My July 2015 article, “How to Cut Study Delays-Revisited;’ generated quite a bit of interesting feedback. However, since research has shown that 90% of all clinical trials experience significant delay, I was not surprised. Some people shared their version of one of the problems I had cited. Others called to recount their tales of clinical trials gone bad. A few offered solutions or strategies that I had not considered. What did surprise me was the concentration of troubled scenarios around one of two causes: incomplete protocol development or slow enrollment.
All clinical trials have a timeline, some more aggressive than others. However, I have yet to see one that did not increase the stress level of one or more members of the project team. When the inevitable problems occur, there is rarely enough time to pause all activities while the team determines the root cause. More often than not, a looming deadline reinforces the natural inclination to apply a Band-Aid and keep moving forward. The intention always is to revisit the situation at a later, less rushed date to develop a permanent solution — a vaccine, if you will — so that particular problem does not recur in future trials. Finding the time for that extra step in today’s pressured development environment is difficult.
The future dividends, though, make the effort a worthy investment. To further illustrate this point, I selected seven scenarios from those I received, together with the corresponding Band-Aid and my recommended vaccine.