Why do so many companies run their clinical studies like driving with the car through the fog?
In no other industry can you find so many extremely smart people with excellent ideas to help patients, but when the clinical trial phase starts, many of those intelligent people start playing roulette. Millions of Dollars are spent to see at the end of the trial, if the results are positive in terms of efficacy and safety. If not, all money is gone. And errors during measuring or recording efficacy or safety can quickly turn a study heading the right way into one unable to show the desired outcome.
In most studies it is quite simple to get a better view into the data fog. Nowadays, statistical monitoring can show how our data look like during the whole course of the study and quickly identify spurious data or systematic errors before it is too late. Sponsor who use the foggy way of driving a clinical trial should not complain about the high risk of clinical research but think about more intelligent ways of conducting it. It is not enough to have smart people, people need to do smart things.
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