Training for Non Statisticians
Statistical Thinking for Non-Statisticians in Drug Regulation
Face-to-face course to be presented by Richard Kay (PhD)
October 24th to 26th 2023
Royal College of Anaesthetists, London
Based on the 3rd edition of his highly regarded book ‘Statistical Thinking for Non-Statisticians in Drug Regulation’, Richard Kay presents this 3-day course on a face-to-face basis in London. The course is aimed at Pharmaceutical Physicians and those working as MSLs and Medical Writers but is also suitable for other non-statisticians working in the pharmaceutical industry. Dr Kay has been running courses of this kind for more than 30 years and has consistently received excellent feedback for the clarity and relevance of his teaching of Statistics. In 2019 Richard was awarded the President’s Medal by the Faculty of Pharmaceutical Medicine for his outstanding contribution to pharmaceutical medicine largely based on his teaching of the subject of Statistics.
To book a place on the course go to https://docs.google.com/forms/d/e/1FAIpQLSe6zjviQJ1Px0SbOtpvxCJnoGykqLTylbwywx67_eLszjrk-w/viewform
Course Outcomes:
On completion of the course, attendees will;
Course Venue:
Royal College of Anaesthetists, Churchill House, 35 Red Lion Square, London WC1R 4SG
Face-to-face course to be presented by Richard Kay (PhD)
October 24th to 26th 2023
Royal College of Anaesthetists, London
Based on the 3rd edition of his highly regarded book ‘Statistical Thinking for Non-Statisticians in Drug Regulation’, Richard Kay presents this 3-day course on a face-to-face basis in London. The course is aimed at Pharmaceutical Physicians and those working as MSLs and Medical Writers but is also suitable for other non-statisticians working in the pharmaceutical industry. Dr Kay has been running courses of this kind for more than 30 years and has consistently received excellent feedback for the clarity and relevance of his teaching of Statistics. In 2019 Richard was awarded the President’s Medal by the Faculty of Pharmaceutical Medicine for his outstanding contribution to pharmaceutical medicine largely based on his teaching of the subject of Statistics.
To book a place on the course go to https://docs.google.com/forms/d/e/1FAIpQLSe6zjviQJ1Px0SbOtpvxCJnoGykqLTylbwywx67_eLszjrk-w/viewform
Course Outcomes:
On completion of the course, attendees will;
- Have acquired an understanding of the statistical principles that underpin a statistician’s approach to clinical drug development.
- Be aware of statistical issues that could arise during the various stages of a clinical study and the impact they could have on the conclusions.
- Be able to critically review study reports and publications in terms of the statistical methodology used.
- Be able to discuss and interpret results presented in study reports and publications which are based on statistical evaluation and assess the validity of the conclusions.
Course Venue:
Royal College of Anaesthetists, Churchill House, 35 Red Lion Square, London WC1R 4SG
Dates and Timings:
24th October: Registration at 9.00am. Course lectures and discussions, 9.30 am to 5.00pm
25th October: Course lectures and discussions, 9.00am to 5.00pm
26th October: Course lectures and discussions, 9.00am to 4.30pm
Course Topics:
1. Basic Issues in Statistical Design and Analysis
Endpoint types, sampling variation, p-values, confidence intervals, statistical testing, odds ratios, risk ratios and associated measures, power, and sample size
2. Multiplicity
Inflation of type I error, splitting the alpha, hierarchical testing, more complex settings, interim analysis, subgroup evaluation
3. The Analysis of Time-to-Event Endpoints
Censoring, Kaplan-Meier curves, medians, hazard rate and hazard ratios, logrank test, restricted mean survival time
4. Statistical Modelling
Simple linear regression, multiple regression, prediction, analysis of covariance, logistic regression, negative binomial regression, Cox regression. mixed models for repeated measures
5. Intention-to-Treat, Missing Data and Estimands
The principle of intention-to-treat, analysis sets, avoidance of missing data, single and multiple imputation, modelling to account for missing data, the estimand framework, intercurrent events, estimand strategies.
6. Equivalence and Non-Inferiority
Confidence intervals for evaluation, setting the margin, p-values for equivalence and non-inferiority, switching between non-inferiority and superiority, biosimilars.
7. Observational Studies
Logistic modelling for propensity scoring, propensity score matching and weighting, indirect treatment comparisons, matching‑adjusted indirect comparisons (MAIC)
8. Adaptive Designs
Conventional paradigm, types of adaptations, control of type I error, operational bias
9. Meta- Analysis and Network Meta-Analysis (NMA)
Pairwise meta-analysis, fixed and random effects, assessing heterogeneity, networks of comparisons, effect modifiers, critique of NMA.
