19.04.2023: Adaptive Designs and Multiple Testing Procedures 3-day Workshop
Agenda
No recording available
No slides available ::: {.cell}
:::
12.04.2023: Quantification of risk: ask the right questions or time to apply the estimand framework to safety!
Agenda
Recording
Recording 2
| Rima Izem (starts at 02:00 in 1st part) |
Novartis |
Welcome, scene setting and “Let us put the scientific objective first!” |
link |
| Kaspar Rufibach (starts at 32:00 in 1st part) |
Roche |
Stop the abuse: A plea for a more principled approach to the analysis of time-to-event endpoints with varying follow-up times and/or competing risks, with a focus on analysis of AEs. |
link |
| Andrew Thomson (discussant, beginning of 2nd part) |
EMA |
Comments (no slides) |
No presentation available (may be added later for recent events, after having received speaker approval) |
| Shanti Gomatam (discussant, starts at 15:00 in 2nd part) |
FDA |
Quantification of risk: ask the right questions or time to apply the estimand framework to safety |
link |
15.03.2023: Joint BES/BBS webinar: Real-World Data Quality
Agenda
Recording
| Massoud Toussi (starts at 5:38) |
IQVIA |
What is data quality, and how data types differ in terms of data quality |
link |
| Nicole Mahoney (25:35) |
Novartis |
RWD for regulatory decisions |
link |
| Clair Blacketer (39:48) |
Janssen |
EHDEN: Data Quality Dashboard |
link |
| Daniel Morales (59:40) |
EMA |
EU Data quality framework |
link |
| Dalia Dawoud (1:18:43) |
NICE |
COPD case study - The Use of the OMOP Common Data Model in Health Technology Assessment |
link |
| Spencer James (1:41:34) |
Roche/Genentech |
Data quality in Flatiron |
link |
| Gracy Crane (NB this talk in the panel discussion section was not recorded, but the slides are attached) |
Roche |
Transcelerate - How to bridge from framework to fitness for purpose demonstration? |
link |
15.12.2022: Joint EFSPI & BBS virtual event - Addressing intercurrent events: Treatment policy and hypothetical strategies (day 2)
Agenda
Recording
Recording 2
| Frank Bretz & Mouna Akacha |
Novartis |
The hypothetical strategy: why, how, when? |
link |
| Jinglin Zhong |
Otsuka |
A case study of hypothetical strategies in acute pain |
link |
| Jonathan Bartlett |
LSHTM |
Hypothetical estimands – a unification of causal inference and missing data methods |
link |
| Florian Lasch |
EMA |
g-estimation for the hypothetical strategy with an application to Alzheimer’s Disease and COVID-19-related intercurrent events |
link |
| Ian White |
University College London |
Estimation with multiple intercurrent events and mixed estimand strategies |
link |
| Kelly van Lancker |
Ghent University |
Discussion |
link |
| Lei Nie |
FDA |
Discussion |
No presentation available (may be added later for recent events, after having received speaker approval) |
08.12.2022: Joint EFSPI & BBS virtual event - Addressing intercurrent events: Treatment policy and hypothetical strategies (day 1)
Agenda
Recording
Recording 2
| David Wright |
AstraZeneca |
Reflections on the estimands addendum with a focus on the treatment policy strategy |
link |
| Thomas Drury |
GSK |
Implementation of the treatment policy strategy for continuous longitudinal endpoints: A Comparison of Estimation Methods |
link |
| Marcel Wolbers & Alessandro Noci |
Roche |
Treatment policy estimation based on standard and reference-based conditional mean imputation |
link |
| Daniel Sabanés Bové |
Roche |
Other statistical software for continuous longitudinal endpoints: mmrm R package |
link |
| James Roger |
LSHTM |
Other statistical software for continuous longitudinal endpoints: SAS macros for multiple imputation |
link |
| Suzie Cro |
Imperial College London |
Discussion on treatment policy strategy |
link |
30.11.2022: Next Generation Networking Seminar
Agenda
Recording
| Uli Burger |
Roche |
Welcome and Introduction to Event Series |
No presentation available (may be added later for recent events, after having received speaker approval) |
| Youyou Hu & Antonella Mazzei |
Roche & BMS |
Getting started |
No presentation available (may be added later for recent events, after having received speaker approval) |
| Julie Jones |
Novartis |
Communicating statistics to a lay audience |
No presentation available (may be added later for recent events, after having received speaker approval) |
| Frank Bretz & Uli Burger |
Novartis & Roche |
Evolution of Biometrics within and across Pharma: Current trends and future insights |
No presentation available (may be added later for recent events, after having received speaker approval) |
| Gabriele Bieska, Joerg Maurer, Valda Murphy, Simon Wandel, Marcel Wolbers |
Roche, Roche, Novartis, Novartis, Roche |
Not All Roads May Lead to Rome – Panelists’ Pitch on their career paths in industry |
No presentation available (may be added later for recent events, after having received speaker approval) |
15.07.2022: On market approval and market access: Breaking the linear thinking or how to innovate in a crowded space?
