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Statistical controversies in clinical research

 

‘Statistical controversies in clinical research’:
a series of articles published in The Annals of Oncology

 

Editorial: ‘The new series ‘Statistical Controversies in Clinical Research’ is aimed at facilitating the involvement of oncologists in the debate. The series will include papers that outline novel methodology not yet in wide use; propose nonstandard or controversial trial designs, end points, or methods of analysis; discuss hard-to-interpret findings in actual clinical trials and other types of studies; and present controversies surrounding the design or analysis of specific clinical trials and other types of studies. The papers will be written with the readership of Annals of Oncology in mind; they will emphasize statistical aspects but will not be cluttered by technical details; they will include real-life examples and case studies; they will raise controversial issues but will not depart from sound methodology assessed by peer reviewers’.

Access the full-text of this editorial at: Soria JC, Buyse M. ‘Statistical controversies in clinical research’: a new series in Annals of Oncology. Ann Oncol. 2015;26(8):1532. PMID: 25904726

 

2017

Rockhold FW. Statistical controversies in clinical research: data access and sharing-can we be more transparent about clinical research? Let’s do what’s right for patients. Ann Oncol. 2017;28(8):1734-1737. PMID: 28383637

Bell ML, Fiero MH, Dhillon HM, Bray VJ, Vardy JL. Statistical controversies in cancer research: using standardized effect size graphs to enhance interpretability of cancer-related clinical trials with patient-reported outcomes. Ann Oncol. 2017;28(8):1730-1733. PMID: 28327975

Boonstra PS, Braun TM, Taylor JMG, Kidwell KM, Bellile EL, Daignault S, Zhao L, Griffith KA, Lawrence TS, Kalemkerian GP, Schipper MJ. Statistical controversies in clinical research: building the bridge to phase II-efficacy estimation in dose-expansion cohorts. Ann Oncol. 2017;28(7):1427-1435. PMID: 28200082

Lesaffre E, Edelman MJ, Hanna NH, Park K, Thatcher N, Willemsen S, Gaschler-Markefski B, Kaiser R, Manegold C. Statistical controversies in clinical research: Futility analyses in oncology – lessons on potential pitfalls from a randomised controlled trial. Ann Oncol. 2017;28(7):1419-1426. PMID: 28184431

Le-Rademacher J, Hillman SL, Meyers J, Loprinzi CL, Limburg PJ, Mandrekar SJ. Statistical controversies in clinical research Value of adverse events relatedness to study treatment: Analyses of data from randomized double-blind placebo-controlled clinical trials. Ann Oncol. 2017;28(6):1183-1190. PMID: 28184420

Park JH, Eisenhut M, Vliet HJ, Shin JI. Statistical controversies in clinical research: overlap and errors in the meta-analyses of microRNA genetic association studies in cancers. Ann Oncol. 2017;28(6):1169-1182. PMID: 28327894

Herrmann D, Sinnett P, Holmes J, Khan S, Koller C, Vassar M. Statistical controversies in clinical research: Publication bias evaluations are not routinely conducted in clinical oncology systematic reviews. Ann Oncol. 2017;28(5):931-937. PMID: 28039176

Perlmutter AS, Tran VT, Dechartres A, Ravaud P. Statistical controversies in clinical research: comparison of primary outcomes in protocols, public clinical-trial registries and publications: the example of oncology trials. Ann Oncol. 2017;28(4):688-695. PMID: 28011448

Wages NA, Slingluff CL, Jr., Petroni GR. Statistical controversies in clinical research: early-phase adaptive design for combination immunotherapies. Ann Oncol. 2017;28(4):696-701. PMID: 28011450

Renfro LA, Sargent DJ. Statistical controversies in clinical research: basket trials, umbrella trials, and other master protocols: a review and examples. Ann Oncol. 2017;28(1):34-43. PMID: 28177494


2016

Michiels S, Ternes N, Rotolo F. Statistical controversies in clinical research: prognostic gene signatures are not (yet) useful in clinical practice. Ann Oncol. 2016;27(12):2160-2167. PMID: 27634691

Filleron T, Kouokam W, Gilhodes J, Duhamel A, Penel N, Joly F, Tresch-Bruneel E, Kramar A, Houede N. Statistical controversies in clinical research: should schedules of tumor size assessments be changed? Ann Oncol. 2016;27(11):1981-1987. PMID: 27502711

Gleiss A, Zeillinger R, Braicu EI, Trillsch F, Vergote I, Schemper M. Statistical controversies in clinical research: the importance of importance. Ann Oncol. 2016;27(7):1185-1189. PMID: 27052655

Buyse M, Hurvitz SA, Andre F, Jiang Z, Burris HA, Toi M, Eiermann W, Lindsay MA, Slamon D. Statistical controversies in clinical research: statistical significance-too much of a good thing. Ann Oncol. 2016;27(5):760-762. PMID: 26861602

Saad ED, Buyse M. Statistical controversies in clinical research: end points other than overall survival are vital for regulatory approval of anticancer agents. Ann Oncol. 2016;27(3):373-378. PMID: 26578738
van Halteren HK. Reply to ‘Statistical controversies in clinical research: end points other than survival are vital for regulatory approval of anticancer agents’ by Saad and Buyse. Ann Oncol. 2016;27(8):1652-1653. PMID: 27241134
Saad ED, Buyse M. Response to the letter to the editor ‘Reply to “Statistical controversies in clinical research: end points other than survival are vital for regulatory approval of anticancer agents” by H. K. van Halteren’. Ann Oncol. 2016;27(8):1653. PMID: 27154422

Korn EL, Sachs MC, McShane LM. Statistical controversies in clinical research: assessing pathologic complete response as a trial-level surrogate end point for early-stage breast cancer. Ann Oncol. 2016;27(1):10-15. PMID: 26489443


2015

Cuzick J. Statistical controversies in clinical research: long-term follow-up of clinical trials in cancer. Ann Oncol. 2015;26(12):2363-2366. PMID: 26433395

Heller G. Statistical controversies in clinical research: an initial evaluation of a surrogate end point using a single randomized clinical trial and the Prentice criteria. Ann Oncol. 2015;26(10):2012-2016. PMID: 26254442

Paoletti X, Ezzalfani M, Le Tourneau C. Statistical controversies in clinical research: requiem for the 3 + 3 design for phase I trials. Ann Oncol. 2015;26(9):1808-1812. PMID: 26088197

Thall P, Fox P, Wathen J. Statistical controversies in clinical research: scientific and ethical problems with adaptive randomization in comparative clinical trials. Ann Oncol. 2015;26(8):1621-1628. PMID: 25979922