‘Master protocol’ aims to revamp cancer trials

clinicalIn the push to match medical therapies to the genetic underpinnings of disease, lung-cancer treatments have been at the frontier. But the 1.6 million people diagnosed with this cancer every year will take scant comfort in knowing that of the past 20 late-stage trials of drugs to treat it, only two yielded positive results. And in only one of those 20 were patients chosen systematically by screening for biomarkers such as relevant blood proteins or DNA sequences.

Now, an ambitious project aims to improve those success rates and speed new treatments to market by matching companies with the patients whose tumours are most genetically relevant to the therapies they are trying to develop. The project is slated to launch next year and, if successful, could be expanded to other cancers.

The project was spearheaded by the Friends of Cancer Research, a think tank and advocacy group in Washington DC, and has won the support of the US National Cancer Institute and the US Food and Drug Administration (FDA). The idea is to streamline the drug-approval process by bringing pharmaceutical companies together to test multiple experimental drugs in late-stage clinical trials under a single, ‘master’ protocol. “The drive is to make the whole process of personalized medicine more efficient,” says Eric Rubin, vice-president of oncology clinical research at Merck, a pharmaceutical firm based in Whitehouse Station, New Jersey.

Click here to read more from this June 12, 2013 Nature article by Heidi Ledford.

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