News & Views

10th Feb 2020 Statistical Significance - Problems and Solutions?

There has been much recent discussion about problems associated with the use of 'statistical significance' and the resulting dichotomy; p<0.05 supports the presence of an effect, while p>0.05...

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