Clinical trials of new anti-cancer therapies have often excluded patients whose disease has spread to the brain or central nervous system (CNS) or, if such patients were allowed on trial, trials have often failed to clearly capture information on the drug's effect in the brain. Today new guidelines from an international, multidisciplinary group published in the journal Lancet Oncology describe how to most appropriately address cancer patients with CNS involvement within clinical trials of anti-cancer drugs.
"Two major situations needed to be optimized. Firstly, as we've actually started to see some new anti-cancer drugs working well inside the brain, we needed to find a way to appropriately include these patients in clinical trials so that the trials could accurately capture that benefit. And secondly, for drugs that would be unlikely to work in the brain, we needed to limit risks to patients and to the drug development process," says D. Ross Camidge, MD, Ph.D., Joyce Zeff Chair in Lung Cancer Research at the University of Colorado Cancer Center, director of Thoracic Oncology at the CU School of Medicine and the lead author of the trial design guidelines.
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