Evaluating medicines: Let's use all the evidence

Medical Journal of Australia

Volumn 186, Issue 5, 2007, Pages 249-252

  Kelman, Chris W ^a   Pearson, Sallie Anne ^b   Day, Richard O ^b   Holman, C D'Arcy J ^c   Kliewer, Erich V ^d,e   Henry, David A ^f  

^a The Australian National University   (Australia)

^b UNIVERSITY OF NEW SOUTH WALES   (Australia)

^c UNIVERSITY OF WESTERN AUSTRALIA   (Australia)

^d CANCERCARE MANITOBA   (Canada)

^e UNIVERSITY OF MANITOBA   (Canada)

^f UNIVERSITY OF NEWCASTLE   (Australia)

Author keywords

[No Author keywords available]

Indexed keywords

DICLOFENAC; LEFLUNOMIDE; METHOTREXATE; ROFECOXIB; THALIDOMIDE;

AUSTRALIA; BIRTH DEFECT; CLINICAL PRACTICE; CLINICAL RESEARCH; DRUG APPROVAL; DRUG CONTROL; DRUG EFFICACY; DRUG MARKETING; DRUG MONITORING; DRUG SAFETY; DRUG SURVEILLANCE PROGRAM; EVIDENCE BASED MEDICINE; HUMAN; INFORMATION TECHNOLOGY; MEDICAL INFORMATION SYSTEM; PANCYTOPENIA; PHARMACOEPIDEMIOLOGY; POSTMARKETING SURVEILLANCE; REVIEW; RHEUMATOID ARTHRITIS; RISK ASSESSMENT; RISK BENEFIT ANALYSIS;

EID: 33947209116     PISSN: 0025729X     EISSN: None     Source Type: Journal    
DOI: 10.5694/j.1326-5377.2007.tb00883.x     Document Type: Review

References (35)

