Comparator bias: Why comparisons must address genuine uncertainties

Journal of the Royal Society of Medicine, Supplement

Volumn 106, Issue 1, 2013, Pages 30-33

  Mann, Howard ^a   Djulbegovic, Benjamin ^b  

^a UNIVERSITY OF UTAH SCHOOL OF MEDICINE   (United States)

^b UNIVERSITY OF SOUTH FLORIDA   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

ATENOLOL; CELECOXIB; DICLOFENAC; DISEASE MODIFYING ANTIRHEUMATIC DRUG; ERYTHROPOIETIN; ETORICOXIB; HALOPERIDOL; NAPROXEN; NONSTEROID ANTIINFLAMMATORY AGENT; PLACEBO; STREPTOMYCIN; THIAZIDE DIURETIC AGENT; DRUG;

ANEMIA; ARTHRITIS; ARTICLE; BLEEDING; CARDIOVASCULAR DISEASE; DRUG MEGADOSE; HUMAN; LOW DRUG DOSE; LUNG TUBERCULOSIS; MEDICATION ERROR; META ANALYSIS (TOPIC); OSTEOARTHRITIS; RANDOMIZED CONTROLLED TRIAL (TOPIC); RHEUMATOID ARTHRITIS; SCHIZOPHRENIA; SYSTEMATIC REVIEW (TOPIC); COMPARATIVE STUDY; CONTROLLED CLINICAL TRIAL (TOPIC); EXTRAPYRAMIDAL SYMPTOM; FOOD AND DRUG ADMINISTRATION; EPIDEMIOLOGY; STANDARD; TREATMENT OUTCOME; UNCERTAINTY;

BIAS (EPIDEMIOLOGY); CONTROLLED CLINICAL TRIALS AS TOPIC; HUMANS; PHARMACEUTICAL PREPARATIONS; TREATMENT OUTCOME; UNCERTAINTY;

MLCS; MLOWN;

EID: 84873813037     PISSN: 02675331     EISSN: None     Source Type: Journal    
DOI: 10.1177/0141076812474779     Document Type: Article

References (35)