Agenda
Recording
| Frank Bretz |
Novartis |
Welcome |
link |
| Anja Schiel (starts at 00:04:00) |
NOMA & EMA |
Start thinking HTA early |
link |
| Nigel Yateman (01:01:15) |
Novartis |
Challenges in developing next generation CAR-T |
link |
| Iain Bennett (01:22:30) |
Roche |
No comparators no problem? |
link |
| Karen Facey (01:42:50) |
University of Edinburgh and self-employed |
Comments to introduce panel discussion |
link |
| Speakers + Gorana Capkun, Lilla di Scala, Andrew Thomson (01:58:15) |
|
Panel discussion |
No presentation available (may be added later for recent events, after having received speaker approval) |
23.06.2022: BBS / EFSPI Seminar Registry studies and HTA
Agenda
Recording
| Fred Sorenson |
Xcenda, Switzerland |
Welcome |
No presentation available (may be added later for recent events, after having received speaker approval) |
| Eric Faulkner and Omar Dabbous |
Novartis Gene Therapies, USA |
An open dialog on the issues faced and lessons learned with respect to Novartis Gene Therapies’ Spinal Muscular Atrophy (SMA) registries |
No presentation available (may be added later for recent events, after having received speaker approval) |
| Entela Xoxi |
Università Cattolica del Sacro Cuore, Italy |
AIFA registries: past and current & upcoming challenges |
link |
| Jinma Ren and Friedhelm Leverkus |
Pfizer, USA and Pfizer, Germany |
Issues in the design and analysis of registry-based studies for regulatory and HTA purposes |
link |
| Mei Yang |
Happy Life Technology, China & USA |
Registries in China: Guidelines, trends and new technologies |
link |
| Rossella Di Bidino |
Fondazione Policlinico Universitario Agostino Gemelli, Italy |
Hospital Perspective on using Registry Data for HTA |
link |
| Kirk Geale |
Quantify Research, Sweden |
Case studies using Registry Data for HTA in Scandinavia |
link |
| Kat Belendiuk |
Genentech, USA |
FlywheelMS Case Study - A complete web-based digital registry of 5,000 patients with Multiple Sclerosis in the USA |
No presentation available (may be added later for recent events, after having received speaker approval) |
29.03.2022: Graphical approaches to multiple test problems
Agenda
Recording
Recording 2
| Marc Vandemeulebroecke |
Novartis, Basel |
Welcome |
No presentation available (may be added later for recent events, after having received speaker approval) |
| Ekkehard Glimm, Frank Bretz & Dong Xi |
Novartis & Gilead |
Graphical approaches to multiple test problems |
link |
21.02.2022: Machine Learning in clinical drug development
Agenda
Recording
| Markus Lange, Lorenz Uhlmann |
Novartis, Basel |
Machine Learning in clinical drug development |
link |
| Markus Lange, Lorenz Uhlmann |
Novartis, Basel |
Questions from the chat, with answers |
link |
| Markus Lange, Lorenz Uhlmann |
Novartis, Basel |
R exercises |
link |
| Markus Lange, Lorenz Uhlmann |
Novartis, Basel |
Dataset used for exercises |
link |
27.07.2021: Joint BBS/BES Webinar COVID-19 pandemic and how we deal with data
Agenda
Recording
| Hans Ulrich Burger |
Roche, Basel |
Welcome |
No presentation available (may be added later for recent events, after having received speaker approval) |
| Tim Friede |
University Medical Center Göttingen |
Data and Statistics as a basis for decision making: A discussion of the Corona pandemic |
link |
| Thorsten Lehr |
Saarland University |
Forecasting: What do we learn? |
link |
| Thierry Van Effelterre |
J&J |
Vaccination trials: What do we know about long-term efficacy measures and other questions |
link |
| Fei Chen |
Janssen |
