Open AccessBook
Randomization in Clinical Trials: Theory and Practice
Reads0
Chats0
TLDR
In this paper, the effects of bias bias bias on the allocation of treatment allocation in clinical trials are discussed, including the effect of unobserved covariates Selection bias Randomization as a Basis for Inference Inference for Stratified, Blocked, and Covariate-Adjusted Analyses Randomization in Practice Response-Adaptive Randomization Inference For Response Adaptive Rondomization Response Adaptation Randomization is used in Clinical Trials.Abstract:
Preface Randomization and the Clinical Trial Issues in the Design of Clinical Trials Randomization for Balancing Treatment Assignments Balancing on Known Covariates The Effects of Unobserved Covariates Selection Bias Randomization as a Basis for Inference Inference for Stratified, Blocked, and Covariate-Adjusted Analyses Randomization in Practice Response-Adaptive Randomization Inference for Response-Adaptive Rondomization Response-Adaptive Randomization in Practice Some Useful results in Large Sample Theory Large Sample Inference for Complete and Restricted Randomization Large sample Inference for Response-Adaptive Randomization Author Index Subject Indexread more
Citations
More filters
Journal ArticleDOI
Tucatinib, Trastuzumab, and Capecitabine for HER2-Positive Metastatic Breast Cancer.
Rashmi Krishna Murthy,Sherene Loi,Alicia Okines,Elisavet Paplomata,Erika Hamilton,Sara A. Hurvitz,Nan Lin,Virginia F. Borges,Vandana G. Abramson,Carey K. Anders,Philippe L. Bedard,Mafalda Oliveira,Erik Jakobsen,Thomas Bachelot,Shlomit S. Shachar,Volkmar Müller,Sofia Braga,François Duhoux,Richard Greil,David Cameron,Lisa A. Carey,Giuseppe Curigliano,Karen A. Gelmon,Gabriel N. Hortobagyi,Ian E. Krop,Sibylle Loibl,Mark D. Pegram,Dennis J. Slamon,M Corinna Palanca-Wessels,Luke Walker,Wentao Feng,Eric P. Winer +31 more
TL;DR: In heavily pretreated patients with HER2-positive metastatic breast cancer, including those with brain metastases, adding tucatinib to trastuzumab and capecitabine resulted in better progression-free survival and overall survival outcomes than adding placebo.
Journal ArticleDOI
Beyond the intention-to-treat in comparative effectiveness research
TL;DR: It is recommended that all randomized clinical trials with substantial lack of adherence or loss to follow-up are analyzed using different methods, including an intention-to-treat analysis to estimate the effect of assigned treatment and ‘as treated’ and ’per protocol’ analyses to estimateThe effect of treatment after appropriate adjustment via inverse probability weighting or g-estimation.
Journal ArticleDOI
Focal psychodynamic therapy, cognitive behaviour therapy, and optimised treatment as usual in outpatients with anorexia nervosa (ANTOP study): randomised controlled trial
Stephan Zipfel,Beate Wild,Gaby Groß,Hans-Christoph Friederich,Martin Teufel,Dieter Schellberg,Katrin Elisabeth Giel,Martina de Zwaan,Andreas Dinkel,Stephan Herpertz,Markus Burgmer,Bernd Löwe,Sefik Tagay,Jörn von Wietersheim,Almut Zeeck,Carmen Schade-Brittinger,Henning Schauenburg,Wolfgang Herzog +17 more
TL;DR: Focal psychodynamic therapy proved advantageous in terms of recovery at 12-month follow-up, and enhanced cognitive behaviour therapy was more effective with respect to speed of weight gain and improvements in eating disorder psychopathology.
Journal ArticleDOI
A Randomized Trial of Lymphadenectomy in Patients with Advanced Ovarian Neoplasms
Philipp Harter,Jalid Sehouli,Domenica Lorusso,Alexander Reuss,Ignace Vergote,Christian Marth,Jae Weon Kim,Francesco Raspagliesi,Björn Lampe,Giovanni Aletti,Werner Meier,David Cibula,Alexander Mustea,Sven Mahner,IB Runnebaum,B Schmalfeldt,Alexander Burges,Rainer Kimmig,Giovanni Scambia,Stefano Greggi,Felix Hilpert,Annette Hasenburg,Peter Hillemanns,Giorgio Giorda,Ingo von Leffern,Carmen Schade-Brittinger,Uwe Wagner,Andreas du Bois +27 more
TL;DR: Systematic pelvic and paraaortic lymphadenectomy in patients with advanced ovarian cancer who had undergone intraabdominal macroscopically complete resection and had normal lymph nodes both before and during surgery was not associated with longer overall or progression‐free survival and was associated with a higher incidence of postoperative complications.
Journal ArticleDOI
The risks and rewards of covariate adjustment in randomized trials: an assessment of 12 outcomes from 8 studies
TL;DR: Assessment of the impact of covariate adjustment on 12 outcomes from 8 studies across a range of therapeutic areas found that adjustment for known prognostic covariates can lead to substantial increases in power, and should be routinely incorporated into the analysis of randomized trials.