follow.it gives you an easy way to subscribe to Onbiostatistics's news feed! Click on Follow below and we deliver the updates you want via email, phone or you can read them here on the website on your own news page.
You can also unsubscribe anytime painlessly. You can even combine feeds from Onbiostatistics with other site's feeds!
Title: On Biostatistics and Clinical Trials
Is this your feed? Claim it!
In the era of highly effective therapies for may diseases, clinical researchers are increasingly encountering a "good" problem in the time to event analyses: the Kaplan-Meier survival curves are flattening out well above the 50% mark. While this represents a triumph for patient outcomes, it creates a headache for statistical reporting. When the event rate is low (below 50%), ...
When trials don’t use a traditional control — What the FDA guidance says
In the usual drug-development pathway, regulators expect a trial where patients are randomly assigned either to receive the investigational drug or a comparator (placebo or active treatment). This randomized-controlled-trial (RCT) design is the “gold standar...
FDA created a new voucher program called "Commissioner's National Priority Voucher (CNPV) Pilot Program" to href="https://www.fda.gov/industry/commissioners-national-priority-voucher-cnpv-pilot-program" target="_blank" rel="noopener...
N-of-1 clinical trial is often mentioned as one of the approaches to address the challenging issues in orphan drug development. at one point, FDA rolled out more guidance on 'N of 1' gene therapies including the guidance on "Individualized Antisense Oligonucleotide Drug Products fo...
In a previous post, I discussed steroid tapering design clinical trials. In these trials, the primary efficacy endpoint is the reduction in steroid dose. Eff...
