After years of declines, the pharmaceutical industry is experiencing a greater rate of success with its clinical trials in recent years, according to a new analysis.
Between 2012 and 2014, more than 11 percent of clinical trials succeeded, which meant compounds being tested survived the arduous journey from the laboratory to the pharmacy counter. This reversed a downward trend seen over the past 20 years, according to executives at McKinsey & Co., the consulting firm that conducted the analysis and does consulting work for drug makers.
Between 1996 and 1999, the cumulative success rate was 16.4 percent, but gradually began declining in subsequent years. From 2000 to 2003, 10.8 percent of trials succeeded before falling to 10 percent between 2004 and 2007, and then bottoming out at just 7.5 percent between 2008 and 2011.
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Thanks for this “top line” awareness. For those of us in R&D/Clinical Operations, more details would be interesting. Such as:
Who is doing better: CRO or Sponsor run trials?
Which therapeutic areas are seeing the success and which are not?
What parts of the world are doing better or is everyone in all countries showing the same improvement?
How does the success relate to the amount Sponsors are paying Investigators as the per-patient-grant?
Are the studies succeeding because the compounds are better or because the studies have been able to meet the enrollment goals?
Excellent points. Another way to increase the odds of success is to stay away from therapeutic classes that have a high failure rate in Phase 3 such as psychotropic drugs. Not one was approved in 2015, and this was at one time the leading class of prescription drugs.
I’d be curious to see how the use of cloud and other modern technologies in clinical trials might have impacted (and continue to impact) the increased success in clinical trials. In 2012, when success rates started rising, cloud-based electronic systems were being adopted to help improve efficiency, control, and compliance throughout studies.
Lisa, all of the new technologies can improve clinical trial execution and maybe expose a poor candidate earlier in development. About 30 years ago Dr. Leigh Thompson of Eli Lilly applied the term “fail fast” to clinical development. In the end it comes down to protocol development. It is a truism that an excellent protocol can make an average drug succeed, and a poorly designed protocol can make an excellent drug fail. Maybe some lessons are being learned.
Sorry folks but Merck is still the gold standard. When Roy Vagelos ran the company and Ed Scolnick ran R&D the success rate for phase 3 trials was 95% because extended Phase 2 trials were such that no compound advanced to Phase 3 unless there was a 95% probability of success.