Chris Coffey is the director of the Clinical Trials Statistical and Data Management Center at the University of Iowa. Chris wrote to the Foundation to share his point of view on the†Phase 3 trial of bapineuzumab, or "bapi," a compound tested by Pfizer, Johnson & Johnson and Elan to target beta amyloid clumps. Earlier this week, we shared the perspectives of Claudia Garrido-Revilla, a clinical trial participant, and Todd Sherer, CEO of The Michael J. Fox Foundation for Parkinson's Research.
The Michael J. Fox Foundation is making an important point: Failed studies should not limit the ability to conduct future studies. It is easy to over-react when a drug study fails.†I think this is where you have to separate the science from the emotion.†I was not really surprised by the results of the failed Alzheimerís study. Maybe Iíve been in the research field too long, or Iím just a natural skeptic, but if I had to bet on any ongoing clinical trial Ė then I would bet that it would be negative.† And, unfortunately, I would be right way more often than I would be wrong (even when there is seemingly good pre-clinical and supporting data for the trial).†Of course, thatís part of the research process Ė trial and error.
I hope that together, we can help change the mindset that everyone needs to play Monday morning quarterback and lambast what went wrong whenever a trial fails.†Unfortunately, thatís just a frustrating part of the process to success.†Even though itís not the ideal situation, individuals with a disease should be somewhat encouraged when a trial fails! It means that some company was willing to take a risk to develop a treatment for that disease. If companies are not willing to take a risk unless they have a sure winner, we will never get anywhere.