIBILITY; REVIEW; SENSITIVITY AND SPECIFICITY; VALIDATION PROCESS;

BIOLOGICAL MARKERS; CLINICAL TRIALS; DRUG DESIGN; DRUG INDUSTRY; HUMANS; MODELS, THEORETICAL; RESEARCH;

EID: 33947691728     PISSN: 13596446     EISSN: None     Source Type: Journal    
DOI: 10.1016/j.drudis.2007.02.004     Document Type: Review

References (24)

1. Schmid E.F., and Smith D.A. Is declining innovation in the pharmaceutical industry a myth?. Drug Discov. Today 10 (2005) 1031-1039
2. C.M.R International. 2006/7 Pharmaceutical R&D Factbook (2006), CMR International
3. DiMasi J.A., et al. The price of innovation: new estimates of drug development costs. J. Health Econ. 22 (2003) 151-185
4. Berenson, A. (2006) Drugs in '05: Much promise, little payoff; just 20 new products approved despite biotechnology's hope. New York Times 11 January, p. 1
5. DiMasi J.A. The value of improving the productivity of the drug development process. Faster times and better decisions. Pharmacoeconomics 20 Suppl 3 (2002) 1-10
6. Kola I., and Landis J. Can the pharmaceutical industry reduce attrition rates? Nat. Rev. Drug Discov. 3 (2004) 711-715
7. DiMasi J.A. Risks in new drug development: approval success rates for investigational drugs. Clin. Pharmacol. Ther. 69 (2001) 297-307
8. Biomarkers Definitions Working Group. Biomarkers and surrogate endpoints: preferred definitions and conceptual framework. Clin. Pharmacol. Ther. 69 (2001) 89-95
9. Jawad S., et al. The effect of lamotrigine, a novel anticonvulsant, on interictal spikes in patients with epilepsy. Br. J. Clin. Pharmacol. 22 (1986) 191-193
10. Binnie C.D., et al. Acute effects of lamotrigine (BW430C) in persons with epilepsy. Epilepsia 27 (1986) 248-254
11. Peck A.W. Lamotrigine: historical background. Rev. Contemp. Pharmacother. 5 (1994) 95-105
12. Fleming T.R., and DeMets D.L. Surrogate endpoints in clinical trials, are we being misled? Ann. Intern. Med. 125 (1996) 605-613
13. Rolan P. The contribution of clinical pharmacology surrogates and models to drug development - a critical appraisal. Br. J. Clin. Pharmacol. 44 (1997) 219-225
14. 1D receptors?. Psychopharmacology (Berl.) 145 (1999) 223-226
15. Vanmolkot F.H., et al. Non-invasive assessment of selective 5-HT(1B/1D) receptor agonist induced peripheral vascular effects in humans: comparison of different techniques. Eur. J. Clin. Pharmacol. 58 (2002) 303-308
16. Purkins L., et al. The influence of diet upon liver function tests and serum lipids in healthy male volunteers resident in a Phase I unit. Br. J. Clin. Pharmacol. 57 (2004) 199-208
17. Sim J., and Arnell P. Measurement validity in physical therapy research. Phys. Ther. 73 (1993) 102-115
18. Arnold J.M., and McDevitt D.G. Heart rate and blood pressure responses to intravenous boluses of isoprenaline in the presence of propranolol, practolol and atropine. Br. J. Clin. Pharmacol. 16 (1983) 175-184
19. Layden J.E., and Layden T.J. Viral kinetics of hepatitis C: new insights and remaining limitations. Hepatology 35 (2002) 967-970
20. Santucci V., et al. Arousal-enhancing properties of the CB1 cannabinoid receptor antagonist SR 141716A in rats as assessed by electroencephalographic spectral and sleep-waking cycle analysis. Life Sci. 58 (1996) PL103-PL110
21. Bray G.A., et al. Sibutramine - dose response and long term efficacy in weight loss, a double-blind study. Int. J. Obes. 20 (1996) 147-153
22. Rolls B.J., et al. Sibutramine reduces food intake in non-dieting women with obesity. Obes. Res. 6 (1998) 1-11
23. Chapelot D., et al. Modalities of food intake-reducing effect of sibutramine in humans. Physiol. Behav. 68 (2000) 299-308
24. Jackson H.C., et al. Comparison of the effects of sibutramine and other monoamine reuptake inhibitors on food intake in the rat. Br. J. Pharmacol. 121 (1997) 1758-1762