AMA on Clinical Investigations

  • 27 May 2022
  • 4 replies
  • 62 views

Userlevel 5
Badge

This week we’ve invited Jón Ingi Bergsteinsson & Páll Jóhannesson from Smart Trial for an exclusive AMA (ask me anything) session on the topic of the Clinical Investigations.

If you have run into problems, send a message directly to @Etienne and let us know!


4 replies

Q: How can data from clinical trials be used to support a PMN submission?  How may this data differ from the requirements for clinical study data required under a PMA?

Thanks in advance

Userlevel 1
Badge

Hi everyone!

I look forward to doing the AMA today. Feel free to submit any and all of your questions here before the session.

 

Best

Jon

One question I do have is relating to 'exclusion criteria' in a clinical trial. If the trial has started and the exclusion criteria is set, for example, the exclusion criteria could exclude patients who have had a fracture on both arms, would it be ok to include results from patients who have had historic fractures in only one arm and document the reasons why we have included this data?

 

Many thanks!

Userlevel 5
Badge

One question I do have is relating to 'exclusion criteria' in a clinical trial. If the trial has started and the exclusion criteria is set, for example, the exclusion criteria could exclude patients who have had a fracture on both arms, would it be ok to include results from patients who have had historic fractures in only one arm and document the reasons why we have included this data?

 

Many thanks!

@Lisa , let me know if you were unable to see the recording to get to your answer. It was a great question that sparked some good discussion, so thank you!

Reply