Dear all,
We are developing a "new" medical device which shares the majority of its design with another of our products, currently CE marked and marketed. That new product will be intended for the same clinical indication.
We are now at the stage of defining the proper route for its clinical evaluation and we think that the demonstration of equivalence might be challenged by our NB. Altough the principle of operation and performance requirements are similar, the new product will achieve them with a different intensity of energy and will consequently induce a biological response slightly different. In a nutshell, almost equivalent but additional clinical data may be required to assess its conformity.
My question is, would it be possible to benefit somehow from these similarities to justify (based on stats or not) a clinical trial sample size lower than what is usually calculated with classical statistical methods ? The idea is to tell our NB: yes it is equivalent, and to be even more confident, here some "extra" clinical data.
The only content I've found related to that is the use of bayesian statistics which seems far from obvious and quite disruptive.
Thank you for your help,
Louis L.-
We are developing a "new" medical device which shares the majority of its design with another of our products, currently CE marked and marketed. That new product will be intended for the same clinical indication.
We are now at the stage of defining the proper route for its clinical evaluation and we think that the demonstration of equivalence might be challenged by our NB. Altough the principle of operation and performance requirements are similar, the new product will achieve them with a different intensity of energy and will consequently induce a biological response slightly different. In a nutshell, almost equivalent but additional clinical data may be required to assess its conformity.
My question is, would it be possible to benefit somehow from these similarities to justify (based on stats or not) a clinical trial sample size lower than what is usually calculated with classical statistical methods ? The idea is to tell our NB: yes it is equivalent, and to be even more confident, here some "extra" clinical data.
The only content I've found related to that is the use of bayesian statistics which seems far from obvious and quite disruptive.
Thank you for your help,
Louis L.-