Course Fees:
The course fee is £2450 (£2940 inc. VAT at 20%). This fee includes refreshments, lunches, and full course lecture notes. Also included in the fee is one copy of the eBook ‘Statistical Thinking for Non-Statisticians in Drug Regulation (3rd edition)’
Course Format:
Learning strategies will include presentations by Dr Kay, case studies, group discussions and numerous workshop exercises to illustrate the practical application of statistical methodology.
CPD Accreditation
Application has been made for the course to have CPD accreditation.
Feedback
Feedback from similar public courses run by Dr Kay:
• A difficult subject dissected into nicely digestible & retainable chunks
• The course is excellent and I’d recommend it to those on PMST but also a wider industry group
• Best course I have ever attended
• Superb and highly relevant
• I have thoroughly enjoyed the course. It is by far one of the best courses and relevant to my day-to-day practice
• Well organised, well ordered (sequence of topics), workshops were most useful
Bookings
To book a place on the course go to https://docs.google.com/forms/d/e/1FAIpQLSe6zjviQJ1Px0SbOtpvxCJnoGykqLTylbwywx67_eLszjrk-w/viewform
24th October: Registration at 9.00am. Course lectures and discussions, 9.30 am to 5.00pm
25th October: Course lectures and discussions, 9.00am to 5.00pm
26th October: Course lectures and discussions, 9.00am to 4.30pm
Course Topics:
1. Basic Issues in Statistical Design and Analysis
Endpoint types, sampling variation, p-values, confidence intervals, statistical testing, odds ratios, risk ratios and associated measures, power, and sample size
2. Multiplicity
Inflation of type I error, splitting the alpha, hierarchical testing, more complex settings, interim analysis, subgroup evaluation
3. The Analysis of Time-to-Event Endpoints
Censoring, Kaplan-Meier curves, medians, hazard rate and hazard ratios, logrank test, restricted mean survival time
4. Statistical Modelling
Simple linear regression, multiple regression, prediction, analysis of covariance, logistic regression, negative binomial regression, Cox regression. mixed models for repeated measures
5. Intention-to-Treat, Missing Data and Estimands
The principle of intention-to-treat, analysis sets, avoidance of missing data, single and multiple imputation, modelling to account for missing data, the estimand framework, intercurrent events, estimand strategies.
6. Equivalence and Non-Inferiority
Confidence intervals for evaluation, setting the margin, p-values for equivalence and non-inferiority, switching between non-inferiority and superiority, biosimilars.
7. Observational Studies
Logistic modelling for propensity scoring, propensity score matching and weighting, indirect treatment comparisons, matching‑adjusted indirect comparisons (MAIC)
8. Adaptive Designs
Conventional paradigm, types of adaptations, control of type I error, operational bias
9. Meta- Analysis and Network Meta-Analysis (NMA)
Pairwise meta-analysis, fixed and random effects, assessing heterogeneity, networks of comparisons, effect modifiers, critique of NMA.
Course Fees:
The course fee is £2450 (£2940 inc. VAT at 20%). This fee includes refreshments, lunches, and full course lecture notes. Also included in the fee is one copy of the eBook ‘Statistical Thinking for Non-Statisticians in Drug Regulation (3rd edition)’
Course Format:
Learning strategies will include presentations by Dr Kay, case studies, group discussions and numerous workshop exercises to illustrate the practical application of statistical methodology.
CPD Accreditation
Application has been made for the course to have CPD accreditation.
Feedback
Feedback from similar public courses run by Dr Kay:
• A difficult subject dissected into nicely digestible & retainable chunks
• The course is excellent and I’d recommend it to those on PMST but also a wider industry group
• Best course I have ever attended
• Superb and highly relevant
• I have thoroughly enjoyed the course. It is by far one of the best courses and relevant to my day-to-day practice
• Well organised, well ordered (sequence of topics), workshops were most useful
Bookings
To book a place on the course go to https://docs.google.com/forms/d/e/1FAIpQLSe6zjviQJ1Px0SbOtpvxCJnoGykqLTylbwywx67_eLszjrk-w/viewform
In Company Courses
Courses for Physicians, MSLs, Medical Writers and Regulatory personnel can be organised in a variety of formats, including face-to-face from one-day to 3 days as well as virtual. Topics are chosen in line with the needs of the company/audience and workshop-exercises are built around publications specific to the intended participants.
