Is there a way that I can combine two PMCF studies into one?

Q

QARAM

My company has a medical device that was approved by the NB about six months ago. We wrote a PMCF for that device and that was OK'd by the NB. That PMCF had 100 patients or so to follow.

Today, we're trying to get a variant of that device to get approved by the same NB. We actually haven't launched the original medical device so the number of patients that use the device are limited.

Is there a way that I can combine two PMCF studies into one? Would I still be able to use 100 patients to follow? The variant of the device is close to identical to the original except for added pigments.

Thanks for any insight that is provided.
 

c.mitch

Quite Involved in Discussions
Hi
Your Pmcf was agreed by the NB. If you change it you have to bring proofs that changes won't impair the study.
How did you choose the size of your patient group? It is still relevant and statistically acceptable to change the size of the group or to separate the group in two sub groups with a different version of your product?
Other concern: what are the goals of your Pmcf in terms of device performance and safety? Does changing the study still allow to achieve these goals?
Many questions, though. It's hard to give advice with so few data.
 
Q

QARAM

I think I'll have to see if there is any benefit to combining them or what the statistical rationale would be if I made subgroups. The sample group was chosen with a study population equation with a 20% dropout rate. The objective of the study was to confirm clinical performance and safety for the indications for use over a period of three years. I was just wondering it combining the studies would be better than running the same exact one again, especially if the first one hadn't really started (less overall patients, etc.)

Thanks for your help!
 

c.mitch

Quite Involved in Discussions
If the first study hasn't really started then yes it could be relevant to reshape your PMCF.
That would be probably accepted by your NB.
Besides that it's up to you to define the best Pmcf strategy, still in line with its initial goal of confirming device performance and safety.
 

Michael Malis

Quite Involved in Discussions
I think I'll have to see if there is any benefit to combining them or what the statistical rationale would be if I made subgroups. The sample group was chosen with a study population equation with a 20% dropout rate. The objective of the study was to confirm clinical performance and safety for the indications for use over a period of three years. Thanks for your help!

Just remember to check your statistical rational and sample size is still valid for the combined study!
 
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