Zasady wyboru komparatora w badaniach klinicznych Artykuł przeglądowy
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Opublikowane:
cze 30, 2022
Słowa kluczowe:
badania kliniczne, wybór komparatora, stronniczość w doborze
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Abstrakt
Przy wyborze aktywnej grupy kontrolnej w randomizowanym badaniu klinicznym ważne jest utrzymanie standardowego leczenia we wskazaniu terapeutycznym, w którym badany jest nowy lek. Wybór ten ma znaczenie nie tylko dla wykazania skuteczności i bezpieczeństwa nowego leku, ale także dla oceny jego miejsca w terapii w porównaniu z aktualnie stosowanymi lekami. Informacje wynikające z porównania leków są ważne przy podejmowaniu decyzji dotyczących ich stosowania i refundacji. Wybór najodpowiedniejszego komparatora jest jednym z najważniejszych elementów planowania badania.
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Artykuły
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Bibliografia
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12. Lathyris DN, Patsopoulos NA, Salanti G et al. Industry sponsorship and selection of comparators in randomized clinical trials. Eur J Clin Invest. 2010; 40(2): 172-82.
13. Dawson L, Zarin DA, Emanuel EJ et al. Considering usual medical care in clinical trial design. PLoS Med. 2009; 6: e1000111.
14. Van Luijn JCF, Van Loenen AC, Gribnau FWJ et al. Choice of comparator in active control trials of new drugs. Ann Pharmacother. 2008; 42: 1605-12
15. Johansen HK, Gøtzsche PC. Problems in the design and reporting of trials of antifungal agents encountered during meta-analysis. JAMA. 1999; 282: 1752-9.
16. Freedland KE, King AC, Ambrosius WT et al.; National Institutes of Health Office of Behavioral and Social Sciences Research Expert Panel on Comparator Selection in Behavioral and Social Science Clinical Trials. The selection of comparators for randomized controlled trials of health-related behavioral interventions: recommendations of an NIH expert panel. J Clin Epidemiol. 2019; 110: 74-81.
17. van Luijn JC, van Loenen AC, Gribnau FW et al. Choice of comparator in active control trials of new drugs. Ann Pharmacother. 2008; 42(11): 1605-12.
18. Agencja Oceny Technologii Medycznych i Taryfikacji. Wytyczne oceny technologii medycznych, Warszawa 2016 (access: 23.09.2022).
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20. European Medicines Agency. Procedural advice for users of the centralized procedure for similar biological medicinal products applications. London: EMA, 2009.
21. Piaggio G, Elbourne DR, Pocock SJ et al. Reporting of noninferiority and quivalence randomised trials: extension of the CONSORT 2010 statement. JAMA. 2012; 308: 2594-604.
2. Gokhale M, Buse JB, Gray CL et al. Dipeptidyl-peptidase-4 inhibitors and pancreatic cancer: a cohort study. Diabetes Obes Metab. 2014; 16(12): 1247-56.
3. Graham DJ, Ouellet-Hellstrom R, MaCurdy TE et al. Risk of acute myocardial infarction, stroke, heart failure, and death in elderly Medicare patients treated with rosiglitazone or pioglitazone. JAMA. 2010; 304(4): 411-8.
4. Millum J, Grady C. The ethics of placebo-controlled trials: methodological justifications. Contemp Clin Trials. 2013; 36(2): 510-4.
5. Peyrin-Biroulet L, Lopez A, Sandborn W. Head-to-head Comparative Studies: Challenges and Opportunities? J Crohns Colitis. 2017; 11(suppl_2): S567-S575.
6. Lewis JA. Study designs, duration, and choice of comparators including the use of placebo. Dialogues Clin Neurosci. 2002; 4(4): 463-9.
7. Walker J. Non-inferiority statistics and equivalence studies. BJA Educ. 2019; 19(8): 267-71.
8. Carpenter WT Jr, Schooler NR, Kane JM. The rationale and ethics of medication-free research in schizophrenia. Arch Gen Psychiatry. 1997; 54(5): 401-7.
9. Baldwin D, Broich K, Fritze J et al. Placebo-controlled studies in depression: necessary, ethical and feasible. Eur Arch Psychiatry Clin Neurosci. 2003; 253(1): 22-8.
10. Fritze J, Möller HJ. Design of clinical trials of antidepressants: should a placebo control arm be included? CNS Drugs. 2001; 15(10): 755-64.
11. Laporte JR, Figueras A. Placebo effects in psychiatry. Lancet. 1994; 344(8931): 1206-9.
12. Lathyris DN, Patsopoulos NA, Salanti G et al. Industry sponsorship and selection of comparators in randomized clinical trials. Eur J Clin Invest. 2010; 40(2): 172-82.
13. Dawson L, Zarin DA, Emanuel EJ et al. Considering usual medical care in clinical trial design. PLoS Med. 2009; 6: e1000111.
14. Van Luijn JCF, Van Loenen AC, Gribnau FWJ et al. Choice of comparator in active control trials of new drugs. Ann Pharmacother. 2008; 42: 1605-12
15. Johansen HK, Gøtzsche PC. Problems in the design and reporting of trials of antifungal agents encountered during meta-analysis. JAMA. 1999; 282: 1752-9.
16. Freedland KE, King AC, Ambrosius WT et al.; National Institutes of Health Office of Behavioral and Social Sciences Research Expert Panel on Comparator Selection in Behavioral and Social Science Clinical Trials. The selection of comparators for randomized controlled trials of health-related behavioral interventions: recommendations of an NIH expert panel. J Clin Epidemiol. 2019; 110: 74-81.
17. van Luijn JC, van Loenen AC, Gribnau FW et al. Choice of comparator in active control trials of new drugs. Ann Pharmacother. 2008; 42(11): 1605-12.
18. Agencja Oceny Technologii Medycznych i Taryfikacji. Wytyczne oceny technologii medycznych, Warszawa 2016 (access: 23.09.2022).
19. Provisional List of Comparator Products for in vivo and/or in vitro Equivalence Studies (access: 23.09.2022).
20. European Medicines Agency. Procedural advice for users of the centralized procedure for similar biological medicinal products applications. London: EMA, 2009.
21. Piaggio G, Elbourne DR, Pocock SJ et al. Reporting of noninferiority and quivalence randomised trials: extension of the CONSORT 2010 statement. JAMA. 2012; 308: 2594-604.