National Cancer Institute and drug companies aim to speed up clinical trials

  | January 11 | Washington Post | See Original Here

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A squamous cancer cell, in white, is attacked by two T cells, in red, as part of an immune response. (Duncan Comprehensive Cancer Center at Baylor College of Medicine/National Cancer Institute)

[COMMENT: Very promising.  I hope that this includes drugs for pediatric cancers. ALAN]

The National Cancer Institute launched an effort Wednesday to speed up clinical trials by getting researchers quicker access to the drugs they want to test.

The NCI initiative creates a virtual “formulary” — a kind of clearinghouse — that initially will include 15 different medications donated by six manufacturers. The formulary will allow the institute to act as an intermediary between the drug companies and scientists at 69 NCI-designated cancer centers and to streamline the process by which researchers get the therapies.

The new system could be especially helpful to scientists who want to test combinations of drugs — which is where many cancer trials are headed.

It can take several months or longer for researchers to negotiate agreements with manufacturers, and the process can be even more protracted if multiple medications made by different companies are involved. The new public-private partnership, NCI officials said, will hold manufacturers to tighter timelines in deciding whether to provide drugs for proposed clinical trials.

James Doroshow, deputy NCI director for clinical and translational research, said the institute is negotiating with “a substantial number” of additional pharmaceutical companies, which could lead to double the number of drugs included by year's end.

Doroshow and other officials said they have long wanted to set up such a formulary, and the idea picked up momentum when it was made a priority as part of the Obama administration's “cancer moonshot” effort this year.

The officials said they applied lessons learned in conducting their big precision-medicine trial, NCI-Match, which tests various medications on people with specific genetic mutations. It took the government officials about a year to negotiate agreements to get the drugs used in that trial.

The drug companies involved in the new formulary are Bristol-Myers Squibb, Eli Lilly, Genentech, Kyowa Kirin Pharmaceutical Development, Loxo Oncology and Xcovery.

In a statement, NCI Acting Director Douglas Lowy said the initiative “will help researchers begin testing promising drug combinations more quickly, potentially helping patients much sooner.”