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NCI and drug manufacturers work to speed up clinical trial approval

The National Cancer Institute announced last week efforts to get the drugs needed for clinical trials to investigators faster. The NCI is doing this by working with drug companies to create tighter deadlines for the companies to decide whether to provide investigators with the drug(s) needed for clinical trials.

Typically, it can take several months or longer for investigators to negotiate agreements with the companies and can take even longer if multiple medications are involved – a method that an increasing number of investigators are using. The NCI is creating a “formulary” that will allow the NCI to act as the intermediary between the investigators at 69 NCI-designated cancer centers and the drug companies.

James Doroshow, deputy NCI director for clinical and translational research, said that the NCI is working with “a substantial number” of companies to create streamlined processes. This could lead to double the number of drugs included in clinical trials by the end of 2017.

The formulary has long waited to come to fruition, and Obama’s “cancer moonshot” initiative gave the idea momentum.

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

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