New FDA clinical trials could make BC meds available much sooner

Anonymous

http://www.fdanews.com/newsletter/article?articleId=146786&issueId=15821

luv_gardening

Bringing drugs to market a decade earlier...  So understated.  Different drug combinations and timing of drug combinations would also be worth testing now.  All the possible breakthroughs we see on this forum come with a feeling of defeat at the amount of time required to get results, and that should end now.

We should be shouting from the rooftops.

Anonymous

Some Medical Oncologists think phase 3 trials should be eliminated, after all toxicity of meds is proven in phase 1,

phase 3 is time consuming and very expensive. The savings in eliminating phase 3 could be used to fund

at least three times the number of trials now being done,  thus possibly finding a cure 3 times faster.

Another thing is making the Expanded Access Program mandatory, right now its voluntary for pharmaceutical companies to participate , 

 many think this is what helped fast track HIV meds and turned it into a chronic disease

Husband11

How do they work around phase 3 trials?  The phase 3 is to determine efficacy.  How do we quantify success or failure without it?

Anonymous

http://biotechstrategyblog.com/2011/11/improving-cancer-clinical-trial-design-aacr-molecular-targets.html/

Anonymous

http://www.onclive.com/publications/Oncology-live/2012/April-2012/Going-Beyond-the-Label-Targeted-Therapies-Present-New-Questions-in-Clinical-Use/

jenrio

The classic 3 phase system is pre-genomic targetting of drugs.    Like the lymph-node-based staging system, is pre CTC and molecular genomic classification of breast cancer.    They are already outdated by new technologies.  It's like requiring everyone to file government paperwork by hand and hand it in on a horsedrawn carriage.   

We want these systems thrown out and speed up the drug development process, so that we can go for the cure sooner and cheaper cure.