AIMS SIG - Open-Source Lunch Bites
Our monthly webinar series allows attendees to gain practical knowledge and skills in open-source coding and tools, with a focus on applications in the pharmaceutical industry.
Session presentations can be found below. They are listed by date and session title, with slide decks available to download beneath.
Please note: these are only accessible for PSI Members, and you will need to be signed in to access them.
Keynote
Alex Bellos - Communicating the magic of maths
The Fearless Statistician:
Psychological Safety in Drug
Development
The Fearless Statistician - Dirk Klingbiel Clelia Cahuzac and Anna Wiksten
AI/ML SIG: updates and
applications
1. Intro - Sam Hadlington
2. Predicting with uncertainty - Chris Harbron
3. AI Generated Synthetic Control Arms to optimize Clinical Trials - Paola Berchialla
4. Explainable AI for Causal Inference and Heterogeneous Treatment Effect Estimation via AI ML - Karl Koechert and Eliana Garcia-Cossio
Borrowing Strength or Buying Trouble? Using External Data in Regulatory Context
1. Thinking beyond the norm how to fairly evaluate Bayesian Dynamic Borrowing Designs - Gaelle Saint-Hilary
2. Another form of hybrid trial designs with external information - Juan Jose Abellan
3. Echo of the Past The Prespecification Challenge in Hybrid RCTs - Franz Konig
4. Challenges when using external control data for regulatory decision making - Florian Klinglmueller
PFDD SIG: How to use PROs in
early development
PFDD SIG - How to use PROs in early development - Devin Peipert Alexandra Lauer Evgeniya Reshetnyak and Rachael Lawrance
Navigating the Move to Open
Source - Effective Strategies for
Adoption and Working with
Different Software
1. Intro - Martin Brown
2. R Adoption & Change Management - Martin Brown
3. Mastering the Art of Adopting R and Python - Mark Bynens
4. R you all right, SAS - Lyn Taylor and Christina Fillmore
Grow Your Own Way
Grow your own way -Isabelle Smith and Lucy Rowell
SEE-ing the Future: Empowering
Health Decisions through
Structured Expert Elicitation
1. Intro - Min Hua Jen
2. Structured Expert Elicitation in Drug Development - Roel Straetemans
3. Bespoke structured expert elicitation protocol for long-term survival outcomes - Kate Ren
4. What Do We Want to SEE - Hugo Pedder
5. survextrap - Flexible and transparent Bayesian survival modelling using combinations of data and judgements - Christopher Jackson
Career Young Statistician
1. CYS-Prognostic score adjustment for marginal effect estimation with GLMs - Emilie Hojbjerre-Frandsen
2. CYS-Is there really any benefit to stratified randomisation in practice - Pavankumar Bhagat
3. CYS-Frailty prediction using digital sensor data, an interpretable machine learning approach - Gaizka Pérez
4. CYS-Reconstructing Individual Patient Level Survival Data from Aggregate Survival Data using a Simulation Approach - Rebecca Boucher
5. CYS-Development and Evaluation of a Predictive Ensemble Learning Framework for Breast Cancer Radiotoxicities at 2 Years - Samana Bano
Causal Inference in clinical trails
1. DoubleMLDeep Estimation of Causal Effects with Multimodal Data - Martin Spindler
2. Decoding optimal methods in treatment switching - Orlando Doehring
3. Targeted Maximum Likelihood Estimation for Restricted Mean Survival Time in time-to-event data with low event rates - Michael Seath
4. Vaccine Efficacy waning estimation and extrapolation using causal inference - Jyoti Soni and Andrea Callegaro
Bayesian/Master Protocols
1. Bayesian life-course modelling of Alzheimer’s Disease progression - David Lunn
2. A basket trial design based on constrained hierarchical Bayesian model for latent subgroups - Atsuki Hashimoto
3. Optimizing Paediatric Outcomes Advanced Bayesian Modelling of Days Without Mechanical Ventilation in Respiratory Trials -Danila Azzolina
Dose Optimisation
1. Designing a seamless P1 P2a open enrolment CRM dose escalation study - Elias Laurin Meyer
