Comments on: FDA Embraces Personalized Medicine http://www.scienceprogress.org/2009/02/fda-embraces-personalized-medicine/ Progressive approaches to science policy Sat, 13 Mar 2010 13:54:22 -0500 http://wordpress.org/?v=2.8.5 hourly 1 By: gpawelski http://www.scienceprogress.org/2009/02/fda-embraces-personalized-medicine/comment-page-1/#comment-4894 gpawelski Tue, 21 Apr 2009 18:45:01 +0000 http://www.scienceprogress.org/?p=1442#comment-4894 The Committee on Comparative Effectiveness Research Priorities should conduct a study to compare the effectiveness of various genetic and cell culture assay technologies for targeted as well as conventional cancer treatment. The purpose of the study would show what assay technologies really work. An individualized online clinical study that would be totally transparent. Every patient should know what happened to previous patients. Patient outcomes need to be reported in real-time, so patients and physicians can learn immediately if and how patients are benefiting from new diagnostics and therapies. Real-world studies are not being performed under real-world conditions. No one is publishing real-world studies, except private laboratories performing cell-based analysis, which can only do real-world studies, because their studies require fresh, viable specimen, which must be accessioned and tested in real-time under real-world conditions. The Committee on Comparative Effectiveness Research Priorities should conduct a study to compare the effectiveness of various genetic and cell culture assay technologies for targeted as well as conventional cancer treatment.

The purpose of the study would show what assay technologies really work. An individualized online clinical study that would be totally transparent. Every patient should know what happened to previous patients. Patient outcomes need to be reported in real-time, so patients and physicians can learn immediately if and how patients are benefiting from new diagnostics and therapies.

Real-world studies are not being performed under real-world conditions. No one is publishing real-world studies, except private laboratories performing cell-based analysis, which can only do real-world studies, because their studies require fresh, viable specimen, which must be accessioned and tested in real-time under real-world conditions.

]]> By: H Lewis http://www.scienceprogress.org/2009/02/fda-embraces-personalized-medicine/comment-page-1/#comment-4291 H Lewis Mon, 09 Feb 2009 20:57:02 +0000 http://www.scienceprogress.org/?p=1442#comment-4291 Great article. Some of the hurdles to implementing personalized medicine (data sharing and interagency coordination efforts) are addressed in the Genomics and Personalized Medicine Act. If we can get that passed, which is possible given the support that the Obama administration shows for science, research, and health reform, some of these problems will be mitigated. Great article. Some of the hurdles to implementing personalized medicine (data sharing and interagency coordination efforts) are addressed in the Genomics and Personalized Medicine Act. If we can get that passed, which is possible given the support that the Obama administration shows for science, research, and health reform, some of these problems will be mitigated.

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