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BLOG June 2018

"We are starting a Small Trial, so JUST FOR NOW, we ignore some of the (Imaging related) details until we have a "GO" decision for the larger trial."

The sentence above is not uncommon at start-up Biotech companies, but will appear to be a VERY EXPENSIVE LESSON when the device / drug appears succesful !!!

Some of the key elements which will suffer from that approach are in general: Site Imaging consistency, data completeness, unbiased outcomes, regulatory compliance, statistical power.

Regardless if the FDA / EMA will accept your small trial results, the limited attention for details at the start will VERY LIKELY BE CHALLENGED at some later point....

It will appear that the same approach for the small study can not be accepted (anymore) for the larger trial, so the PRECIOUS DATA acquired for the smaller trial can later not be added to the larger trial without substantial (costly) effort....

Take home lesson:
Start a small trial as if it's the large one
you have been dreaming off !

(When the above message gives you a flush, it's allways possible to seek for professional help in the "contact" section....)

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