The following is a guest post by Chad Parmet, a Research Associate with the Informed Medical Decisions Foundation. Chad gathers, evaluates and summarizes current medical research in support of new or revised Shared Decision-Making® programs. Before joining the Foundation, he worked as a medical writer. He holds a BA in physics from the University of Pennsylvania. In the past he reviewed many stories for HealthNewsReview.org. (The Foundation funds this project but has no control over what is published herein.)
Often I read that researchers have cooked up some new miracle drug that will change the world. But many of these miracles never materialize. That’s why one of the HealthNewsReview.org criteria rates articles on whether they’ve set appropriate expectations about the availability of the hot new thing.
But what should our expectations be for a drug that is still being tested?
Before a compound can make it onto a prescription pad, it must run a gauntlet of research studies in animals and humans. The FDA reviews the results and decides whether to approve it for use in Americans.
So I’ve been wondering: What are the odds that a drug in the middle of that gauntlet, generating headlines along the way, will ever make it our medicine cabinets?
I poked around PubMed, Google, and TRIP for evidence about those odds. I didn’t see any meta-analyses. I found a number of studies that used different estimates to produce the odds. Clearly, I can’t get a confident estimate of the odds without finding a solid, systematic meta-analysis of high-quality studies. That said, the estimates were in the same ballpark. And the ballpark was interesting.
The graphic below is my “gist” of the results from recent, peer-reviewed studies that—in my opinion—were most generalizable to small-molecule drugs seeking their first indications from the FDA.
Odds that a drug entering each phase of research
will ultimately make it to the market
Here are some important caveats about those numbers:
I could go on. This isn’t an academic study, just an exercise.
With these limitations in mind, the true gist I take from the exercise is that experimental drugs seem to have a lower likelihood of making it to the market than what I would expect from the revolutionary tone used in the typical news coverage of the next miracle drug.
I’d love to know if there’s a formal meta-analysis, or a better summary of the literature, that I missed. If you know of one, please leave a comment below.
Disclaimer: All of the research and conclusions presented are my own and do not represent the views and opinions of my employer, the Informed Medical Decisions Foundation.