Negative results in cancer clinical trials - Equivalence or poor accrual?

Controlled Clinical Trials

Volumn 25, Issue 5, 2004, Pages 525-533

  Costa, Luciano J M ^a   Xavier, Ana Carolina G ^b   Del Giglio, Auro ^c  

^a UNIVERSITY OF COLORADO   (United States)

^b UNIVERSITY OF SÃO PAULO   (Brazil)

^c FACULDADE DE MEDICINA DO ABC   (Brazil)

Author keywords

Clinical trials; Neoplasms; Statistical studies; Therapeutic equivalency

Indexed keywords

ANTINEOPLASTIC AGENT; NEW DRUG;

ANTINEOPLASTIC ACTIVITY; ARTICLE; CALCULATION; CANCER PATIENT; CANCER RADIOTHERAPY; CANCER SURGERY; CANCER SURVIVAL; CHI SQUARE TEST; CLINICAL TRIAL; COMPARATIVE STUDY; CONFIDENCE INTERVAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DATA ANALYSIS; EVALUATION; HUMAN; INFORMATION PROCESSING; MALIGNANT NEOPLASTIC DISEASE; NEOPLASM; OUTCOMES RESEARCH; RANDOMIZATION; SAMPLE; TOXICITY; VALIDATION PROCESS;

EID: 4644254894     PISSN: 01972456     EISSN: None     Source Type: Journal    
DOI: 10.1016/j.cct.2004.08.001     Document Type: Note

References (12)

1. B. Jones, P. Jarvis, J.A. Lewis, and A.F. Ebbutt Trials to assess equivalence: the importance of rigorous methods BMJ 313 1996 36 39
2. D.G. Altman, and J.M. Bland Absence of evidence is not evidence of absence BMJ 311 1995 485
3. J.A. Freiman, T.C. Chalmers, H. Smith Jr., and R.R. Kuebler The importance of beta, the type II error and sample size in the design and interpretation of the randomized control trial. Survey of 71 "negative" trials N. Engl. J. Med. 299 1978 690 694
4. J.B. Dimick, M. Diener-West, and P.A. Lipsett Negative results of randomized clinical trials published in the surgical literature: equivalency or error? Arch. Surg. 136 2001 796 800
5. W.L. Greene, J. Concato, and A.R. Feinstein Claims of equivalence in medical research: are they supported by the evidence? Ann. Intern. Med. 132 2000 715 722
6. C.W. Dunnett, and M. Gent Significance testing to establish equivalence between treatments, with special reference to data in the form of 2 x 2 tables Biometrics 33 1977 593 602
7. D.J. Krysan, and A.R. Kemper Claims of equivalence in randomized controlled trials of the treatment of bacterial meningitis in children Pediatr. Infect Dis. J. 21 2002 753 758
8. J.C. Gunsolley, R.K. Elswick, and J.M. Davenport Equivalence and superiority testing in regeneration clinical trials J. Periodontol. 69 1998 521 527
9. A.R. Feinstein Clinical biostatistics: XXXIV. The other side of 'statistical significance': alpha, beta, delta, and the calculation of sample size Clin. Pharmacol. Ther. 18 1975 491 505
10. W.W. Hauck, and S. Anderson A proposal for interpreting and reporting negative studies Stat. Med. 5 1986 203 209
11. T.R. Fleming Design and interpretation of equivalence trials Am. Heart J. 139 2000 S171 S176
12. A. Di Leo, H. Bleiberg, and M. Buyse Overall survival is not a realistic end point for clinical trials of new drugs in advanced solid tumors: a critical assessment based on recently reported phase III trials in colorectal and breast cancer J. Clin. Oncol. 21 2003 2045 2047