time from phase IIb to phase 3 trials?

[pcds]

I posted this before, anyone know the timeframe?  I'm wondering because in phase 3 of some trials that will take people who have been in treatment before.  There's lots of exciting stuff in phase 2b.
Judy

[pcds]

Thanks for the thoughtful response.

[HectorSF]

Drug time-line? It depends on many factors..

Overall drug development process on average to bring one drug to market takes 12-15 years

Pre-clinical testing takes 1-3 years, on average 18 months

Clinical research (phase I-III) takes 2-10 years, on average 5 years

A single clinical trial in phase II-III will typically take anywhere from 1 year to 7 years from conceptual to publication) depending on therapeutic area and duration of individual subject participation.

Phase II

Phase II trials involve testing a small number of volunteer patients, typically 100 to 200 people who suffer from the targeted disease or condition, to determine the drug’s effectiveness and dose response relationship. This phase of the drug development process lasts an average of one to two years.  

A phase III study in acute pain may be completed within 6 months whereas a study in PD looking for neuroprotection may take more like 5-7 years.

NDA review takes 2 months to 7 years (on average 24 months)
Fast Track ~ 6 months

FDA approved 24 first of kind drugs in 2008 (vs. 18 in 2007, 22 in 2006 and 20 in 2005 (WSJ 1/2/2008). FDA missed the approval deadline for 32 out of 159 drug applications through 10/31/2008.

Patents are good for 17 years..companys want to maximize their ability to have have an exclusive market for as long as possible, thus adhering to realistic yet stringent timelines is essential for drug development

As individual researchers you may be faced with different types of pressures that will require adherence to a realistic timeline including: limited funding, need to publish to advance career, creating better treatments for your patients etc.

Today, its all about bringing products to market, and compressing drug development timelines is critical to focused product development and commercialization.  Identifying, integrating and implementing cost effective development, regulatory, and quality strategies is a challenge for new firms especially those with biopharmaceutical and combination products.  It takes broad experience, a solid understanding about how to deliver,  knowledge of the latest strategies, and an ability to integrate a total system approach which delivers results. 

While there has been lots of emphasis over the past several years to reduce the length, cost and risk of drug development there has been limited success in this area.

Hectorsf