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A kind request for a reference to a resource on the approval from FDA #1

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Generalized opened this issue Feb 26, 2020 · 0 comments

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@Generalized
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Generalized commented Feb 26, 2020

Not an issue, actually, but rather a kind request. I found a presentation on the Research Gate:
https://www.researchgate.net/publication/239808125_frailtypack_An_R_Package_for_the_Analysis_of_Correlated_Survival_Data_with_Frailty_Models_Using_Penalized_Likelihood_Estimation_or_Parametrical_Estimation

Where it is said:

Ongoing Collaboration : the US-FDA has agreed that FRAILTYPACK can be used for primary analysis of a phase 3 trial on recurrent hospitalizations for severe heart failure

Could you, kindly, share any resource on that? A document from FDA, for example (if not a secret)? Is this collaboration still ongoing in other areas as well?

Do you have any unit tests via testthat package (or any other quality assessment) of the code? I mean - for the purpose of numerical validation. I could not find it in the code.

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