MMRF PRESS RELEASES
Multiple Myeloma Research Consortium (MMRC) Activates Clinical Trials 30-40 Percent Faster Than Industry Standard
Research Model Breaks Down Barriers Slowing Drug Development
Norwalk, CT — June 18, 2009
The Multiple Myeloma Research Consortium (MMRC), an innovative research model comprised of a network of 15 academic Member Institutions across North America and leadership in Norwalk, Connecticut, today announced preliminary data from an analysis showing that clinical trials opened through its clinical trials network were activated 30 to 40 percent faster than comparable clinical trials in oncology. Based on the implementation of specific business solutions, particularly scientific leadership, standardized clinical contracts and on-site project management resources, the MMRC has been able to decrease by an average of 100 days the time from the development and finalization of the trial's protocol to actual patient enrollment.
"This accelerated activation rate may help make myeloma more attractive from a development process as well as de-risk the process for our industry partners," says Susan Kelley, MD, Chief Medical Officer of the MMRC. "With so many new investigational agents in cancer clinical trials and escalating pressures to speed the time to completion of clinical trials, the MMRC is committed to sharing risk with the companies and investigators focused on myeloma to ensure that new treatments are delivered to patients as quickly as possible."
"The MMRF and MMRC provide an end-to-end solution for biotech firms and pharmaceutical companies partners seeking to advance promising drug leads into clinical trials," said Susan Molineaux, Ph.D., Founder and Chief Scientific Officer, Proteolix, Inc. who has collaborated with the MMRC to advance two clinical trials through the MMRC's clinical trials network. "These new data underscore what Proteolix has already experienced in collaborating with the MMRC speed, efficiency, and results."
About the Analysis
Data on key activities related to clinical trial start-up were collected and analyzed from 12 Phase I and II clinical trials conducted within the MMRC clinical trials network from May 2006 to March 2009. The analysis demonstrated that the trials initiated during 2007-2008, following the implementation of business solutions were able to open to patient enrollment in an average of 158 calendar days — down from an average of 257 calendar days for trials initiated earlier in the history of the MMRC and consistent with published data about conventional experience with trial activation (Dilts and Sandler, JCO, 2006)). This acceleration represents a 30 to 40 percent time-savings in the rate at which clinical trials were activated. Data will be submitted for presentation at an international scientific meeting later this year.
About the Multiple Myeloma Research Consortium (MMRC)
The Multiple Myeloma Research Consortium (MMRC), a 509a3 organization, was founded in 2004 by Kathy Giusti, a myeloma patient and Founder and Chief Executive Officer of the Multiple Myeloma Research Foundation (MMRF), to champion collaboration with and integration across academia and industry — while introducing high levels of accountability into the research process from all involved in research and development.
At the core of the MMRC model is an Executive Committee, based in Norwalk, Conn., which provides strategic scientific and clinical oversight of the MMRC's drug development projects. The MMRC's Member Institutions include prominent multiple myeloma clinical research centers in North America: City of Hope, Dana-Farber Cancer Institute, Emory University's Winship Cancer Institute, the Cancer Center at Hackensack University Medical Center, H. Lee Moffitt Cancer Center & Research Institute, Indiana University, Mayo Clinic, Ohio State University, Roswell Park Cancer Institute, St. Vincent's Comprehensive Cancer Center of Saint Vincent Catholic Medical Centers of New York, University Health Network (Princess Margaret Hospital), University of Chicago, University of Michigan, University of California – San Francisco, and Washington University. The MMRC's collaborative model also includes a Tissue and Data Bank, which serve as a "bridge" between laboratory and clinical research conducted by the MMRC members and a vital resource in advancing MMRC clinical trials and correlative science studies.
As a results-driven organization, the MMRC has, to date, partnered with pharmaceutical and academic sponsors to facilitate 19 Phase I and II clinical trials of the most promising, novel investigational compounds and new potential combination treatment approaches for myeloma. MMRC clinical trials are designed to include correlative studies, to better understand what drugs are most effective in treating various sub-groups of patients with myeloma, laying the foundation for the eventual development of additional treatment options for patients with myeloma.
For more information, contact: