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Combined Trial

  • 3 August 2022
  • 4 replies
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Dear all, do you have experience with combined trial (where the object of the evaluation is 2 different products: a drug and a medical device)? Are 2 different protocols required? In which way the 2 submissions are linked and how the 2 different regulatory authorities communicate the outcome of the 2 applications, do we need 2 different approvals?

Thank you very much,

Silvia Ronchi

 

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Best answer by steven.poon 4 August 2022, 12:38

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Hi Silvia,

 

I don’t have any direct experience of your exact case for a combined trial, but suspect it may follow similar approaches to combination products. What is the primary mode of action (PMOA) between the medical device and the drug product, and would it indeed be considered as a combination product (co-packed, cross-labeled or otherwise)?

I suspect that whichever is the PMOA will determine if the protocol and eventual submission would go to: CDER, CBER or CDRH. The assigned centre will then liaise internally with their colleagues for the relevant drug/ medical device aspects.

If it is conducted in the same study with the same or coupled end points, then again I suspect you’d only need the single protocol.

 

If, however, they are indeed two separate regulated products and not considered as a combination, then they will likely need their own approvals.

 

Hope this helps to inspire some further thoughts or discussion on this.

 

Best regards,

Steven

Thank you very much, very helpful!

 

Hi Silvia,

I notice that my response is a bit late since you asked your question 5 months ago, but I wanted to add to the answer of Steven, that here in Europe and more specifically in The Netherlands, you are able to submit 1 protocol in which a medical device and drug are being evaluated. Since here the competent authority is one door, once submitted and carefully explained the situation at hand in the submission letter, they will arrange the logistics for review themselves. Which means, that first they will have their Ethics Committee specialized in drug studies review that part of the trial and in addition the medical device specialists are reviewing the device part. Sometimes this is done in sequence, but I also saw them reviewing in parallel. 

With the European CTR and MDR it is getting more complex as you have the upcoming EUDAMED portal (medical device) as well as the CTIS portal (drug) and it is at this stage not yet known how to submit your trial if you have both a device and drug (not a combination product) included in one trial. We are awaiting guidances on this and my advice is to discuss this with the countries where you would like to submit. 

From a US point of view I have no experience how this is handled. 

 

Good luck and I would love to hear any feedback once you have gained more knowledge on this.

Thank you very much, let’s follow the progress when the new guidance documents will be released.

Kind regards, Silvia

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