Statistical Considerations Underlying a COVID-19 Vaccine phase 3 design |
link |
28.06.2021: Joint EFSPI/BBS Meeting Precision & Innovative Medicine and Health Technology Assessment
Agenda
Recording
| Fred Sorensen |
Xcenda |
Welcome |
link |
| Dan O’Connor |
MHRA, UK |
The UK’s Innovative Licensing and Access Pathway (ILAP) for medicines – A joint MHRA, NICE & SMC initiative |
link |
| Karen Facey |
University of Edinburgh |
IMPACT HTA - Recommendations for Developing Rare Disease Treatments |
link |
| Paul Cislo, Jinma Ren and Joseph C. Cappelleri |
Pfizer |
Adjusting Global Survival to Make Results More Relevant and Generalizable to Local Markets |
link |
| Marc Buyse |
IDDI and University of Hasselt, Belgium |
Net benefit and correlation between benefit and harms |
link |
| Mark Belger and Marie-Ange Paget |
Eli Lilly UK & France |
Closing the efficacy to effectiveness gap: Generalizing from RCTs to real world populations |
link |
| Kirsten Herrmann |
Exact Sciences, Germany |
Assessments and reimbursement of gene expression signature tests in Europe |
link |
| Janneke Boersma |
Roche, Netherlands |
Bridging the gap between Regulatory & HTA approval for Precision Medicine therapies: a case study from the Netherlands |
link |
16.06.2021: BBS Webinar Impact of the COVID-19 Pandemic on Clinical Trials
Agenda
Recording
| Anja Schiel |
Chair Scientific Advice Working Party, EMA |
Overview on early experience of the impact of Covid-19 pandemic on clinical trials |
link |
| Paul Delmar |
Roche, Basel |
COVID-19 pandemics : Impact on Clinical Trials in a chronic progressing disease |
link |
| Eva Hua |
Novartis, Basel |
Hypothetical strategy for a case study affected by COVID-19 pandemic |
link |
| Kelly Van Lancker |
Ghent University |
The hypothetical estimand and its potential estimators in clinical trials impacted by COVID-19 |
link |
22.03.2021: BBS Webinar Statistical challenges in the clinical development of CAR T-cell therapies
Agenda
Recording
| Roland Marion-Gallois |
BMS, Switzerland |
Welcome and Introduction |
link |
| Caroline Aarber Bath |
CHUV, Switzerland |
Introduction to Cell Therapies: A Clinical Perspective |
link |
| Elina Asikanius |
FIMEA, Finland |
Perspective from EMA |
link |
| Zhenzhen Xu |
FDA, USA |
Perspective from FDA |
link |
| Khadija Rantell |
MHRA, UK |
Phase 2 / Phase 3, Treatment effect or therapeutic strategy effect? |
link |
| Alessandro Previtali |
BMS, Switzerland |
Phase 2 / Phase 3, Estimands in the context of cell therapy development |
link |
| Nigel Yateman |
Novartis, Switzerland |
Challenges for new CAR-T therapies |
link |
| Oriana Ciani |
Università Bocconi, Italy |
Introduction on Post-Approval challenges, reimbursement and HTA assessments |
link |
| Andrea Smith |
G-BA, Germany |
HTA-Perspective on the assessment of CAR-T-Cell Therapies |
link |
| Marcelo Pasquini and Zhenuan Hu |
CIBMTR, USA |
CAR-T cell therapy registries |
link |
08.03.2021: Graphics for decision-making in biomedical research and drug development
Agenda
Recording
| Dominik Heinzmann |
Roche, Basel |
Welcome |
No presentation available (may be added later for recent events, after having received speaker approval) |
| Hannah Diehl and Tamara Broderick / Andy Stein and Niladri Roy Chowdhury |
MIT and Novartis |
The “See”-Value App: Visual Decision Making for Drug Development |
link |
| Neil McQuarrie |
Flatiron |
Better understanding and reacting on impact of COVID-19 on RWD collection by combining statistics with visualization |
link |
| Tadeusz Lewandowski |
Roche, Basel |