2. Evaluating Early-Stage Oncology Clinical Trials in the Era of Project Optimus - A scoping review - Anais Andrillon
3. The Optimus Journey - FDA-Approved Examples of Dose Optimization in FIH Oncology Trials - Benoit Sansas
Career Young Statistician 2
1. CYS2 -Applying prognostic scoring adjustments to enhance clinical trial efficiency in neurodegenerative diseases - Harry Parr
2. CYS2-New numerical methods for calculating the effective sample size after population adjustment - Landan Zhang
3. CYS2-Context-dependent response-adaptive randomization for continuous endpoints and applications - Luca Rondano
4. CYS2-When to schedule the interim analysis in the presence of missing data - Neza Dvorsak
Keynote
Bridging the Divide - How Academia Industry collaborations have the power to transform clinical development - Jennifer Visser Rogers
Inclusive Work Cultures: Where Everyone Thrives
Inclusive Work Cultures - Where Everyone Thrives - Addison Barnett Emma Crawford Ursula Becker Nicola Hewson and Karen Smith
Statistical Software Engineering
1. The Mythical Man Month - Wilmar Igl
2. Continuous Integration practices for statistical software development - Pravin Madhavan
3. Scaling Statistical Innovation and Open Source Collaborations - Isaac Gravestock
4. Analysis Specification to Execution in R Shiny - Brian Lang
Evidence Synthesis for HTA.
Squaring the Circle: Bridging
Innovation with Application
Evidence Synthesis for HTA - Lytske Bakker Nicky Welton Min-Hua Jen Gregory Chen Anders Gorst Rasmussen and Keith Abrams
Missing Data and Estimands
1. Continuous Composite Endpoints - How Bad is Too Bad - James Bell
2. Estimation for treatment policy strategies with missing data - Introducing retrieved dropout reference-base centred multiple imputation - Suzi Cro
3. How many multiple imputations do I need for an important analysis - Tim Morris
Navigating Difficult Conversations
in the Workplace
Navigating Difficult Conversations in the Workplace - Emma May Sam Ruddell and Katie Thorn
Quantitative Decision Making -
How Frameworks Could Help You
1. Going beyond Probability of Success for Early Development studies - Trevor Smart
2. Quantitative Decision Making - How Frameworks Could Help You - Gustaf Rydevik
3. Decision-Making Criteria and Methods for Initiating Late-Stage Clinical Trials from a MultiStakeholder Perspective - A Scoping Review - Julien Tanniou
Treatment Effect Heterogeneity
SIG
1. Bayesian shrinkage estimation for subgroup analysis in clinical trials - Examining the critical aspects - Björn Bornkamp
2. A simulation study to compare Group Sequential Designs for subpopulation testing and enrichment procedure - Marie-Karelle Riviere
3. Improving Outlier Detection in Subgroup Analysis using Bayesian Predictive Cross-validation Models - Wilmar Igl
Regulatory Hot topics session
1. Perspectives on Bayesian statistics in regulatory decision making - Peter van de Ven
2. Perspectives on Bayesian Statistics in Regulatory Decision Making - Nicky Best
3. Development of the ICH E20 guideline on adaptive designs in clinical trials - current status and future work - Frank Bretz Khadija Rantell and Armin Koch
TED
1. A multi-arm multi-stage design for trials with no control arm and all pairwise testing - Peter Greenstreet
3. Sample size matters! – demonstrating sample size calculations across software - Agnieszka Tomczyk and Lyn Taylor
4. Frequentists United - A Safe Space for Embracing Bayes - Patrik Atkinson
5. Biostatistical Challenges in Medical Device Clinical Trials - Michael Mader
Successful Use of Bayesian
Dynamic Borrowing Methods in
Regulatory Settings
Successful Use of Bayesian Dynamic Borrowing Methods in Regulatory Settings - Nicky Best
AI / Machine Learning
1. Predicting the probability of clinical trials success from AI-based approaches using multimodal data - Nils Ternes
