Detection of Atypical Data in Multicenter Clinical Trials Using Unsupervised Statistical Monitoring

The Bigger Picture of the ICH E6 (R2) – Looking Beyond Compliance

This article is taken from Journal for Clinical Studies, page 23. 

ICH E6 (R2) – Miracle Pill for the Clinical R&D Industry

By Steve Young

ICH E6 (R2) Guideline – More than Ensuring Compliance – DIA Global Forum (Page 12)

By Steve Young

Hindering Hazards: CluePoints CCO Talks to ICT About New Approaches in Trial Quality Maintenance – ICT

This article is taken from International Clinical Trials November 2017, pages 44-45. © Samedan Ltd.

Statistical Monitoring of Data Quality and Consistency in the Stomach Cancer Adjuvant Multi-Institutional Trial Group Trial 

By Catherine Timmermans, Erik Doffagne, David Venet, Lieven Desmet, Catherine Legrand, Tomasz Burzykowski and Marc Buyse

Data-Driven Risk Identification in Phase III Clinical Trials Using Central Statistical Monitoring 

By Catherine Timmermans, David Venet and Tomasz Burzykowski

Fraud in Clinical Trials: Complex Problems, Simple Solutions?

By Junichi Sakamoto and Marc Buyse

The Role of Biostatistics in the Prevention, Detection, and Treatment of Fraud in Clinical Trials

By Marc Buyse, Stephen L. George, Stephen Evans, Nancy L. Geller, Jonas Ranstam, Bruno Sherrer, Emmanuel Lesaffre, Gordon Murray, Lutz Edler, Jane Hutton, Theodore Colton, Peter Lachenbruch and Babu L. Verma 

Impact of On-Site Initiation Visits on Patient Recruitment and Data Quality in a Randomized Trial of Adjuvant Chemotherapy for Breast Cancer

By J-L Lienard, E Quniaux, E Fabre-Gullevin, P Piedbos, A Jouhad, G Decoster and M Buyse

A Statistical Approach to Central Monitoring of Data Quality in Clinical Trials 

By David Venet, Eric Doffagne, Tomasz Burzykowski,  Francois Beckers, Yves Tellier, Eric Genevois-Marlin, Ursula Becker, Valerie Bee, Veronique Wilson, Catherine Legrand and Marc Buyse

Centralized Statistical Monitoring as a Way to Improve the Quality of Clinical Data

By Marc Buyse

Linear Mixed-Effects Models for Central Statistical Monitoring of Multicenter Clinical Trials

By  L. Desmet, D. Venet, Eric Doffagne, C.Timmermans, T. Burzyknowski, C. Legrand and Marc Buyse

Sequential Paclitaxel Followed by Tegafur and Uracil (UFT) or S-1 Versus UFT or S-1 Monotherapy as Adjuvant Chemotherapy for T4a/b Gastric Cancer (SAMIT): A Phase 3 Factorial Randomised Controlled Trial

By Akira Tsuburaya, Kazushiro Yoshida, Michiya Kobayashi, Shigefumi Yoshino, Masazumi Takahashi, Nobuhiro Takiguchi,  Kazauki Tanabe, Naoto Takahashi, Hishori Imamura, Naokuni Tatsumoto, Akinori Hara, Kazuhiro Nishikawa, Ryoji Fukushima, Isao Nozaki, Hiroshi Kojima, Yumi Miyashita, Koji Oba, Marc Buyse, Satoshi Morita and Junichi Sakamoto

Data Fraud in Clinical Trials

By Stephen L. George and Marc Buyse 

Use of the Beta-Binomial Model for Central Statistical Monitoring of Multicenter Clinical Trials 

By David Venet, Erik Doffagne, Catherine Timmermans, Catherine Legrand, Tomasz Burzykowski and Marc Buyse

A Hercule Poirot of Clinical Research 

By Junichi Sakamoto

Ensuring Trial Validity by Data Quality Assurance and Diversification of Monitoring Methods

By Colin Baigent, Frank E Harrell, Marc Buyse, Jonathan R Emberson and Douglas G Altman