Benefit-risk analysis: A proposal using quantitative methods

Pharmacoepidemiology and Drug Safety

Volumn 12, Issue 7, 2003, Pages 611-616

  Holden, William L ^a,b   Juhaeri, Juhaeri ^a   Dai, Wanju ^a  

^a SANOFI   (France)

^b Global Pharmacovigilance and Epidemiology   (United States)

Author keywords

Benefit risk analysis; Methods; Minimum clinical efficacy analysis; Number needed to harm; Number needed to treat; Pharmacoepidemiology

Indexed keywords

ANTINEOPLASTIC AGENT;

ARTICLE; BREAST CANCER; DRUG EFFICACY; DRUG INDUSTRY; DRUG LEGISLATION; DRUG SAFETY; DRUG SURVEILLANCE PROGRAM; HUMAN; METHODOLOGY; PATIENT CARE; PHARMACOEPIDEMIOLOGY; PRIORITY JOURNAL; QUANTITATIVE ANALYSIS; RISK ASSESSMENT; RISK BENEFIT ANALYSIS; RISK MANAGEMENT; SIDE EFFECT; THEORETICAL STUDY;

GUIDELINES; HUMANS; PHARMACOEPIDEMIOLOGY; RISK ASSESSMENT;

EID: 0141505916     PISSN: 10538569     EISSN: None     Source Type: Journal    
DOI: 10.1002/pds.887     Document Type: Article

References (20)

1. Cocchetto D, Nardi R. Benefit-risk assessment of investigational drugs: current methodology, limitations, and alternative approaches. Pharmacotherapy 1986; 6: 286-303.
2. Aaron C, Harbach P, Mattano S, et al. Risk and benefit evaluation in development of pharmaceutical products. Environ-Health Perspect 1993; 101(Suppl. 3): 291-295.
3. Rawlins M. Trading risk for benefit. In Risk and Consent to Risk in Medicine, Mann R (ed.). Parthenon Publishing: London, 1989; 193-202.
4. Edwards R, Wiholm B-E, Martinez C. Concepts in risk-benefit assessment. A simple merit analysis of a medicine? Drug Safe 1996; 15: 1-7.
5. CIOMS. Benefit-Risk balance for marketed drugs: evaluating safety signals. Geneva: CIOMS, 1998.
6. Korting H, Schafer-Korting M. (eds). The benefit-risk ratio. A handbook for the rational use of potentially hazardous drugs. CRC Press: Boca Raton, 1999.
7. Ernst E, Resch K. Risk-benefit ratio or risk-benefit nonsense? J Clin Epidemiol 1996; 49: 1203-1204.
8. FDA Task Force on Risk Management. Managing the Risks from Medical Product Use. Creating a risk management framework. US Department of Health and Human Services, FDA, 1999.
9. Pharmacovigilance Working Party. Notice to Marketing Authorisation Holders: Pharmacovigilance Guidelines. European Agency for the Evaluation of Medicinal Products: London, 1999.
10. Laupacis A, Sackett D, Roberts R. An assessment of clinically useful measures of the consequences of treatment. N Engl J Med 1988; 318: 1728-1733.
11. Cook D, Sackett D. The number needed to treat: a clinically useful measure of treatment effect. BMJ 1995; 310: 452-454.
12. Sackett D, Decks J, Altman D. Down with odd ratios! Evid Based Med 1996; 1: 164-166.
13. Mancini G, Schulzer M. Reporting risks and benefits of therapy by use of the concepts of unqualified success and unmitigated failure: Applications to highly cited trials in cardiovascular medicine. Circulation 1999; 99: 377-383.
14. Guyatt G, Sinclair J, Cook D, Glasziou P. Users' guides to the medical literature XVI. How to use treatment recommendation. JAMA 1999; 281: 1836-1843.
15. Djulbegovic B, Hozo II, Fields K, Sullivan D. High-dose chemotherapy in the adjuvant treatment of breast cancer: Benefit/Risk Analysis. Cancer Control 2000; 5: 394-405.
16. Hutton J. Number needed to treat: properties and problems. J R Statist Soc A 2000; 163: 403-419.
17. Altman D, Andersen P. Calculating the number needed to treat for trials where the outcome is time to an event. Br Med J 1999; 319: 1492-1495.
18. Altman D. Confidence intervals for the number needed to treat. BMJ 1998; 317: 1309-1312.
19. Bender R. Calculating confidence intervals for the number needed to treat. Control Clin Trials 2001; 22: 102-110.
20. Djulbegovic B, Hozo I, Fields K, Sullivan D. High-dose chemotherapy in the adjuvant treatment of breast cancer: benefit/risk analysis. Cancer Control 1998; 5: 394-405.