To implement innovative methods in early phase dose finding studies

Paris, France, October 23, 2014– ClinBAY and Professor John O’Quigley announce today that they entered into a scientific partnership in the area of innovative dose-finding methods in oncology. This collaboration will permit the broader dissemination of continual re-assessment and related methods1 (CRM) in early-phase oncology trials.

As Francois Vandenhende, Ph.D., chief executive officer of ClinBAY wrote:

Over the last few years, the demand for adaptive dose finding methods in oncology has surged. Our volume of work has grown and the complexity of studies increased. To respond to this challenge, we are very proud of having Prof. O’Quigley joining our team of statistical experts.

Professor O’Quigley will work in close partnership with ClinBAY statistical consultants and programmers, to enable the practical implementation of state-of the-art CRM type methods in clinical trials. Research and training programs will also be initiated to support this effort.
Prof. O’Quigley further commented the announcement as:

A really exciting opportunity for me to be involved in something that can only be described as a revolution in dose finding methods. The accuracy of early phase studies is increasing dramatically and will result in fewer failed Phase 3 studies. This can only be good news for developers and patients alike.

Established in 2007, ClinBAY is a global statistical CRO that provides innovative solutions for clinical trials. This involves consulting, programming and proprietary software products: Decimaker® for adaptive & Bayesian trials and ClinXPORT® for the automation of analysis and reporting with SAS®.

Professor O’Quigley is a mathematical statistician with extensive experience in the development of new methodologies for use in all phases of clinical trials. Currently at the University Pierre and Marie Curie, Paris and Research Director at Inserm, Dr O’Quigley has held academic appointments in several of the world’s leading biostatistics and mathematics faculties including the Fred Hutchinson Cancer Research Center, the University of Washington, the University of California at San Diego, the University of Virginia and Lancaster University in England.

1. O’Quigley J, Pepe M, Fisher L (1990). Continual Reassessment Method: A Practical Design for Phase 1 Clinical Trials in Cancer. Biometrics, 46(1), 33-48.

If you would like more information about this topic, please contact Francois Vandenhende, Ph.D. by email at

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