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Fady Khalla started the topic Multi-Center Clinical Studies in the forum Introduction to Advanced Medical Device Development 9 years ago
As we all have learned from Dr. Simon’s lecture this week. There are multiple types of clinical studies, including:
1- prospective
2- retrospective
3- Blinded
4- Randomized
5- placebo controlled
6- Multi-CenterThere are many advantages of doing a clinical study with any of the methods mentioned above. The multi-center clinical studies looks like it can do both good and harm for the clinical study results. Having multiple centers included in your study will help understand variability and provide a better proof that the device safe and effective even under different variations.
on the other hand, too many centers can distort the data and introduce so many variables. this could render the data to inconsistent.
In your opinion, where should the line be drawn? how many centers are considered too many? How many centers are considered sufficient to determine variability?