Missing data
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Estimands

When it comes to assessing the impact of how well patients (and arguably centres) in a randomised clinical trial follow the protocol, the standard method for some decades has been via the identification of the ‘Per Protocol’ set. This ICH-driven subset of ITT patients essentially requires the review of blinded patient data at the end of the trial. ...

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HTA

NICE are currently undergoing what appears to be quite a wide re-evaluation of their HTA process. As part of this process, they have recently released a white paper for comment, entitled “The NICE methods of health technology evaluation: the case for change”.

I've picked out some (mostly statistical) highlights:

  1. End-of-life patient ...
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RWE

ISPOR’s Value and Outcomes Spotlight recent Sep/Oct 2020 issue contained an interesting Q&A article with Jennifer Graff (VP, Comparative-Effectiveness Research, National Pharmaceutical Council). Overall, it was interesting, high-level stuff - which raised a few Qs in my head. Some extracts from the article:

"Researchers have estimated ...

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COVID-19

Another FDA guideline on COVID-19 has just been released and, given the pressing nature of the current pandemic, comes into immediate effect: https://www.fda.gov/media/142749/download

I’ve picked out a couple of sections from the guidance, along with my thoughts on each…

“...issuance ...

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