Wednesday, July 18, 2012

Pill of progress: what are the chances of a drug becomes for the market?

The following is a guest post by Chad Parmet, a research associate with the Foundation for informed medical decisions.  Chad meets, assesses and summarizes the current medical research to support decision-making programs shared ® new or revised. Prior to joining the Foundation, he worked as a medical writer. He holds a Bachelor's degree in physics from the University of Pennsylvania. In the past, he revised many stories to HealthNewsReview.org. (Foundation is funding this project, but has no control over what is published here).


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Many times I read that researchers have cooked some new wonder drug that will change the world. But many of these miracles never materialised. That is why one of the criteria HealthNewsReview.org rates articles on if they ever set appropriate expectations about the availability of the hot new thing.


But what should be a drug that is still being tested our expectations?


A compound can do it in a prescription, it must run a gauntlet of studies in animals and humans. FDA analyzes the results and decide whether to approve it for use in Americans.


So I've been thinking: what are the chances that a drug in the midst of this challenge, generating headlines along the way, will never make it our medicine cabinets?


I poked around Google, PubMed and trip to evidence about these probabilities. Haven't seen any meta-analyses. I found a series of studies that used different estimates to produce chances. Clearly, I can't make a reliable estimate of the odds without finding a solid, systematic meta-analysis of studies of high quality. That said, the estimates were at the same level. And the stadium was interesting.


The chart below is my "essence" of the results of the recent, reviewed studies that — in my opinion — were more generalizable to small-molecule drugs that seek their first indications of the FDA.


The odds that a drug to each phase of the research
will eventually make it to the market


 

The essence of Adams Bratner & Davis et al 2006, 2011, DiMasi et al 2010, Kola & Landis 2004 and Paul et al 2010


Here are some important caveats about these numbers:


I could go. This is not an academic study, just an exercise.


With these limitations in mind, the true essence of exercise is that I take experimental drugs seem to have a lower likelihood of doing so on the market than what one would expect from the revolutionary tone used in typical news coverage next miracle drug.


I would love to know if there is a formal meta-analysis or a summary of the best literature, that I missed. If you know of one, please leave a comment below.


Chad Parmet

Disclaimer: all searches and conclusions are my own and do not represent the views and opinions of my employer, the basis of informed medical decisions.



 

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