Clinical Trial Requirement - No equivalent devices in the market

Prash

Registered
#1
We are manufacturing a class II B medical device that does not have any equivalent devices in the market; we are in the clinical trial phase and wondering how many recordings we should take with this patient monitoring device to show sufficient data for safety and effectiveness? We want to apply for CE marking.
 
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Raisin picker

Involved In Discussions
#2
There are mathematicians/statisticans out there that make a living by telling you exactly the number of patients per protocol you need to address a specific question. The number depends on your device, the type of intervention, comparators, indications, ... Noone can give you a number without much more details (more than you would want to share here).
Best guess: start with a low number of patients in a pilot trial (first in man, explorative trial). Then you can use the data gathered to get a better idea how many patients you need for your confirmatory trial, and what endpoints to define.
The NBs evaluator will want to see an explanation/calculation of your study population. By the way, you can ask your NB for a project meeting and discuss the studies you are planning. They cannot counsel you, but they might tell you when you're far off the mark.
 

Prash

Registered
#3
There are mathematicians/statisticans out there that make a living by telling you exactly the number of patients per protocol you need to address a specific question. The number depends on your device, the type of intervention, comparators, indications, ... Noone can give you a number without much more details (more than you would want to share here).
Best guess: start with a low number of patients in a pilot trial (first in man, explorative trial). Then you can use the data gathered to get a better idea how many patients you need for your confirmatory trial, and what endpoints to define.
The NBs evaluator will want to see an explanation/calculation of your study population. By the way, you can ask your NB for a project meeting and discuss the studies you are planning. They cannot counsel you, but they might tell you when you're far off the mark.
We know that statistics will help with number of patients.
But we want to know the number of reading we should take per patient? Is there any guidance for this?
 

RAQA Support

Supporting your goals and objectives since 1989.
#4
The number of readings per patient are determined by the device and the number of variables you are measuring. Since this is a unique device, you are most likely going to need to do more than expected because you have no comparator. This will need to be justified by a statistician as @Raisin picker stated. My recommendation would be to find a device that is similar to yours (or each of the device variables separately) and use their clinical numbers as a starting point.
 
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