As the federal government creates a plan to speed the pace of drug development in the U.S., one specialty contract research organization suggests that a more modernized approach to clinical trials ought to be a key part of the proposal.
With Memorial Day 2015 as it’s deadline, the House Energy and Commerce Committee is feverishly working toward a 21st Century Cures Initiative bill that would accelerate new cures and medical breakthroughs.
The committee seeks to broadly collaborate with the National Institutes of Health (NIH), Food and Drug Administration (FDA) and other agencies, as well as the nation’s patients and scientific pioneers in academia and industry.
The bipartisan group, which kicked off the project in April of 2014 with a series of hearings, discussions and roundtables, recently released a nearly 400-page discussion document. Chaired by Republican Rep. Fred Upton of Michigan and Democratic Rep. Diana DeGette of Colorado, the initiative has gained a fair amount of press for its push for the use of innovative diagnostics, advancements in molecular biology and novel bioinformatics to find new therapies.
This government effort is most certainly worthwhile. There’s no doubt that the industry must find ways to lower drug development costs and accelerate approvals. A recent study from the Tufts Center for the Study of Drug Development found that costs to bring a drug through development and successful regulatory approvals has reached an average of $2.6 billion — more than three times higher than the group’s 2001 estimate.
Specialty CRO Novella Clinical points out in a recent blog post that the best way to accelerate development timelines and reign in costs may be to improve the clinical research process.
“As an industry, we still rely on outdated best practices that no longer meet the needs of today’s trials and clinical programs,” the company noted. “Couple that with heavy regulatory challenges and it’s no wonder drug development timelines and costs continue to rise.”
Seems the FDA is taking note of this, as it looks to establish master protocols to cut down on the waste overrunning the clinical trial industry. Right now, global trials are run with different investigators and once the trial is over, it gets shut down.
According to Janet Woodcock, director of the FDA’s Center for Drug Evaluations and Research, with master protocols in place, trials would in essence remain open allowing numerous investigational devices to be evaluated at once and over time to help cut down on trial start-up inefficiencies. Novella added that such protocols would allow drug developers to compare data across different drugs in a way that has not been done in the past.
Novella also recommends making improvements to current institutional review board (IRB) processes to speed study start-up timelines.
It will certainly be interesting to see what comes out of the 21st Century Cures Initiative, particularly in regards to how it may integrate with President Obama’s Precision Medicine Initiative. But even as the details are being worked out, we’d like to see the FDA heed the advice of industry experts and find ways to improve clinical trial processes now.