1. Silverman WA. Personal reflections on lessons learned from randomized trials involving newborn infants, 1951 to 1967. JLL Bulletin: Commentaries on the history of treatment evaluation. 2003. (www.jameslindlibrary.org)
2. Djulbegovic B, Kumar A, Glasziou PP, Perera R, Reljic T, Dent L, Raftery J, Johansen M, Di Tanna GL, Miladinovic M, Soares HP, Vist GE, Chalmers I. New treatments compared to established treatments in randomized trials. Cochrane Database of Systematic Reviews 2012, Issue 10. Art. No.: MR000024. DOI:10.1002/14651858.MR000024.pub3.
3. Medical Research Council. Streptomycin treatment of pulmonary tuberculosis: a Medical Research Council investigation. BMJ 1948b;2:769-782
4. Amberson JB, McMahon BT, Pinner M. A clinical trial of sanocrysin in pulmonary tuberculosis. American Review of Tuberculosis 1931;24:401-435
5. Hill AB. Medical ethics and controlled trials. BMJ 1963;1:1043-1049
6. Djulbegovic B, Lacevic M, Cantor A, Fields KK, Bennett CL, Adams JR, Kuderer NM, Lyman GH. The uncertainty principle and industry-sponsored research. Lancet 2000;356:635-638
7. Djulbegovic B. Acknowledgment about uncertainty: a fundamental means to ensure scientific and ethical validity in research. Current Oncology Reports 2001;3:389-395
8. Djulbegovic B, Hozo I, Greenland S. Uncertainty in clinical Medicine. In: Gifford F, ed. Philosophy of Medicine (Handbook of the Philosophy of Science). London: Elsevier, 2011
9. Peto R, Baigent C. Trials: the next 50 years. BMJ 1998;317:1170-1171
10. Freedman B. Equipoise and the ethics of clinical research. N Engl J Med 1987;317:141-5
11. Edwards SJL, Lilford RJ, Braunholtz DA, Jackson JC, Hewison J, Thornton J. Ethical issues in the design and conduct of randomized controlled trials. Health Technol Assessment 1998;2:1-130
12. Sackett DL, Oxman AD. HARLOT plc: an amalgamation of the world's two oldest professions. BMJ 2003;327:1442-1445
13. Montori VM, Jaeschke R, Schunemann HJ, Bhandari M, Brozek JL, Devereaux PJ, Guyatt GH. Users' guide to detecting misleading claims in clinical research reports. BMJ 2004;329:1093-6
14. Garattini S, Chalmers I. Patients and the public deserve big changes in evaluation of drugs. BMJ 2009;338:804-806
15. Sox HC. Defining comparative effectiveness research: the importance of getting it right. Med Care 2010;48(6 Suppl): S7-8
16. Goldberg NH, Schneeweiss S, Kowal MK, Gagne JJ. Availability of comparative efficacy data at the time of drug approval in the United States. JAMA 2011;305:1786-9
17. Estellat C, Ravaud P. Lack of head-to-head trials and fair control arms: randomized controlled trials of biologic treatment for rheumatoid arthritis. Arch Intern Med 2012;172:237-44
18. Clark O, Adams JR, Bennett CL, Djulbegovic B. Erythropoietin, uncertainty principle and cancer related anaemia. BMC Cancer 2002;2(2):23
19. Psaty BM, Weiss NS, Furberg CD. Recent trials in hypertension: compelling science or commercial speech? JAMA 2006;295:1704-6
20. Rochon PA, Gurwitz JH, Simms RW, et al. A study of manufacturer-supported trials of nonsteroidal anti-inflammatory drugs in the treatment of arthritis. Arch Intern Med 1994;154:157-63
21. Johansen HK, Gotzsche PC. Problems in the design and reporting of trials of antifungal agents encountered during meta-analysis. JAMA 1999;282:1752-9
22. Hunter R, Kennedy E, Song F, Gadon L, Irving CB. Risperidone versus typical antipsychotic medication for schizophrenia. Cochrane Database of Systematic Reviews 2003, Issue 2. Art. No.: CD000440. DOI: 10.1002/14651858. CD000440
23. Safer DJ. Design and reporting modifications in industry-sponsored comparative psychopharmacology trials. J Nerv Ment Dis 2002;190(9):583-92
24. Cannon CP, Curtis SP, FitzGerald GA, Krum H, Kaur A, Bolognese JA, Reicin AS, Bombardier C, Weinblatt ME, van der Heijde D, Erdmann E, Laine L. Cardiovascular outcomes with etoricoxib and diclofenac in patients with osteoarthritis and rheumatoid arthritis in the Multinational Etoricoxib and Diclofenac Arthritis Long-term (MEDAL) programme: a randomised comparison. Lancet 2006;368:1771-81
25. Psaty BM, Weiss NS. NSAID. Trials and the choice of comparators - questions of public health importance. N Engl J Med 2007;356:328-30
26. Kearney PM, Baigent C, Godwin J, Halls H, Emberson JR, Patrono C. Do selective cyclo-oxygenase-2 inhibitors and traditional non-steroidal anti-inflammatory drugs increase the risk of atherothrombosis? Meta-analysis of randomised trials. BMJ 2006;332:1302-8
27. Djulbegovic B. Articulating and responding to uncertainties in clinical research. J Med Philosophy 2007;32:79-98
28. Cooper N, Jones D, Sutton A. The use of systematic reviews when designing studies. Clinical Trials 2005; 2:260-264
29. Robinson KA, Goodman SN. A systematic examination of the citation of prior research in reports of randomized, controlled trials. Ann Int Med 2011;154:50-55
30. Mann H, Djulbegovic B. Choosing a control intervention for a randomised clinical trial. BMC Med Res Methodol 2003;3:7
31. Rothman KJ, Michels KB, Baum M. Declaration of Helsinki should be strengthened. For and against. BMJ 2000;321:442-5
32. FDA. Guidance for Industry. E 10 Choice of Control Group and Related Issues in Clinical Trials. ICH. 2001 (available at http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM073139.pdf) (accessed July 12, 2012)
33. Pearson SD. Placebo-controlled trials, ethics, and the goals of comparative effectiveness research: comment on "lack of head-to-head trials and fair control arms". Arch Intern Med 2012;172:244-5
34. Van Luin JCF, van Loenen AC, Gribnau FWJ, Leufkens HGM. Choice of comparator in active control of new drugs. Annals of Pharmacology 2008;42:1605-1612
35. Evans I, Thornton H, Chlamers I, Glasziou P. Testing treatments. London: Pinter and Martin, 2011; www.testingtreatments.org