How to make cancer research more clinical relevant

02 december 2016

7 Messages on How to make cancer research more clinical relevant

by prof David Stewart at 11th November 2016, Radboudumc Nijmegen

  1. Delays in regulatory approval of effective new therapies come at a very high cost
    Time from drug discovery to approval:
    -1960s: 8 years
    -2000: 12.9 years (61%)

  2. Increasingly stringent clinical research regulation has had minimal impact on cancer patient safety

  3. Excessive regulatory stringency markedly increases clinical research costs, and this directly slows progress
    High research regulatory costs mean: Fewer ideas can be tested with available resources
  4. As a means of protecting patients, current regulatory stringency is not at all cost-effective
  5. We must tackle the numerous speed bumps on the road to approval of effective new therapies!
    Start by resetting the focus: Progress-Centered Regulation for clinical research in lethal diseases!!
    10 Areas that need to be addressed  - extensive evidence and clear solutions are given.

  6. Aim high, not low
    We have only gained little since RCTs are often specifically designed to detect small gains

  7. Identify the drug target, Select patients based on the target
    Common cancers are common since can be caused by many different mutations. One may need different treatments for each group of patients with cancers caused by different mutations
    - Braiteh & Kurzrock, 2007
    This is an international problem. We must all work together to fix this!
    “It’s not enough that we do our best; sometimes we have to do what’s required.” - Winston Churchill

    Life Saving Therapies Network 

    Download Stewart’s presentation FederaDag 2016- Focussing on clinical results - David J Stewart.pdf

    The Federa Award 2016 was handed over to David J. Stewart and Razelle Kurzrock at 11th November, Radboudumc Nijmegen.      Go to Small clinical studies for breakthroughs in cancer
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