Small clinical studies for huge breakthrougs in cancer research

29 november 2016

Federa Award to David J. Stewart and Razelle Kurzrock.

A radical change in strategy for anticancer research was proposed by prof David Stewart  (University of Ottawa, Canada) und prof Rachelle Kurzrock (UCSD Moores Cancer Center, San Diego, California, VS) in 2009.  They proposed that clinical trials should aim to find large differences in small patients groups, and not small differences in large groups. Stewart and Kurzrock’s idea radically broke with traditional reasoning in medicine that led to slow tedious and too limited progress of anticancer treatment. Their concept has opened the way to personalized medicine. Therefore, the Federa Award was given to David Stewart and Rachelle Kurzrock by Leendert Looijenga, Federa Chairman, at 11th November 2016.  

Statistical significant or clinical relevant

Stewart and Kurzrock showed that many so-called successful therapies prolonged survival only for mere weeks, but were hailed for being statistically significant. They also showed that breakthrough medicines did have clear benefits in hard data, such as progression- or disease-free survival for at least 6 months. Clinical studies aiming for hard and large therapeutic differences in the results do not need to be randomized controlled, since placebo effects are never large in hard outcomes.

Simpler testing of more medicines

Stewart and Kurzrock argued that clinical research should focus at treatments that offer relevant differences in survival for the patients. If therapy has a large survival benefit for patients with a poor prognosis, pharmaceutical testing does not need inappropriately high safety testing – such testing would only slow progress. Reducing size and requirements of clinical studies allows the testing of many different agents in small numbers of patients for example grouped by biomarkers (personal medicine). The bold change of strategy was supported by research into the fate of FDA-approved oncology drugs for which no large randomized controlled trials have been performed.

How to make cancer research more clinical relevant

Go to the presentation -hyperlink volgt- 7 Messages by prof David Stewart at 11th November 2016, Radboudumc  Nijmegen

Key publication

DJ Stewart, R Kurzrock. 2009 Cancer The Road to Amiens. J. Clin. Oncol. 27:329-333

Go to Presentation DJ Stewart on FederaDay How to make cancer research more clinical relevant  7 Messages

Program Committee

The nomination for the scientific Federa Award was done by the Program Committee FederaDag.

Prof. Leendert H. J. Looijenga PhD, chairman Federa
Prof. Marco C. Harmsen PhD, board member Federa
John J. L. Jacobs PhD, secretary Federa
René J F Melis PhD, board member Federa; COREON
Gerard Swaen PhD, board member Federa; COREON
Jozien Helleman PhD, PostdocNL
Christina Helbig PhD, PostdocNL

Nobel Prize?

This year the prestigious Federa Award will be given to scientist for the 40th time. Four Federa award laureates, were awarded with the Nobel Prize, 1 to 25 years later. In lieu of the Federa Award Prof Stewart has given a lecture, November 11th at the Radboud UMC, Nijmegen, The Netherlands.  (link volgt)

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