Methodological quality and reporting of ethical requirements in phase III cancer trials

Journal of Medical Ethics

Volumn 31, Issue 5, 2005, Pages 251-255

  Tuech, J J ^a,b,e   Pessaux, P ^c   Moutel, G ^a   Thoma, V ^d   Shraub, S ^d   Herve, C ^a  

^a UNIVERSITÉ PARIS DESCARTES   (France)

^b University Hospital   (France)

^c ANGERS UNIVERSITY HOSPITAL   (France)

^d Paul Strauss Centre   (France)

^e CENTRE HOSPITALIER DE MULHOUSE   (France)

Author keywords

[No Author keywords available]

Indexed keywords

ANTINEOPLASTIC AGENT;

ARTICLE; CANCER; CANCER RESEARCH; CLINICAL STUDY; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; CORRELATION ANALYSIS; HUMAN; INFORMED CONSENT; MANDATORY REPORTING; MEDICAL ETHICS; METHODOLOGY; PROFESSIONAL STANDARD; PUBLISHING; QUALITY CONTROL; RANDOMIZED CONTROLLED TRIAL; REFUSAL TO PARTICIPATE; RISK BENEFIT ANALYSIS; SAMPLE SIZE; SCORING SYSTEM;

BIOMEDICAL AND BEHAVIORAL RESEARCH; EMPIRICAL APPROACH;

CLINICAL TRIALS, PHASE III; ETHICS COMMITTEES, RESEARCH; HUMANS; INFORMED CONSENT; NEOPLASMS; PERIODICALS; RANDOMIZED CONTROLLED TRIALS; RESEARCH DESIGN;

EID: 18844383680     PISSN: 03066800     EISSN: None     Source Type: Journal    
DOI: 10.1136/jme.2003.007435     Document Type: Article

References (32)

1. Ko CY, Sack J, Chang JT, et al. Reporting randomized, controlled trials: where quality of reporting may be improved. Dis Colon Rectum 2002;45:443-7.
2. Jadad AR, Rennie D. The randomized controlled trial gets a middle aged checkup. JAMA 1998;279:319-20.
3. Schulz KF, Chalmers I, Hayes RJ, et al. Empirical evidence of bias. JAMA 1995;274:1456-8.
4. Moher D, Dulberg CS, Wells GA. Statistical power, sample size, and their reporting in randomized controlled trials. JAMA 1994;272:122-4.
5. Ruiz-Canela M, Martinez-Gonzalez MA, Gomez-Gracia E, et al. Informed consent and approval by institutional review boards in published reports on clinical trials [published erratum appears in N Engl J Med 1999;341:460]. N Engl J Med 1999;340:1114-5.
6. Matot I, Pizov R, Sprung CL. Evaluation of institutional review board review and informed consent in publications of human research in critical care medicine. Crit Care Med 1998; 26:1596-602.
7. Merz JF, Leonard DG, Miller ER. IRB review and consent in human tissue research. Science 1999;283:1647-8.
8. Karlawish JH, Hougham GW, Stocking CB, et al. What is the quality of the reporting of research ethics in publications of nursing home research? J Am Geriatr Soc 1999;47:76-81.
9. Jadad AR, Moore RA, Carroll D, et al. Assessing the quality of reports of randomized clinical trials: is blinding necessary? Control Clin Trials 1996;17:1-12.
10. Berdeu D, Alric R, Fourcade J, et al. Qualité éthigue et qualité méthodologique des essais contrôlés randomisés, à partir des études publiées de 1989 à 1992, dans quatre revues internationales. (Methodological Quality and reporting of ethical requirements in randomized trials published between 1989 and 1992 in four international medical journals.) In: Herve C, ed. Les cahiers d'ethique médicale, collection l'ethique en mouvement. Paris, Editions l'Harmattan, 1998:117-37 (French).
11. Meningaud JP, Berdeu D, Moutel G, et al. Ethical assessment of clinical research publications. Med Law 2001; 20:595-603.
12. Felson DT. Bias in meta-analytic research. J Clin Epidemiol 1992;45:885-92.
13. Moher D, Olkin I. Meta-analysis of randomized controlled trials. A concern for standards. JAMA 1995; 274:1962-4.
14. Moher D, Jadad AR, Nichol G, et al. Assessing the quality of randomized controlled trials: an annotated bibliography of scales and checklists. Control Clin Trials 1995;16:62-73.
15. Detsky AS, Naylor CD, O'Rourke K, et al. Incorporating variations in the quality of individual randomized trials in meta-analysis. J Clin Epidemiol 1992;45:255-65.
16. Khan KS, Daya S, Jadad A. The importance of quality of primary studies in producing unbiased systematic reviews. Arch Intern Med 1996;15:661-6.
17. Moher D, Jadad AR, Nichol G, et al. Assessing the quality of randomized controlled trials: current issues and future directions. Int J Technol Assess Health Care 1996; 12:195-208.
18. Chalmers TC, Smith H, Blackburn B, et al. A method for assessing the quality of a randomized controlled trial. Control Clin Trials 1981;2:31-49.
19. Pocock SJ, Hughes MD, Lee RJ. Statistical problems in the reporting of clinical trials. A survey of three medical journals. N Engl J Med 1987;317:426-32.
20. Hollis S, Campbell F. What is meant by intention to treat analysis? Survey of published randomised controlled trials. BMJ 1999;319:670-4.
21. Schulz KF, Chalmers I, Grimes DA, et al. Assessing the quality of randomization from reports of controlled trials published in obstetrics and gynecology journals. JAMA 1994; 272:125-8.
22. Altman DG. Better reporting of randomised controlled trials: the CONSORT statement. BMJ 1996;313:570-1.
23. Moher D, Schulz KF, Altman DG, for the CONSORT Group. The CONSORT statement: revised recommendations for improving the quality of reports of parallel group randomized trials. Lancet 2001; 357:1191-4.
24. Anonymous. Verslaglegging van gerandomiseerd medisch-wetenschappelijk onderzoek volgens een standaardmethode; de 'Consolidation of the standards of reporting trials' (CONSORT). [A standard method for reporting randomized medical scientific research; the 'Consolidation of the standards of reporting trials' (CONSORT).] Ned Tijdschr Geneeskd 1998;142:1089-91 (Dutch).
25. Huston P, Hoey J. CMAJ endorses the CONSORT statement. CONsolidation of Standards for Reporting Trials. CMAJ 1996; 155:1277-82.
26. Davidoff F. News from the International Committee of Medical Journal Editors. Ann Intern Med 2000;133:229-31.
27. Moher D, Jones A, Lepage L, CONSORT Group. Use of the CONSORT statement and quality of reports of randomized trials: a comparative before-and-after evaluation. JAMA 2001; 285:1992-5.
28. Berdeu D, Herve C, Fourcade J. Clinical trials in the elderly: ethical and methodologic considerations. Rev Med Interne 2000;21:614-22.
29. Rennie D, Yank V. Disclosure to the reader of institutional review board approval and informed consent. JAMA 1997;277:922-3.
30. Sutherland HJ, Meslin EM, Till JE. What's missing from current trial guidelines? A framework for integrating science, ethics, and the community contest. J Clin Ethics 1994;5:297-303.
31. Pearn J. Publication: an ethical imperative. BMJ 1995;310:1313-5.
32. Weijer C, Shapiro S, Fiks A, et al. Monitoring clinical research: an obligation unfulfilled. CMAJ 1995; 152:1973-80.