News & Views

13th Dec 2019 FDA finalise Guideline on Adaptive Designs

The FDA have finalised their guideline on 'Adaptive Designs for Drugs and Biologics'. Lots of sensible practical recommendations! https://www.fda.gov/media/78495/download

7th Jun 2019 FDA Guideline on Adaptive Designs - updated draft

An updated draft of the FDA Guideline 'Adaptive Designs for Clinical Trials of Drugs and Biologics' was issued in September 2018. This is a good document with several relevant Case Studies in an...

4th Jun 2019 CHMP Guideline on Subgroups finalised

The CHMP Guideline on the investigation of subgroups in confirmatory clinical trials was published in draft form in September 2013. It has taken quite some time but we now have a final version -...

24th Aug 2018 RK Statistics has moved

The new Trading Address for RK Statistics Ltd is Brook House, Mesne Lane, BAKEWELL, DE45 1AL, UK. The company landline number has also changed to +44 (0)1629 814807

14th Oct 2017 Threshold-Crossing, a new way of thinking for single-arm studies

The regulatory and scientific community has recently published on a new way of thinking about making comparisons based on single-arm studies with a pre-established threshold for demonstrating...