Speeding Up Cancer Trials

December 14, 2011

By Bio-IT World Staff

December 14, 2011 | The Multiple Myeloma Research Consortium (MMRC) has been able to accelerate the clinical trials process by making improvements to trial start-up and enrollment as well as patient accrual for oncology clinical trials run through the Consortium. MMRC presented the data yesterday in an oral presentation at the American Society of Hematology (ASH) Annual Meeting. 

“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,” said Kathy Giusti in a press release. Giusti is 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.” 

Oncology trials are notoriously difficult to set up, enroll, and complete, often taking as long as two years from design to activation. Between May 2006 and July 2011, 25 multiple myeloma trials were conducted with MMRC project management resources. Trials conducted from June 2006 to September 2008 made up a set of baseline trials, with the subsequent trials serving as test cases for the MMRC's model to accelerate drug discovery.

The findings were encouraging.

  • The recent trials opened 28% faster than the baseline trials, which opened at times consistent with industry standards (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. 

To achieve these improvements, MMRC implemented several programs and practices at its 16 member institutions. The MMRC Project Management Network improved on-site project management and expedited the protocol, budget, and IRB approval processes. The MMRC Investigator-Sponsored Trial Platform gave MMRC investigators the ability to conduct multiple-center trials with the same quality as company-sponsored trials. MMRC coordinated legal teams across multiple institutions and instituted multi-party contract agreements to accelerate the contract approval process. Finally, MMRC established a scientific leadership team of myeloma experts and researchers with drug discovery and development expertise to develop a portfolio of trials with promising treatments.