1. Baciu AS, Stratton K, Burke SP, editors; Committee on the Assessment of the US Drug Safety System. The future of drug safety: promoting and protecting the health of the public. Washington, DC: The National Academies Press, 2006. http://www.nap.edu/catalog/11750.html (accessed Jan 2007).
2. Britton A, McKee M, Black N, et al. Choosing between randomised and non-randomised studies: a systematic review. Health Technol Assess 1998; 2: i-iv and 1-124.
3. Ray WA, Stein CM. Reform of drug regulation - beyond an independent drug-safety board. N Engl J Med 2006; 354: 194-201.
4. Moseley JB, O'Malley K, Petersen NJ, et al. A controlled trial of arthroscopic surgery for osteoarthritis of the knee. N Engl J Med 2002; 347: 81-88.
5. McBride WG. Thalidomide and congenital abnormalities. Lancet 1961; 2: 1358.
6. Australian Government Department of Health and Ageing. Australian adverse drug reactions bulletin 2006. http://www.tga.gov.au/adr/ aadrb.htm (accessed Aug 2006).
7. Hunter D. First, gather the data. N Engl J Med 2006; 354: 329-331.
8. Strom BL. How the US drug safety system should be changed. JAMA 2006; 295: 2072-2075.
9. McLean AJ, Le Couteur DG. Aging biology and geriatric clinical pharmacology. Pharmacol Rev 2004; 56: 163-184.
10. McEwen J, Purcell PM, Hill RL, et al. The incidence of pancytopenia in patients taking leflunomide alone or with methotrexate. Pharmacoepidemiol Drug Saf 2007; 16: 65-73 [published online ahead of print: 24 Apr 2006]. DOI: 10.1002/pds.1236.
11. Australian Government Department of Health and Ageing. Submissions sought on proposed Australia New Zealand Therapeutic Products Authority regulatory scheme. 23 May 2006. http://www.tga.gov.au/tta/consphase1.htm (accessed Sep 2006).
12. Platt R, Ommaya A. A beneficial side effect of the Medicare drug benefit. N Engl J Med 2005; 353: 2742-2743.
13. Nelson MR, Tonkin AM, Cicuttini FM, McNeil JJ. COX-2 inhibitors: exemplars of the drug-safety conundrum [editorial]. Med J Aust 2005; 182: 262-263.
14. Laupacis A, Paterson M, Mamdani M, et al. Gaps in the evaluation and monitoring of new pharmaceuticals: proposal for a different approach. CMAJ 2003; 169: 1167-1170.
15. Jick H, Vasilakis C, Weinrauch LA, et al. A population-based study of appetite-suppressant drugs and the risk of cardiac-valve regurgitation. N Engl J Med 1998; 339: 719-724.
16. Evans JM, MacDonald TM. Record-linkage for pharmacovigilance in Scotland. Brit J Clin Pharmacol 1999; 47: 105-110.
17. Mangano DT, Tudor IC, Dietzel C; Multicenter Study of Perioperative Ischaemia Research Group; Ischaemia Research and Education Foundation. The risk associated with aprotinin in cardiac surgery. N Engl J Med 2006; 354: 353-365.
18. Vlahakes GJ. The value of phase 4 clinical testing. N Engl J Med 2006; 354: 413-415.
19. PHARMO Institute for Drug Outcomes Research. PHARMO report. Innovations in pharmacotherapy. Utrecht: PHARMO Institute, 2000. http:// www.pharmo.net/pdf/reports/Innovations%20in%20Pharmacotherapy.PDF (accessed Dec 2006).
20. Ardoin SP, Sundy JS. Update on nonsteroidal anti-inflammatory drugs. Curr Opin Rheumatol 2006; 18: 221-226.
21. McGettigan P, Henry D. Cardiovascular risk and inhibition of cyclooxygenase: a systematic review of the observational studies of selective and nonselective inhibitors of cyclooxygenase 2. JAMA 2006; 296: 1633-1644.
22. Brameld KJ, Thomas MA, Holman CD, et al. Validation of linked administrative data on end-stage renal failure: application of record linkage to a "clinical base population". Aust N Z J Public Health 1999; 23: 464-467.
23. Holman CD, Bass AJ, Rouse IL, Hobbs MS. Population-based linkage of health records in Western Australia: development of a health services research linked database. Aust N Z J Public Health 1999; 23: 453-459.
24. Stryer D, Tunis S, Hubbard H, Clancy C. The outcomes of outcomes and effectiveness research: impacts and lessons from the first decade. Health Serv Res 2000; 35: 977-993.
25. Chen J, He H, Li J, et al. Representing association classification rules mined from health data. In: Khosla R, Howlett RJ, Jain LC, editors. Knowledge-based intelligent information and engineering. Lecture Notes in Computer Science. Vol. 3683. Berlin: Springer, 2005: 1225-1231.
26. Li J, Fu AW, He H, et al. Mining risk patterns in medical data. In: Grossman RL, Bayardo R, Bennett K, Vaidya J, editors. Proceedings of the 11th ACM SIGKDD International Conference on Knowledge Discovery and Data Mining; 2005 Aug 21-24; Chicago, III. New York: ACM Press, 2005: 770-775.
27. The Sax Institute. Centre for Health Record Linkage. http:// www.saxinstitute.org.au/researchassetsprograms/ BetterHealthServicesThrough-Research/ CentreforHealthRecordLinkage.cfm?objid=647 (accessed Jan 2007).
28. Kelman CW, Bass AJ, Holman CD. Research use of linked health data - a best practice protocol. Aust N Z J Public Health 2002; 26: 251-255.
29. Evans JM, MacDonald TM. Misclassification and selection bias in case-control studies using an automated database. Pharmacoepidemiol Drug Saf 1997; 6: 313-318.
30. Pukkala E, Tulenheimo-Silfvast A, Leminen A. Incidence of cancer among women using long versus monthly cycle hormonal replacement therapy, Finland 1994-1997. Cancer Causes Control 2001; 12: 111-115.
31. Sorensen HT, Mellemkjaer L, Olsen JH. Risk of suicide in users of beta-adrenoceptor blockers, calcium channel blockers and angiotensin converting enzyme inhibitors. Br J Clin Pharmacol 2001; 52: 313-318.
32. Australian Government Department of Health and Ageing. National medicines policy 2000. http://www.health.gov.au/internet/wcms/ publishing.nsf/Content/nmp-objectives-policy.htm/$FILE/nmp2000.pdf (accessed Aug 2006).
33. Best Practice Advocacy Centre. Responsible use of pharmaceuticals. Best practice guidelines. 2006. http://www.bpac.org.nz/ (accessed Aug 2006).
34. Australian Government Department of Education, Science and Training. National Collaborative Research Infrastructure Strategy (NCRIS). 2005. http://www.dest.gov.au/sectors/research_sector /policies_issues_reviews/key_issues/ncris/default.htm (accessed Aug 2006).
35. Prime Minister's Science, Engineering and Innovation Council (PMSEIC) Working Group. From data to wisdom: pathways to successful data management for Australian science. Working group on data for science report to PMSEIC. Canberra: PMSEIC, Dec 2006. http://www.dest.gov.au/ sectors/science_innovation/publications_resources/profiles/ Presentation_Data_for_Science.htm (accessed Jan 2007).