Can you use patient registry data as a source?
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Hi there! I am wondering if you can use patient registry data to support claims in branded HCP pieces (for example, something like https://www.corevitas.com/registry/)? More specifically,
-Could you use patient registry data to support efficacy claims? (my gut tells me 'no' since the data is not peer reviewed)
-Would it help if the data is consistent with the PM in terms of pt population, dosing, etc.?
-Could you use patient registry data to support patient support program claims (e.g., satisfaction with the PSP)?
-Could you use patient registry data to support disease information (e.g., 60% of people with disease X also have comorbidity Y)?
-The above registry is American - does this matter for Canadian materials?Thank you so much for any help!
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Hi there! I am wondering if you can use patient registry data to support claims in branded HCP pieces (for example, something like https://www.corevitas.com/registry/)? More specifically,
-Could you use patient registry data to support efficacy claims? (my gut tells me 'no' since the data is not peer reviewed)
-Would it help if the data is consistent with the PM in terms of pt population, dosing, etc.?
-Could you use patient registry data to support patient support program claims (e.g., satisfaction with the PSP)?
-Could you use patient registry data to support disease information (e.g., 60% of people with disease X also have comorbidity Y)?
-The above registry is American - does this matter for Canadian materials?Thank you so much for any help!
Hi @kshulist!
- Could you use patient registry data to support efficacy claims? (my gut tells me 'no' since the data is not peer reviewed)
Your gut is correct. Evidence for efficacy should meet requirements per PAAB code section 3.1. - Would it help if the data is consistent with the PM in terms of pt population, dosing, etc.?
No, it would not change the answer to the above. - Could you use patient registry data to support patient support program claims (e.g., satisfaction with the PSP)?
With appropriate disclosure of the survey methodology and other pertinent information, patient support claims that do not pertain to efficacy, safety may be considered, e.g. how many patients were satisfied with their PSP or PSP coordinator, etc. - Could you use patient registry data to support disease information (e.g., 60% of people with disease X also have comorbidity Y)?
Depending on the methodology, PAAB may consider the data for disease information. - The above registry is American - does this matter for Canadian materials?
It can matter depending on what is being presented. For example, if geography is a factor such as in antimicrobials, it may be questioned as it would not be relevant to Canada.
- Could you use patient registry data to support efficacy claims? (my gut tells me 'no' since the data is not peer reviewed)
-
Hi @kshulist!
- Could you use patient registry data to support efficacy claims? (my gut tells me 'no' since the data is not peer reviewed)
Your gut is correct. Evidence for efficacy should meet requirements per PAAB code section 3.1. - Would it help if the data is consistent with the PM in terms of pt population, dosing, etc.?
No, it would not change the answer to the above. - Could you use patient registry data to support patient support program claims (e.g., satisfaction with the PSP)?
With appropriate disclosure of the survey methodology and other pertinent information, patient support claims that do not pertain to efficacy, safety may be considered, e.g. how many patients were satisfied with their PSP or PSP coordinator, etc. - Could you use patient registry data to support disease information (e.g., 60% of people with disease X also have comorbidity Y)?
Depending on the methodology, PAAB may consider the data for disease information. - The above registry is American - does this matter for Canadian materials?
It can matter depending on what is being presented. For example, if geography is a factor such as in antimicrobials, it may be questioned as it would not be relevant to Canada.
@jennifer-carroll Thanks so much!!
- Could you use patient registry data to support efficacy claims? (my gut tells me 'no' since the data is not peer reviewed)