Interactive clinical study visualisation in enabling the faster decision making |
link |
| Markus Lange |
Novartis, Basel |
Unraveling a single number – using graphics to explain Probability of Success |
link |
| Anne-Marie Meyer |
Roche, Basel |
Population Level Analytics for pandemic response: Predicting vaccine uptake and vaccine hesitancy |
link |
| Giusi Moffa |
University of Basel |
Closure |
No presentation available (may be added later for recent events, after having received speaker approval) |
03.11.2020: Joint EFSPI / BBS Webinar: The application of estimands from a Neuroscience perspective
Agenda
Recording
| Hans Ulrich Burger |
Roche, Basel |
Welcome and introduction to the estimand framework |
link |
| Nikolaos Sfikas |
Novartis, Basel |
Outline of an estimand strategy in MS |
link |
| Mette Krog Josiassen and Peter Quarg |
Lundbeck and Novartis |
Outline of an estimand proposal in migraine prevention and neuropathic pain |
link |
| Paul Delmar |
Roche, Basel |
Using the Estimand Framework to address challenges in AD clinical trial with a closer look at the hypothetical strategy |
link |
| Carrie Li |
Roche, Basel |
Estimands in Huntington’s disease |
link |
| Andrew Hartley |
PPDI |
Impact of Covid-19 on studies in Neuroscience |
link |
| Joel Raffel and Khadija Rantell |
MHRA, UK |
Regulatory aspects of the estimand framework: Clinical and statistical perspectives |
link |
| Anja Schiel |
Chair Scientific Advice Working Party, EMA |
Panel discussion including all speakers |
link |
07.09.2020: BBS Webinar RCTs meeting causal inference: principal stratum strategy and beyond
Agenda
Recording
| Kaspar Rufibach |
Roche, Basel |
Welcome and scene setting |
link |
| Vanessa Didelez |
Keynote speaker, Leibniz Institute for Prevention Research and Epidemiology, BIPS, Bremen |
Time-Varying Treatments in Observational Studies: Lessons for Clinical Trials |
link |
| Jack Bowden |
University of Exeter |
Connecting Instrumental Variable methods for causal inference to the Estimand Framework |
link |
| Kelly van Lancker |
Ghent University |
Efficient, doubly robust estimation of the effect of dose switching for switchers in a randomised clinical trial |
link |
| Björn Bornkamp |
Novartis, Basel |
Principal Stratum Strategy: Potential Role in Drug Development |
link |
| Dominik Heinzmann |
Roche, Basel |
Principal stratum strategy to investigate anti-drug antibody impact on cancer immunotherapy outcome |
link |
| Aiesha Zia |
Novartis, Basel |
Exploring estimation approaches for principal stratum estimands in Phase III randomized trials in CAR-T anti-cancer therapy |
link |
| Fabrizia Mealli |
University of Florence |
The ICH E9 addendum from an academic causal inference perspective and feedback on the previous talks |
link |
| Giusi Moffa |
University of Basel |
Next webinars and closure |
link |
| All |
|
Question and Answers |
link |
30.06.2020: BBS/EFSPI Webinar on HTA
Agenda
Recording
| Chrissie Fletcher |
GSK, UK |
Celebrating 10 Years HTA SIG |
link |
| Christoph Schürmann |
IQWiG, Germany |
Health-related quality of life endpoints in benefit assessments: Demands and challenges as seen by IQWiG in Germany |
link |
| Lara Wolfson |
Merck, USA |
Issues related to transparency with HTA dossiers |
link |
| Mark Nuijten |
A2M and Univ. of Maastricht, NL & ITU, Turkey |
An innovative pricing model to assess the price of expensive drugs with an orphan indication |
link |
| Fred Sorenson |
Xcenda |
Introduction to moderated panel discussion |
link |
29.06.2020: Joint EFSPI / BBS Webinar: Estimands addendum is final: Anything new for oncology?
