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New clinical trial format may boost cancer drug development

  • In a novel cancer study funded with $42M by Cancer Research UK, scientists will test up to 14 different cancer drugs at the same time within one clinical trial. The objective is to identify the most effective treatments for advanced lung cancer by targeting specific rare genetic mutations.
  • The new approach will select a range of drugs for a specific patient instead of designing a study around a specific drug. In a profound change it eliminates randomization, the hallmark of clinical trial design.
  • Some mutations occur on only 1% - 2% of patients so the traditional method of clinical trial design is too expensive, time-consuming and inefficient.
  • AstraZeneca (AZN) will supply up to twelve experimental drugs that will be given to patients who do not show one of twenty-one sets of genetic abnormalities.
  • Pfizer (PFE) will supply its lung cancer drug Xalkori plus the experimental breast cancer drug palbociclib.
  • About 15-20 patients will be involved in the trial. Those drugs that show no benefit will be quickly dropped while those showing efficacy will be fast-tracked into larger-scale testing.
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