An interesting introductory lecture on issues to consider for utilizing wearable devices in regulatory decision making. This lecture was sponsored by ePRO Consortium under Critical Path Institute. c-path.org/selection-and-…

The latest special issue of JBS is out now! It is a must see. Topics covered include adaptive designs, platform trials, dose finding trial, etc…. Which articles are of more interest to you? Let us know! We would like to hear from you! lnkd.in/gqbGUgY

#clinicaltrials COVID 19 has accelerating the process of modernizing clinical trial (e.g. home-based visits). TransCelerate has issued a white paper on this issue. transceleratebiopharmainc.com/wp-content/upl…

Construction of a survival tree for dependent censoring Journal of Biopharmaceutical Statistics T&F STEM tandfonline.com/doi/full/10.10…

#innovation #statistics #data “A year in review” from the editor in chief of the Journal of Biopharmaceutical Statistics. Very interesting insights. tandfonline.com/doi/full/10.10…

#vaccinesafety #covid19vaccine An interesting article from Philadelphia Children’s Hospital. It puts a historical perspective on vaccine safety concerns. chop.edu/news/long-term…

BOOK REVIEW: Statistics and machine learning methods for EHR data – From data extraction to data analytics CRC Press Data Science, Stats, and Math Books CRC Press Journal of Biopharmaceutical Statistics tandfonline.com/doi/full/10.10…

An interesting article comparing #Bayesian pooling with sequential integration, via simulations, for small #preclinical #trials. For the linear models used in the simulation the results were similar. However, for nonlinear models’ several caveats appear. doi.org/10.1080/105434…

An interesting overview of things to consider when selecting #wearables to be used in #clinicaltrials. One advise should be very familiar to #statisticians: “…you should know what you want to measure before selecting the wearable device.” valencell.com/blog/wearables…

Bigger and bigger circles - the expanding biopharmaceutical statistician’s toolbox Journal of Biopharmaceutical Statistics T&F STEM tandfonline.com/doi/full/10.10…

Systematic #BenefitRisk assessment is part of #PBRER/#DSUR and the #CTD and is important to regulators, payors and patients. Enclosed you will find an interesting article on Benefit-Risk assessment for diagnostic tests. doi.org/10.1080/105434…