Agenda
Recording
| Kaspar Rufibach |
Roche, Basel |
Welcome and scene setting |
link |
| Anja Schiel |
Chair Scientific Advice Working Party, EMA |
Experience with the estimand framework in oncology |
link |
| Renaud Capdeville |
Novartis, Basel |
Challenges and open questions in hematology: RATIFY |
link |
| Tina Nielsen |
Roche, Basel |
Challenges and open questions in hematology: GALLIUM |
link |
| Hannes Buchner and Ingolf Griebsch |
Staburo and Boehringer-Ingelheim |
Treatment switching: challenges, estimands, and estimators |
link |
| Stefan Englert |
Abbvie |
Commentary on previous talks taking COVID-19 into account |
link |
| All |
|
Question and Answers |
link |
03.06.2020: BBS Webinar: Aspects of COVID-19 pandemic
Agenda
No recording available
| Jean Lang |
Sanofi Pasteur |
Overview on SARS-CoV2 and Challenges for COVID-19 Vaccine Development at Pandemic Speed |
link |
| Christian Althaus |
ISPM, University of Bern |
Early transmission, pandemic spread and severity of COVID-19 |
link |
| Karin Meiser |
Novartis, Basel |
Specific aspects of a clinical trial targeting Covid-19 |
link |
| Jenny Devenport |
Roche, Basel |
The influence of investigator initiated studies in the COVID-19 pandemic |
link |
06.05.2020: BBS Virtual Seminar: Impact of COVID-19 on clinical trials
Agenda
No recording available
| Frank Petavy |
EMA |
EMA perspective and guidance on COVID-19 |
link |
| Natalie Dimier |
Roche, Welwyn |
Industry perspective on COVID-19 (1/3) |
link |
| Mouna Akacha |
Novartis, Basel |
Industry perspective on COVID-19 (2/3) |
link |
| Cristina Sotto |
J&J |
Industry perspective on COVID-19 (3/3) |
link |
| Marcel Wolbers |
Roche, Basel |
Short Overview of Pharmaceutical Industry COVID-19 Biostatistics Working Group |
link |
| Evgeny Degtyarev |
Novartis, Basel |
Short overview on COVID-19 from the Cross-Industry Oncology Estimands Working Group |
link |
01.11.2019: BBS Seminar: Predictive modelling, machine learning and causality
Agenda
No recording available
Summary of the event
| Ewout Steyerberg |
|
Clinical prediction models in the age of artificial intelligence and big data |
link |
| Willi Sauerbrei |
|
The EQUATOR networkand guidelines for prediction models |
link |
| Torsten Hothorn |
|
Score-based transformation learning |
link |
| Peter Bühlmann |
|
Causal regularization for distributional robustness and replicability |
link |
| Giusi Moffa |
|
Predicting putative intervention effects after causal structure learning from survey data |
link |
| Andrew Shattock |
|
Using machine learning and disease models to evaluate target product profiles of novel interventions (No slide deck available) |
No presentation available (may be added later for recent events, after having received speaker approval) |
| Federico Mattiello |
|
Identifying high-risk patients in Non-Hodgkin lymphoma (and trying to get insights into the disease biology) |
link |
| Mark Baillie |
|
Novartis benchmarking initiative: making sense of AI |
link |
| Chris Harbron |
|
Experiences from running internal prediction challenges within a pharmaceutical company |
link |
21.08.2019: BBS/BES Seminar: Causal inference in drug development: why, when, how?
