Blood cancer group lights way to 28% faster trial starts

Researchers haven't figured out how to completely wipe out or cure blood cancers called multiple myeloma that infiltrate plasma cells, but the nonprofit Multiple Myeloma Research Consortium (MMRC) has advanced a slate of initiatives that were able to speed up how fast clinical trials for treatments against the chronic disease got started and enrolled patients. Slow trial start-ups and poor study enrollment are notorious roadblocks to testing new cancer treatments.

The MMRC-run clinical trials started 28% faster than other studies, taking 131 days to open compared with 181 days, the group said in a release (the data were also presented at the American Society of Hematology meeting in San Diego). And the group's trials rounded up patients 10% faster than other studies enrolled participants. The MMRC compared the studies it ran from September 2008 to July 2011 with baseline studies that took place from June 2006 to September 2008.

The nonprofit shared its strategy for beating the norm for getting trials up and running. Its numbers benefited from promising treatments such as Onyx Pharmaceuticals' ($ONXX) experimental cancer drug carfilzomib. Other initiatives included a project-management network to speed protocol, budget and institutional review board (IRB) approvals; centralized contracting involving legal teams from numerous institutions coordinating efforts and securing multi-party pacts to expedite the clinical trial approval process; and working with industry sponsors on trial protocols before presenting them to the FDA.

"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. "Our goal is to drastically accelerate drug development timelines and get promising new treatments to patients as quickly as possible."

Giusti, a myeloma patient, has been working on ways to accelerate the development of drugs against her disease since the late 1990s. She's up against some well-known hurdles in cancer drug development such as abysmal participation in studies among cancer patients, less than 5% of which take part in trials. Plus, there's a lot of regulatory paperwork and approvals that can slow the opening of a trial.

- here's the group's release
- see the summary in Bio-IT World