Oral Presentation at American Society of Hematology (ASH) Annual Meeting Highlights Model to Dramatically Speed Clinical Trial Startup, Accrual, Completion
NORWALK, Conn.--(BUSINESS WIRE)--The Multiple Myeloma Research Consortium (MMRC) today presented compelling new results highlighting its success in accelerating the completion of clinical trials and the development of treatments for multiple myeloma, an incurable, but treatable blood cancer. In an oral presentation entitled, "The Multiple Myeloma Research Consortium (MMRC): Accelerated Start Up and Accrual Metrics Speeds Drug Development," the MMRC unveiled data demonstrating improvements in trial start-up and enrollment times as well as patient accrual for clinical trials run through the Consortium.
"Our goal is to drastically accelerate drug development timelines and get promising new treatments to patients as quickly as possible. We are grateful for each of our MMRC investigators who share this goal and whose dedication and work are critical to ensuring meaningful improvement and acceleration of clinical trials."
"We are working to break down the barriers that prevent timely completion of clinical trials in ways which we believe can serve as a model far beyond multiple myeloma," stated Kathy Giusti, Founder and CEO of the Multiple Myeloma Research Foundation (MMRF) and MMRC, and a myeloma patient. "Our goal is to drastically accelerate drug development timelines and get promising new treatments to patients as quickly as possible. We are grateful for each of our MMRC investigators who share this goal and whose dedication and work are critical to ensuring meaningful improvement and acceleration of clinical trials."
Key Data Presented in ASH Oral Presentation
Clinical trials in cancer are notoriously difficult to enroll and complete in a timely manner, which can delay or even prevent the development of potentially life-saving treatments for patients in need. The data presented are especially compelling in that industry standards show less than five percent of patients participate in oncology trials and timelines can be as long as two years to design, approve and activate a trial in the oncology field.1 2
The oral presentation highlighted key trial metrics data based on a retrospective review of 25 multiple myeloma trials conducted with MMRC project management resources from May 2006 to July 2011. The data also included comparisons between a set of baseline trials (June 2006 - September 2008) and recent trials (September 2008 - July 2011) run through the Consortium, with the recent trials based on the model the MMRC and MMRF have established to accelerate drug development.
* The recent trials opened 28% faster than the baseline trials, which opened at times consistent with industry standards3 (131 calendar days for recent trials vs. 181 calendar days for baseline trials);
* All MMRC trials opened 20% faster when comparing all participating MMRC centers on any MMRC trial (189 days for recent trials vs. 236 calendar days for baseline trials);
* MMRC trials enrolled 10% more patients than their pre-study enrollment commitment, with 89% of trials meeting their commitment; and
* MMRC trials enrolled patients 10% faster when compared to their baseline enrollment timeline, with 67% of trials meeting their pre-study enrollment commitment 34%, or 4.5 months, faster than their baseline enrollment timeline.
This model has benefitted drugs that have advanced into late stages of development, such as carfilizomib, pomalidomide and others that have shown promise against high-priority targets.
MMRC Business Solutions Addressing Challenges in Oncology Drug Development
The MMRC achieved these improvements through a number of targeted programs implemented at its 16 member institutions, and through direct collaboration with industry sponsors of clinical trials. Specifically, the MMRC has accelerated clinical trials through the following key initiatives:
* Scientific Leadership: an established team with decades of experience in drug discovery and development, along with a network of leading myeloma experts, to develop a strong portfolio of trials with promising treatments;
* The MMRC Project Management Network: a system to improve on-site project management and expedite the protocol, budget and IRB approval processes;
* Centralized Contracting: working centrally to coordinate with legal teams across multiple institutions and institute multi-party contract agreements to accelerate the clinical trial contract approval process;
* Protocol Quality Assurance: working with industry sponsors by reviewing proposed multiple myeloma protocols before distribution to FDA, and eventually, MMRC;
* MMRC Investigator-Sponsored Trial Platform: providing MMRC investigators with the ability to conduct multi-center trials with the same quality as company-sponsored trials;
As previously announced, MMRC has seven other oral presentations and abstracts at the ASH Annual Meeting, encompassing results from myeloma trials conducted with MMRC support and project management resources, which represent studies across the most promising areas of myeloma research and development.
About the Multiple Myeloma Research Foundation (MMRF)
Multiple Myeloma Research Foundation (MMRF) was established in 1998 as a 501(c)3 non-profit organization by twin sisters Karen Andrews and Kathy Giusti, soon after Kathy's diagnosis with multiple myeloma. The mission of the MMRF is to relentlessly pursue innovative means that accelerate the development of next-generation multiple myeloma treatments to extend the lives of patients and lead to a cure. As the world's number-one private funder of multiple myeloma research, the MMRF has raised over $170 million since its inception to fund nearly 120 laboratories worldwide, including 70 new compounds and approaches in clinical trials and pre-clinical studies and has facilitated more than 30 clinical trials through its affiliate organization, the Multiple Myeloma Research Consortium (MMRC). As exceptional stewards of its donors' investments, the MMRF has been consistently recognized for its sound fiscal management. For more information about the MMRF, please visit www.themmrf.org.
About the Multiple Myeloma Research Consortium
The Multiple Myeloma Research Consortium (MMRC) is a 509(a)3 non-profit organization that integrates leading academic institutions to accelerate drug development in multiple myeloma. It is led from MMRC offices in Norwalk, Conn., and comprises 16 member institutions: Barbara Ann Karmanos Cancer Institute, Baylor Charles A. Sammons Cancer Center at Dallas, City of Hope, Dana-Farber Cancer Institute, Emory University's Winship Cancer Institute, the John Theurer Cancer Center at Hackensack University Medical Center, Mayo Clinic, Ohio State University, Mount Sinai School of Medicine, Sarah Cannon Research Institute, University Health Network (Princess Margaret Hospital), University of California-San Francisco, University of Chicago, University of Michigan, Virginia Cancer Specialists, and Washington University in St. Louis.
The MMRC was founded in 2004 by Kathy Giusti, a myeloma patient, and with the help of the scientific community. The MMRC is a sister organization to the Multiple Myeloma Research Foundation (MMRF), the world's leading funder of multiple myeloma research. The MMRC is widely recognized as an optimal research model to rapidly address critical challenges in drug development and to explore opportunities in the today's most promising research areas in genomics, compound validation, and clinical trials. The MMRC is the only consortium to join academic institutions through membership agreements, customized IT systems, and an integrated tissue bank. For more information, please visit www.themmrc.org.
1 IOM (Institute of Medicine). 2010. A National Cancer Clinical Trials System for the 21st Century: Reinvigorating the NCI Cooperative Group Program. Washington, DC: The National Academies Press.
2 National Cancer Institute (http://www.cancer.gov/clinicaltrials/researchabout/developments/doctors-barriers0401)
3 D. Dilts and A. Sandler. (2006) Invisible Barriers to Clinical Trials: The Impact of Structural, Infrastructural, and Procedural Barriers to Opening Clinical Trials. J Clinl Oncol 24;28:4545-4551.
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