Agenda
No recording available
| Miguel Hernan |
|
Beyond intention-to-treat. Causal inference guidelines for causal inference |
link |
| Christine Fletcher |
|
The Final ICH E9(R1) E9 addendum |
link |
| Frank Pétavy |
|
A regulator’s perspective |
No presentation available (may be added later for recent events, after having received speaker approval) |
| Valentine Jehl |
|
Adverse reactions confounded by prior medication: (how) can causal inference solve the problem? |
No presentation available (may be added later for recent events, after having received speaker approval) |
| Thibaut Sanglier |
|
Treatment sequencing and effectiveness: challenges and considerations |
No presentation available (may be added later for recent events, after having received speaker approval) |
| Nikolaos Sfikas |
|
Principal stratification techniques in the context of regulatory decision making |
No presentation available (may be added later for recent events, after having received speaker approval) |
| Jack Bowden |
|
Implementing the Principal Stratum estimand strategy using Instrumental Variable methods: An emulation of the CANTOS trial |
link |
04.06.2019: BBS/EFSPI Seminar: Precision medicine in drug development
Agenda
No recording available
| Niko Beerenwinkel |
|
Bioinformatics for precision oncology |
No presentation available (may be added later for recent events, after having received speaker approval) |
| Stephen Senn |
|
Precision medicine: The honeymoon is over. It’s high time for tough love |
link |
| Tomasz Burzykowski |
|
Generalized pairwise comparisons for precision medicine |
link |
| Adam Heathfield |
|
Valuation of Regenerative Medicine/Advance Therapeutics (RM/ATs): Challenges and opportunities for creating a better framework |
link |
| Jack Kuipers |
|
Mutational interactions define novel cancer subgroups: can they inform precision oncology? |
link |
| Mario Ouwens |
|
Difficulties with network meta-analysis when starting to use PDL1 thresholds |
link |
| Georgina Bermann |
|
Cardiovascular medicine: approaches to the use of early biomarker response to identify a patient subgroup with enhanced therapeutic benefit |
link |
| Laurent Essioux |
|
Examples of personalized Healthcare at Roche: statistical perspectives |
link |
10.05.2019: BBS Spring Seminar: Synthetic controls - what do we need and how far can we go?
Agenda
No recording available
| Tom Brookland |
|
RWD/RWE Global Regulatory Overview |
link |
| Kaspar Rufibach and Hans Ulrich Burger |
|
External controls in drug development |
link |
| Somnath Sarkar |
|
Considerations for Developing External Control Arm from Real-World Data |
link |
| Laurence Colin and Yue Li |
|
Making better use of early phase safety data |
link |
| Cornelia Dunger-Baldauf |
|
For the sake of the patient – reducing placebo exposure by using historical controls |
link |
| Gonzalo Duran-Pacheco |
|
Electronic Health Records used to derive Control Arms for Single-Arm oncology trials: Proof of concept using RCT’s in lung cancer |
link |
| Chris Harbron |
|
A Decision Making Framework For Utilising External Control Arms |
link |
| Meinhard Kieser |
|
Synthetic controls – what do we need and how far can we go? Rejoinder |
link |
| Norbert Benda |
|
Synthetic controls – what do we need and how far can we go? Rejoinder |
link |
| Kit Roes |
|
Synthetic controls – what do we need and how far can we go? Rejoinder |
link |
| Jan Müller-Berghaus |
|
Synthetic controls – what do we need and how far can we go? Rejoinder |
No presentation available (may be added later for recent events, after having received speaker approval) |
| Anja Schiel |
|
Synthetic controls – what do we need and how far can we go? Rejoinder |
No presentation available (may be added later for recent events, after having received speaker approval) |
27.06.2018: BBS/EFSPI Seminar: Small populations and level of evidence
Agenda
No recording available
| Fred Sorensen |
|
European Statistical Meeting on Small populations and level of evidence |
link |
| Daniel O’Connor |
|
Rare diseases and orphan drugs: A Regulator’s (clinical)Perspectives |
link |
| Stephen Senn |
|
In search of the lost loss function |
link |
| Henriette Thole |
|
The potential and challenges of registry use when generating evidence in small populations |
link |
| Anja Schiel |
|
Rare diseases and orphan drugs:The HTA perspective |
link |
| Adele Morganti |
|
Borrowing external controls for an event-driven pediatric trial in PAH: a case study |
link |
| Andreas Kaiser |
|
Bayesian analysis for small sample size trials using informative priors derived from historical data |
link |
| Elina Asikanius |
|
Using a non-interventional study to strengthen the evidence collected in a Phase III program: a Hemophilia A case Study |
link |
| Hans Hockey and Kristian Brock |
|
Hockey sticks and broken sticks – a design for a single-treatment double-blind randomized clinical trial suitable for chronic diseases |
link |
26.06.2018: BBS Seminar: RCTs, personalized medicine, and surrogacy
Agenda
No recording available
| Tomasz Burzykowski |
|
Evaluation of Time-to-event Surrogate Endpoints Using Accelerated Failure-time Models |
link |
| Everardo D. Saad |
|
Precision Medicine Needs Randomized Trials |
link |
| Marc Buyse |
|
A statistical approach for personalized medicine and benefit / risk assessment |
link |
17.04.2018: BBS Spring Seminar: New developments in HTA, adaptive designs and multiplicity – in remembrance of Willi Maurer
Agenda
No recording available
| Jason Wang |
|
Sense and sensibility of estimands for health technology assessment (HTA) |
link |
| Christoph Gerlinger |
|
EQ-5D-5L Utility Index for different countries |
link |
| Susan Edwards |
|
Whose perspective? Implications on cost-effectiveness modelling of differences between country value sets (a case study) |
link |
| Carsten Schwenke |
|
Real World Evidence and HTA – Experiences with IQWiG |
link |
| Tim Friede |
|
HTA AND SAFETY Some results of the ATF / APF Project Group |
link |
20.03.2018: BBS Seminar: Competing Risks and Multi-State Models
Agenda
No recording available
| Claudia Schmoor |
|
Competing risks with applications to oncology |
link |
| Jan Beyersmann |
|
Analysis of co-time-to-event outcomes in randomized clinical trials |
link |
| Ekkehard Glimm and Lillian Yau |
|
A discrete semi-Markov model for the effect of need-based treatments on the disease states |
link |
14.11.2017: BBS Seminar: Future of Biomedical Research: Are we ready?
