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AGICC: The Academic GI Cancer Consortium

 

Translational Science

The Consortia Model improves and advances research outcomes

The most important conceptual difference between the classical clinical trial and the consortia approach is that the Consortia Model, with its highly experienced clinical scientists, is involved on an intellectual advisory level with every step of clinical investigation in a GI cancer study. Classical clinical trials groups "just run the study" with their only substantive role being patient accrual.

Translational science is motivated by the need to provide effective treatments to the right patients at the right doses for a specific disease indication. The term, as used in the health sciences, refers to real-time translation of bench science conducted only in a lab, to bedside clinical practice with eventual dissemination to population-based community interventions. (Source: NIH)

The discipline of clinical and translational science encompasses a broad spectrum of research, extending from basic discoveries with implications for human health to community-based epidemiologic and health services studies. The unifying theme is a commitment to apply scientific methodologies to address a health need. SCTS (The Society for Clinical and Translational Science) defines it as:

"...a multi-dimensional, cross-cutting discipline that encompasses multidisciplinary investigative teams from many different subspecialty areas. Moreover, success in clinical and translational science commonly requires constructive partnerships with industry, granting agencies, public health agencies, and regulatory agencies. "

For more information on how the Consortia Model applies translational science to successful research outcomes, please contact John S. Macdonald, MD at: jsmacdonald@criteriuminc.com

ACTIVITY Clinical Trials Group Consortia Model
Concept Developed by Sponsor Developed by Sponsor in consultation with Consortia "Brain Trust/Virtual Advisory Board"
Protocol Written by Sponsor Written by Consortia with Sponsor
FDA/Regulatory Agency Contact Done by Sponsor Consortia functions as "Virtual Advisory Board" to help Sponsor with FDA/Regulatory issues
Translational science with clinical outcomes Little or NONE Consortia interfaces translational science with clinical outcomes and can show the value of translational science to a positive outcome of regulatory approval process*; consortia institutions have capability to collect tissue and access to labs to analyze and interpret data; consortia sites were selected for their access to patients with specific diseases and for their ability to enroll such patients on clinical trials.
Role of Investigators Accrue patients to established protocol The consortium investigators are the "Brain Trust“ – clinical scientists who are not only involved in the conceptual design of trial, but also are actively enrolling patients to a trial. **
Role of investigators in result analysis/ interpretation NONE Consortia puts the whole package (clinical & translational science) together into a coherent whole which clarifies the value of this package to the regulatory approval process along with providing comprehensive information to the sponsor to facilitate go-no go decisions.

*Interfacing clinical & translational science is critical to the Consortia’s contribution to research projects.
**Throughout the clinical trial the Consortia contributes ideas and experience.

 

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