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How to Succeed in Modernizing Clinical Trials

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Clinical trials are the lifeblood for those of us with CLL and the only way that our treatment has improved.

But clinical trial design is existentially flawed, leading to poor accrual and limiting the potential positive impact of the research.

This article from Oncology Times suggests creative and practical paths to improving clinical trials, echoing some of what we at the CLL Society have been promoting for years

Here are a few of the key take-aways:

  • ASCO’s TAPUR trial and the NCI-MATCH trial are leading the way with a trial design that links targeted cancer drugs to patients’ actionable mutations, rather than relying on tissue type. This is the future of personalized medicine.
  • Recognizing there is a need to redefine clinical trial eligibility to improve enrollment and to offer hope to more patients by allowing the inclusion of those with prior cancers that don’t influence outcomes. These patients are excluded from most trials now.
  • Including in trials even more patients whom today are routinely excluded because of brain metastases, minimum age, HIV/AIDS, and organ dysfunction.
  • Real world data mined from Electronic Health Records (EHR) and other sources is an increasingly valuable research tool.
  • To move drugs to patients more quickly, for an early phase trial where there is exceptional survival data, immediately submit for regulatory approval and at the same time start the necessary phase III to confirm the results. Here is link to information on the difference phases of clinical trials.

There is much more to this thoughtful and provocative article from Oncology Times:

http://journals.lww.com/oncology-times/Fulltext/2017/01100/How_to_Succeed_in_Modernizing_Clinical_Trials.9.aspx

Brian Koffman, MD  2/28/17

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