Agenda
No recording available
| Damian Roqueiro |
Machine Learning and Computational Biology Lab ETH Zurich |
Applications of Machine Learning and Deep Learning |
No presentation available (may be added later for recent events, after having received speaker approval) |
| Jonas Dorn |
Novartis, Basel |
Machine learning when the ground truth isn’t truth and privacy is a problem – case study from the Assess MS project |
No presentation available (may be added later for recent events, after having received speaker approval) |
| Hans Ulrich Burger |
Roche, Basel |
Big clinical data: What should biometrician do with it? |
No presentation available (may be added later for recent events, after having received speaker approval) |
11.09.2017: BBS Seminar Emerging topics for statistical methodology in drug development: Estimands and advanced analytics
Agenda
No recording available
| Stephen Ruberg |
Eli Lilly |
The patient perspective – the estimands they want |
No presentation available (may be added later for recent events, after having received speaker approval) |
| Stef van Buuren, |
Netherlands Organisation for Applied Scientific Research and University of Utrecht |
Individual causal effect: What is it? Why we need it? How to estimate it? |
No presentation available (may be added later for recent events, after having received speaker approval) |
| Baldur Magnusson |
Novartis, Basel |
Using principal stratification to disentangle post-randomization outcomes in a randomized controlled phase 3 study |
No presentation available (may be added later for recent events, after having received speaker approval) |
| Teresa Barata |
Roche, Basel |
Estimands in early Parkinson disease |
No presentation available (may be added later for recent events, after having received speaker approval) |
| Stephen Ruberg |
Eli Lilly |
Making what’s advanced today routine tomorrow |
No presentation available (may be added later for recent events, after having received speaker approval) |
| Jouni Kerman |
Google |
Causal Measurement using Geo Experiments in a Time-Based Regression Framework |
No presentation available (may be added later for recent events, after having received speaker approval) |
| Cornelia Dunger-Baldauf |
Novartis, Basel |
A Smartphone-Based Study Capturing Longitudinal Vision Test Data, Movement Scores and User-reported Outcomes |
No presentation available (may be added later for recent events, after having received speaker approval) |
| Fabio Pellegrini |
Biogen |
Individualized medicine based on a treatment response continuous score |
No presentation available (may be added later for recent events, after having received speaker approval) |
26.06.2017: BBS Seminar Innovative model-based dose escalation designs: what next?
