what percentage of clinical trials ultimately result in an effective drug?

I know it takes a while to go through with a clinical trial (10-15 years?) but how many of those clinical trials fail and how many result in production of a drug?

Thank you!

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Best Answer: About seven to fifteen years. The shortest time I've ever heard of a drug going from lab to actual use was the original HIV protease inhibitor, at the time there was essentially no treatment for HIV/AIDS, and a diagnosis usually meant death in under a year. The FDA basically pulled out all the stops for it.There's three phases of clinical trials, and precliical before that. The overwhelming majority of drugs die in preclinical trials. About 7-9% of what gets into Phase I trials gets to move forward. It's hard to go with an exact number, because high throughput drug screening - which is where they test a very large number of compounds looking for a specific behavior skews it. Of he compounds that are looked at seriously though, easily under 1% make it to the point where they can be sold.

2 Comments

  • Andy
    January 11, 2009 | Permalink |

    As pharmaceutical companies are not required to publish negative outcomes, finding the kind of data you are asking for will take a lot of fishing. Clinical trials have to be registered with the FDA (or the company etc. will not get approval to market the drug). Go to the site below to start your trip. Because clinical trials are so expensive (including the extensive R & D that precedes the trials) companies or individuals are usually confident that the drug or apparatus or whatever will at the very least not kill anyone during the trial and will work at least as well as whatever drug etc. is presently on the market. I’m going to star this question in case someone knows exactly how to get through the FDA maze.

  • Az R
    January 11, 2009 | Permalink |

    About seven to fifteen years. The shortest time I’ve ever heard of a drug going from lab to actual use was the original HIV protease inhibitor, at the time there was essentially no treatment for HIV/AIDS, and a diagnosis usually meant death in under a year. The FDA basically pulled out all the stops for it.

    There’s three phases of clinical trials, and precliical before that. The overwhelming majority of drugs die in preclinical trials. About 7-9% of what gets into Phase I trials gets to move forward. It’s hard to go with an exact number, because high throughput drug screening – which is where they test a very large number of compounds looking for a specific behavior skews it. Of he compounds that are looked at seriously though, easily under 1% make it to the point where they can be sold.

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