2. Enhancing Treatment Effect Estimation in Clinical Trials using Machine Learning - A Within-Study Prognostic Score Approach - Antigoni Elefsinioti
3. Application of causal inference to identify determinants of seizure reduction and quality of life - Teresa Greco
Rare diseases and special
populations
1. INVENTS - Going Beyond Conventional RCTs for Rare and Paediatric Diseases – Insights from Year 1 of the European Collaboration - Marcus Elze
2. Statistical Challenges in Health Technology Assessment for Rare Diseases - Samadhan Ghubade
3. Randomization-based Inference for MCP-Mod - Lukas Pin
Marginal Estimands and Estimation
with Covariate Adjustment for TTE
Endpoints
1. Intro - Sarwar Mozumder and David Wright
2. Marginal hazard ratios and covariate adjustment – A causal inference perspective - Rhian Daniel
3. Efficiency of nonparametric superiority tests based on restricted mean survival time versus the log rank test - Dominic Magirr
4. Covariate adjustment in time-to event data - single and doubly-robust methods - Sanne Roels
5. Ensuring covariate adjustment methods for TTE outcomes are fit for use - Tim Morris
Patient preference studies
1. Intro - Conny Berlin
2. Published patient preference studies can influence the choice of endpoints in clinical trials – Byron Jones
3. Assessing the Readiness of the Patient Preference Study Landscape for Meta-Analyses and Benefit Transfers - Michael Bui
4. Enhancing Generalizability in Patient Preference Studies - Addressing Sample Skewness in the associated Covariate Distribution - Divya Mohan
5. Patient Preferences in Clinical Trials - Challenges and Opportunities - Cecilia Jimenez Moreno
Future-proofing healthcare
beyond today for tomorrow’s
medicines with advancement in
benefit-risk assessments (BRA)
1. What does the CIOMS WG XII Benefit-Risk Assessment Report say - Shahrul Mt-Isa
2. Innovative trial designs and effect size estimation - Ursula Garczarek
3. Implementing innovative safety evaluation methods - Naomi Givens
4. Methodological aspects and practical application of a drug quantitative BRA - Pavel Mozgunov
Leadership TED
1. How to be wrong - Simon Cleall
2. Stepping into leadership - How will I manage - Catherine Dixon
3. Enhancing Cross-functional Partnership in Early Oncology Clinical Development - A Practical Guide for Biostatisticians - Laura Barker
4. Trust actually - Building teams that love to work together - Zainab Walsh
5. Building High-Performing Teams - Leadership Strategies for Navigating Change and Driving Growth - Aga Rasinska
6. Trust - The Backbone of Leadership - Alun Bedding
Use of external data to improve
clinical trials
1. Steps in using healthcare systems data as outcome data in clinical trials - Sharon Love
2. Why Accurate Time to response prediction matters - Donia Skanji
3. Survival of the Fittest - Digitising Survival Data for Enhanced Decision-Making in Clinical Trials - James Sykes and Nelson Kinnersley
Estimands: Methods, theory and
case studies
1. Estimand Sample Sizes - Thomas Drury
2. How Do Meta-Analyses Handle Treatment Switching - A Systematic Review - Rebecca Metcalfe
3. Determining the non-inferiority margin in light of the ICH E9(R1) estimand framework - Sunita Rehal
Bayesian Dynamic Borrowing
1. Unexpected results and challenges when using mixture priors for Bayesian borrowing - Darren Scott
2. Non-monotonic power in Bayesian dynamic borrowing insights and practical remedies - Gianmarco Caruso
3. Biased borrowing or borrowing bias - Leveraging Bayesian borrowing and quantitative bias analysis for robust comparative effectiveness insights - Grace Hsu
EU HTA: readying ourselves for the road to 2025 and beyond
1. EU HTA - Communicating Statistics & Uncertainty - The Case of Health Technology Assessment - Lara Wolfson
2. Help your non-statistician audience make sense of risk - Maricarmen Climente
3. Communicating statistical concepts to an HTA Audience - Nick Latimer