Just read a nice Q&A article from Murtuza Bharmal on the increased use of RWD/RWE.
The point he makes on "ensuring minimal missing data" is certainly critical to the external validity of real world data. Missing data is a big enough/bad enough issue even when dealing with data from seemingly well-designed RCTs, where it frequently ...
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. ...
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:
- End-of-life patient ...
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 ...
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 ...