Comment from an In-company course in 2020:
I think the way Richard has structured this course is excellent. Starting from some basic principles and building on them throughout the week. The small exercises during or after lectures really help to solidify some concepts and provide some really good learning opportunities. Although still no pro, I feel much more confident about statistics after this week (In-company course, 2020)
Comment from a 2022 running of the course at Idorsia (four, 3-hour sessions; virtual):
A very big thank you for our course on “statistical thinking for non-statisticians in scientific communication”.
We all found the course extremely helpful, and the feedback both verbal and by email has been very positive. We really appreciated the amount of preparation you had done to use the resource material provided, and to tailor the course to Idorsia-relevant examples.
It was very clear that you are not just an expert in the topic, but also an expert in making the bewildering world of statistics understandable, and even enjoyable! We really appreciated the additional information you prepared to address topics that were asked about but not officially part of the course content. You also participated to our collaboration document that captured spontaneous questions from participants during the course, and even offered to continue to monitor this document for short while after the course ended – what great service! A quote from one participant sums it up nicely, “I have had so many courses on statistics, but only now with Richard does it actually make sense”.
Here are some additional comments from in-house participants in recent times:
-Excellent presenter – clear, thorough …
-Found the course enlightening and worthwhile. It will have an effect on how I perform my duties within my current position
-Very much enjoyed the course – very clear presentations – extremely helpful. I feel much better equipped to interpret the stats in clinical studies. Thanks!
-Richard was excellent. Patient and really easy to understand. Answered questions well and ensured his answer was logical & understood
-Excellent. I’m surprised that stats can be explained. Thought it is only formulas/mathematics. I enjoyed it!
Contact Richard Kay (richard.kay@rkstatistics.com) if you are interested in this course for your company.
Courses for Physicians, MSLs, Medical Writers and Regulatory personnel can be organised in a variety of formats, including face-to-face from one-day to 3 days as well as virtual. Topics are chosen in line with the needs of the company/audience and workshop-exercises are built around publications specific to the intended participants.
Comment from an In-company course in 2020:
I think the way Richard has structured this course is excellent. Starting from some basic principles and building on them throughout the week. The small exercises during or after lectures really help to solidify some concepts and provide some really good learning opportunities. Although still no pro, I feel much more confident about statistics after this week (In-company course, 2020)
Comment from a 2022 running of the course at Idorsia (four, 3-hour sessions; virtual):
A very big thank you for our course on “statistical thinking for non-statisticians in scientific communication”.
We all found the course extremely helpful, and the feedback both verbal and by email has been very positive. We really appreciated the amount of preparation you had done to use the resource material provided, and to tailor the course to Idorsia-relevant examples.
It was very clear that you are not just an expert in the topic, but also an expert in making the bewildering world of statistics understandable, and even enjoyable! We really appreciated the additional information you prepared to address topics that were asked about but not officially part of the course content. You also participated to our collaboration document that captured spontaneous questions from participants during the course, and even offered to continue to monitor this document for short while after the course ended – what great service! A quote from one participant sums it up nicely, “I have had so many courses on statistics, but only now with Richard does it actually make sense”.
Here are some additional comments from in-house participants in recent times:
-Excellent presenter – clear, thorough …
-Found the course enlightening and worthwhile. It will have an effect on how I perform my duties within my current position
-Very much enjoyed the course – very clear presentations – extremely helpful. I feel much better equipped to interpret the stats in clinical studies. Thanks!
-Richard was excellent. Patient and really easy to understand. Answered questions well and ensured his answer was logical & understood
-Excellent. I’m surprised that stats can be explained. Thought it is only formulas/mathematics. I enjoyed it!
Contact Richard Kay (richard.kay@rkstatistics.com) if you are interested in this course for your company.
“Statistical Thinking for Non-Statisticians in Drug Regulation” 3rd Edition 'Wiley'
Wiley. Aimed at non-statisticians working in the pharmaceutical industry this text provides a comprehensive and accessible guide to statistical methodology used in clinical trials in drug regulation. To purchase a copy, go to https://www.wiley.com/en-ie/Statistical+Thinking+for+Non+Statisticians+in+Drug+Regulation%2C+3rd+Edition-p-9781119867388 On check-out type the code KAY20 to receive a 20% discount. |
“Fast Facts. Medical Statistics” Karger.
Aimed at all non-statisticians in the industry who need a better understanding of the statistical terms and methods used in the planning of studies and the analysis of clinical trial data with a focus on oncology. Individuals and non-commercial organizations can now access the books free of charge via Karger’s platform with a login https://www.karger.com/fastfacts#freeaccesshttps://www.karger.com/Book/Home/279408 |