News and Views
Welcome to my news page. Here I take the opportunity to post information on my courses or any other items of interest relating to statistics in clinical studies and the pharmaceutical industry.
12th April 2023
RK Statistics is delighted to announce: Statistical Thinking for Non-Statisticians in Drug Regulation a face-to-face course to be presented by Dr Richard Kay October 24th to 26th 2023 at the Royal College of Anaesthetists, London. Further details on this course including content, course fees and how to book are provided here
1st January, 2023
The 3rd edition of my book ‘Statistical Thinking for Non-Statisticians in Drug Regulation’ published by Wiley now available at https://www.wiley.com/en-ie/Statistical+Thinking+for+Non+Statisticians+in+Drug+Regulation%2C+3rd+Edition-p-9781119867388. Highlights include new chapter on Estimands in line with the 2019 Addendum to ICH E9, major new sections on topics including Combining Hierarchical Testing and Alpha Adjustment, Biosimilars, Restricted Mean Survival Time, Composite Endpoints and Cumulative Incidence Functions, Adjusting for Cross-Over in Oncology, Inverse Propensity Score Weighting, and Network Meta-Analysis and updated coverage of many existing topics to reflect new and revised guidance from regulatory authorities and author experience.
12th April 2023
RK Statistics is delighted to announce: Statistical Thinking for Non-Statisticians in Drug Regulation a face-to-face course to be presented by Dr Richard Kay October 24th to 26th 2023 at the Royal College of Anaesthetists, London. Further details on this course including content, course fees and how to book are provided here
1st January, 2023
The 3rd edition of my book ‘Statistical Thinking for Non-Statisticians in Drug Regulation’ published by Wiley now available at https://www.wiley.com/en-ie/Statistical+Thinking+for+Non+Statisticians+in+Drug+Regulation%2C+3rd+Edition-p-9781119867388. Highlights include new chapter on Estimands in line with the 2019 Addendum to ICH E9, major new sections on topics including Combining Hierarchical Testing and Alpha Adjustment, Biosimilars, Restricted Mean Survival Time, Composite Endpoints and Cumulative Incidence Functions, Adjusting for Cross-Over in Oncology, Inverse Propensity Score Weighting, and Network Meta-Analysis and updated coverage of many existing topics to reflect new and revised guidance from regulatory authorities and author experience.
8th May 2020
Offering WebEx training courses in Statistics
In light of the COVID-19 situation, RK Statistics is now offering WebEx based short courses to pharmaceutical companies
Read more...
Offering WebEx training courses in Statistics
In light of the COVID-19 situation, RK Statistics is now offering WebEx based short courses to pharmaceutical companies
Read more...
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
Read more...
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
Read more...
1st Feb 2020
PMST S&DM course 2020, June and April dates
Unfortunately due to slow recruitment, the June (June 1st to June 5th) running of the PMST Statistics and Data Management in Practice course has been cancelled. Recruitment for the April dates (April 20th to April 24th) however has been good and this course will go ahead. A few places remain, but you will need to book soon to be sure of a place
PMST S&DM course 2020, June and April dates
Unfortunately due to slow recruitment, the June (June 1st to June 5th) running of the PMST Statistics and Data Management in Practice course has been cancelled. Recruitment for the April dates (April 20th to April 24th) however has been good and this course will go ahead. A few places remain, but you will need to book soon to be sure of a place
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
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
20th Nov 2019
Richard Kay receives Faculty of Pharmaceutical Medicine Presidents Medal
Richard has been awarded the Presidents Medal of the Faculty of Pharmaceutical Medicine for his 'Outstanding Services to Pharmaceutical Medicine'.
Read more...
Richard Kay receives Faculty of Pharmaceutical Medicine Presidents Medal
Richard has been awarded the Presidents Medal of the Faculty of Pharmaceutical Medicine for his 'Outstanding Services to Pharmaceutical Medicine'.
Read more...
13th Aug 2019
PMST Statistics and DM in Practice - book now to secure a place for 2020
The brochure and application form for the course are now available and booking for 2020 is open. Click here
PMST Statistics and DM in Practice - book now to secure a place for 2020
The brochure and application form for the course are now available and booking for 2020 is open. Click here
8th Jul 2019
PMST S&DM course - dates finalised
The dates have now been finalised for 2020 - minor changes from what was put on the site a short while ago. The 2020 dates are April 20th to April 24th and June 1st to June 5th.If you would like to attend then please contact [email protected] to request a provisional place and application form
PMST S&DM course - dates finalised
The dates have now been finalised for 2020 - minor changes from what was put on the site a short while ago. The 2020 dates are April 20th to April 24th and June 1st to June 5th.If you would like to attend then please contact [email protected] to request a provisional place and application form
10th Jun 2019
PMST Statistics and DM in Practice in 2020
Provisional 2020 dates have been set for this 5-day course run by RK Statistics. There will again be two opportunities to attend; April 27th to May 1st and June 1st to June 5th. These course will take place at the Denham Grove Hotel, Denham. If you would like to register your interest then please contact [email protected] and your name will be added to the wait list. Once final arrangements for the course have been put in place we will be publishing a Brochure and Application Form on this webpage. Watch this space
PMST Statistics and DM in Practice in 2020
Provisional 2020 dates have been set for this 5-day course run by RK Statistics. There will again be two opportunities to attend; April 27th to May 1st and June 1st to June 5th. These course will take place at the Denham Grove Hotel, Denham. If you would like to register your interest then please contact [email protected] and your name will be added to the wait list. Once final arrangements for the course have been put in place we will be publishing a Brochure and Application Form on this webpage. Watch this space
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 area where techniques and regulatory thinking are developing all the time
https://www.fda.gov/media/78495/download
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 area where techniques and regulatory thinking are developing all the time
https://www.fda.gov/media/78495/download
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 - adopted 31st Jan 2019 and coming into effect on 1st August 2019.
https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-investigation-subgroups-confirmatory-clinical-trials_en.pdf
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 - adopted 31st Jan 2019 and coming into effect on 1st August 2019.
https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-investigation-subgroups-confirmatory-clinical-trials_en.pdf