Overestimation of the effect size in group sequential trials

Clinical Cancer Research

Volumn 18, Issue 18, 2012, Pages 4872-4876

  Zhang, Jenny J ^a   Blumenthal, Gideon M ^a   He, Kun ^a   Tang, Shenghui ^a   Cortazar, Patricia ^a   Sridhara, Rajeshwari ^a  

^a CENTER FOR DRUG EVALUATION AND RESEARCH   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

ANALYTICAL ERROR; ARTICLE; CANCER RESEARCH; CLINICAL PRACTICE; DRUG EFFECT; DRUG EFFICACY; DRUG INFORMATION; DRUG WITHDRAWAL; EFFECT SIZE; GROUP SEQUENTIAL DESIGN; METHODOLOGY; OUTCOME ASSESSMENT; PHASE 3 CLINICAL TRIAL (TOPIC); PRIORITY JOURNAL; PROGRESSION FREE SURVIVAL; RANDOMIZED CONTROLLED TRIAL (TOPIC); STUDY DESIGN; TREATMENT OUTCOME;

CLINICAL TRIALS, PHASE III AS TOPIC; HUMANS; NEOPLASMS; RESEARCH DESIGN; TREATMENT OUTCOME;

EID: 84866389504     PISSN: 10780432     EISSN: 15573265     Source Type: Journal    
DOI: 10.1158/1078-0432.CCR-11-3118     Document Type: Article

References (16)

1. Pocock SJ. Group sequential methods in the design and analysis of clinical trials. Biometrika 1977;64:191-9.
2. O'Brien PC, Fleming TR. A multiple testing procedure for clinical trials. Biometrics 1979;35:549-56.
3. DeMets DL, Lan KK. Interim analysis: the alpha spending function approach. Stat Med 1994;13:1341-52.
4. Hughes MD, Pocock SJ. Stopping rules and estimation problems in clinical trials. Stat Med 1988;7:1231-42.
5. Fleming TR. Standard versus adaptive monitoring procedures: a commentary. Stat Med 2006;25:3305-12.
6. Letters to the Editor regarding Bassler et al. Bias and trials stopped early for benefit. JAMA 2010;304:156-9.
7. Bassler D, Briel M, Montori VM, Lane M, Glasziou P, Zhou Q, et al. Stopping randomized trials early for benefit and estimation of treatment effects: systematic review and meta-regression analysis. JAMA 2010;303:1180-7.
8. Geyer CE, Forster J, Lindquist D, Chan S, Romieu G, Pienkowski T, et al. Lapatinib plus capecitabine for HER2-positive advanced breast cancer. N Engl J Med 2006;355:2733-43.
9. Cameron D, Casey M, Press M, Lindquist D, Pienkowski T, Romieu G, et al. A phase III randomized comparison of lapatinib plus capecitabine versus capecitabine alone in women with advanced breast cancer that has progressed on trastuzumab: updated efficacy and biomarker analyses. Breast Cancer Res Treat 2008;112:533-43.
10. Motzer RJ, Hutson TE, Tomczak P, Michaelson MD, Bukowski RM, Rixe O, et al. Sunitinib versus interferon alfa in metastatic renal-cell carcinoma. N Engl J Med 2007;256:115-24.
11. Motzer RJ, Hutson TE, Tomczak P, Michaelson MD, Bukowski RM, Oudard S, et al. Overall survival and updated results for sunitinib compared with interferon alfa in patients with metastatic renal cell carcinoma. J Clin Oncol 2009;27:3584-90.
12. Emerson SS, Fleming TR. Parameter estimation following sequential hypothesis testing. Biometrika 1990;77:875-92.
13. Pinheiro JC, DeMets DL. Estimating and reducing bias in group sequential designs with Gaussian independent structure. Biometrika 1997;84:831-43.
14. Goodman SN. Stopping at nothing? some dilemmas of data monitoring in clinical trials. Ann Intern Med 2007;146:882-7.
15. Whitehead J. On the bias of maximum likelihood estimation following a sequential test. Biometrika 1896;73:573- 81.
16. Fan XF, DeMets DL, Lan KK. Conditional bias of point estimates following a group sequential test. J Biopharm Stat 2004;14:505-30.