APRIL2014            The Oncology Consortia of Criterium Global CRO            Scholarly Commentary & Journal

Cancer Research Methods via the
Consortia Model 

From the Desk of...





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WHEN LESS IS MORE in Drug Development

Cancer clinical therapy development is moving beyond the classical clinical research trial paradigm used to develop new oncology treatments. This paradigm was based upon the sequential use of Phase I trials to define toxicity and tolerable doses and schedules.  Phase II trials then search for signals of efficacy in particular disease types.  Phase III trials complete the paradigm and are designed to test new therapies against the current standards of care. Therapies successfully completing the Phase I, II, and III trials are presented to regulatory agencies for approval as widely available cancer treatments.
Although there will always be a role for some drugs to be developed using the classic Phase I-III mechanism for development, many newer cancer treatments will be targeted not against a cancer type but rather against specific molecular targets that may be identified in cancers arising in various different organs. Therefore it doesn't make sense to do Phase I- III clinical trials in large number of patients with a histologically defined cancer (lung cancer, breast cancer, renal cancer, for example). Rather one needs to test the efficacy of a targeted therapy in tumors that carry the target of interest.

An example of this scenario is the HER2 target. HER2 was originally identified in breast cancer and a monoclonal antibody targeting HER2  (Herceptin) was developed and shown to be efficacious in HER2+ breast cancer. More recently HER2 was identified in about 20% of stomach cancers. Herceptin was shown to be active in HER2+ gastric cancer but not in the roughly 80% of tumors that were HER2-.
The gastric cancer HER2 story illustrates important points about targeted therapy development.  First, clinical trials taking all comers with a histologically defined cancer like stomach cancer makes no sense. The patient population chosen must be from the 20% of patients whose stomach cancers express HER2. Also full toxicity evaluations and dose finding studies do not need to be done since we have much of these data from the experience with Herceptin in breast cancer.

The bottom line here is that as we get increasingly more sophisticated in defining molecular targets in cancer, we will be dealing with smaller clinical trials performed in carefully defined patient populations. The molecular biology of the cancer and the targeted therapy will be come increasingly more important in cancer therapy development.


This Month's Guest:
Dr. John S. Macdonald

Senior Consultant for The Academic GI Cancer Consultant Consortium (AGICC) & The Academic Myeloma Consortium (AMyC) of The Oncology Consortia of CRITERIUM, INC. Global CRO

John S Macdonald MD

John S. Macdonald, MD, is Senior Medical Advisor for Criterium Inc. He served as Medical Director and Chief of Gastrointestinal Oncology at St. Vincent's Comprehensive Cancer Center in New York City from 1998-2007. Dr Macdonald is Board certified in internal medicine and oncology. In addition to his responsibilities at the Saint Vincent's Cancer Center from 1998 to 2007, Dr. Macdonald served as Chief of Medical Oncology at St. Vincent's Hospital and Medical Center, and Professor of Medicine at the New York Medical College.

Dr. Macdonald was named as the first recipient of an endowed professorship, the Lynn Wood Neag Distinguished Professor of Gastrointestinal Oncology, in 1999. He is recognized as a leading educator in Medical Oncology and has received numerous forms of recognition for his skills in medical education.

A leader in his field and a specialist in gastrointestinal cancer, Dr. Macdonald has authored more than 400 articles, abstracts and book chapters and has been published in many medical journals, including The New England Journal of Medicine, Cancer.


For more information on the consortia model for drug development in oncology trials,
please visit our webpages for AGICC and AMyC.

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