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Restrictions on clinical trials impede drug development
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Most patients with cancer are treated with drug combinations, but researchers cannot test combinations in clinical trials unless both drugs have been approved by the FDA.
This situation becomes even more complicated when researchers want to evaluate combinations involving targeted therapies manufactured by different pharmaceutical companies. Business, legal, liability and intellectual property issues can all stand in the way when researchers are trying to design a trial involving multiple investigational drugs made by multiple manufacturers.
These conditions are frustrating and keep patients from getting access to potentially life-saving treatments, according to Janet Woodcock, MD, director of the Center for Drug Evaluation and Research at the FDA. She said the FDA recognizes the promise of molecularly targeted therapy and the need to find ways to conduct trials evaluating two or more investigational drugs together as anticancer agents.
“There are many barriers that exist to rapidly finding new interventions based on the new science and translating them into treatments and cures for cancer,” Woodcock said. “It’s clear that the existing paradigms are not going to be sufficient to translate this promise into cures for patients or effective treatments. They are too slow, too sequential, and we need to uncover better pathways.”
Woodcock was among a crew of experts, including representatives from government, industry and academia, who gathered May 4 at The Ohio State University to take part in the Cancer Drug Development Roundtable. The group’s stated goal is to “develop recommendations to the FDA, to make co-development of two or more experimental drugs a reality, (and) bringing better cancer treatments from microscope to market.” OSU plans to release those recommendations later this year.
The FDA released a draft guidance document in December providing recommendations for addressing the scientific and regulatory issues that arise during co-development of two or more experimental drugs. However, industry has not figured out how to make that a reality, said Michael Caligiuri, MD, CEO of the James Cancer Hospital & Solove Research Institute and director of The OSU Comprehensive Cancer Center.
There are plenty of scientific, logistical, competitive and regulatory stumbling blocks in the way, according to James H. Doroshow, MD, of the division of cancer treatment and diagnosis at the NCI, including a lack of assays, imaging tools, commercially available agents formulated for in vitro use and available investigational agents for in vitro use, in addition to the complexities of clinical trials and the various business and intellectual property concerns.
Ultimately, it will take cooperation among all the stakeholders to develop new therapies and deliver them to patients safely and efficiently, said Ellen Sigal, PhD, chairwoman of Friends of Cancer Research, a think tank and advocacy organization based near Washington, D.C.
“We’re going have to get sectors working together. This is too complicated,” Sigal said. “If we do it in a silo-ed approach, we’re not going to get there. We have to find out where we can work together, and scientifically, there are a lot of ways to do that. Hopefully, there’s enough to come out of today in terms of approaches, and there are multiple vehicles. We can’t advance this important science without collaboration.” – by Jason Harris
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