Agenda
No recording available
| Daniel Sabanés Bové |
|
Model-based D/E designs: Current status and next steps |
link |
| Daniel Lorand |
|
Tailoring dose escalation designs to early clinical development goals |
link |
| Andreas Krause |
|
Guiding dose escalation studies in Phase 1 with unblinded modeling |
link |
15.06.2017: BBS / PSI 1-Day Scientific Meeting: Empower the immune system to fight cancer
Agenda
No recording available
| Jorge Martinalbo |
|
Realising the potential of cancer immunotherapy |
link |
| Andrew Stone |
|
Statistical issues in the development of cancer immunotherapy |
link |
| Daniel Sabanés Bové |
|
Bayesian Learning in Early Phase Cancer Immunotherapy: A Case Study |
link |
| Matt Whiley |
|
An adaptive phase II basket trial design |
link |
| Dominik Heinzmann |
|
Statistical, clinical and ethical considerations when minimizing |
link |
| Claude Berge |
|
Statistical Challenges in Immunotherapy: Non Proportional Hazard Model |
link |
| Sergio Fracchia |
|
Challenges in development and approval: the case of cell based therapeutics |
link |
| Fred Sorenson |
|
Cancer Immunotherapy from the Health Technology Assessment (HTA) and Payer Perspectives |
link |
| Nicholas Latimer |
|
Estimating survival benefit for health technology assessment: New challenges presented by immuno-oncology treatments? |
link |
05.05.2017: BBS Spring Seminar The use of external data for decision making
Agenda
No recording available
| David Evans |
|
Reality and Real-World Data |
link |
| Ralf Bender |
|
Use of registries and observational data in the benefit assessment of medical interventions |
link |
| Frank Bretz |
|
Threshold-crossing: A Useful Way to Establish the Counterfactual in Clinical Trials? |
link |
| David Dejardin |
|
Dynamic borrowing of historical data: Performance and comparison of existing methods based on a case study |
link |
| Eva-Maria Didden |
|
GetReal: 3 Years on! |
link |
| Tim Friede |
|
The Use of External Data for Decision Making |
link |
13.03.2017: BBS Seminar: Biomarker analyses
Agenda
No recording available
| Werner Vach |
Universitätsspital Basel |
Statistical perspectives on umbrella trials |
No presentation available (may be added later for recent events, after having received speaker approval) |
| Kaspar Rufibach |
Roche, Basel |
Comparison of clinical development plans for a confirmatory trial with subpopulation selection |
link |
29.11.2016: BBS Seminar: Safety monitoring during the life cycle of a drug
Agenda
No recording available
| Conny Berlin |
|
Safety monitoring during the life cycle of a drug |
link |
| Yusuf Tanrikulu |
|
Signal Detection – Quantitative Analysis of Safety Data |
link |
| Pritibha Singh |
|
Adverse Drug Reaction (ADR) screening in clinical trials |
link |
| Gianmario Candore |
|
Screening for adverse reactions in EudraVigilance |
link |
| Soheila Aghlmandi |
|
Choice of priors in rare events meta-analysis |
link |
17.10.2016: BBS Seminar: Missing Data and Graphical Models
Agenda
No recording available
| Jane Hutton |
Uni Warwick |
Missing data and how to see biased results using Chain Event Graphs |
No presentation available (may be added later for recent events, after having received speaker approval) |
| Giusi Moffa |
Novartis, Basel |
Cancer profiling and subtype discovery with Bayesian inference for acyclic digraphs |
No presentation available (may be added later for recent events, after having received speaker approval) |
| Markus Elze |
Roche, Basel |
Propensity scores methods and covariate adjustment in practice |
No presentation available (may be added later for recent events, after having received speaker approval) |
14.09.2016: PSI/BBS One Day Meeting: Time-to-Event and Recurrent Event Endpoints
Agenda
No recording available
| Lilla Di Scala |
Actelion, Basel |
Informative censoring in a rare disease: a regulatory experience in PAH |
No presentation available (may be added later for recent events, after having received speaker approval) |
| Dominic Magirr |
AstraZeneca |
Unblinded sample-size reassessment in time-to-event clinical trials |
No presentation available (may be added later for recent events, after having received speaker approval) |
| Tobias Bluhmki |
Universität Ulm |
Analyzing non-monotonous time-to-event outcome probabilities in randomized clinical trials |
No presentation available (may be added later for recent events, after having received speaker approval) |
| Jennifer Rogers |
University of Oxford |
The analysis of recurrent events: A summary of methodology |
No presentation available (may be added later for recent events, after having received speaker approval) |
| Mouna Akacha |
Novartis, Basel |
Recurrent event data endpoints in chronic heart failure studies: What is the estimand of interest? |
No presentation available (may be added later for recent events, after having received speaker approval) |
| Ekkehard Glimm |
Novartis, Basel |
Sample size and interim analysis considerations for recurrent event data analyses |
No presentation available (may be added later for recent events, after having received speaker approval) |
04.05.2016: BBS Seminar: Adaptive Designs
Agenda
No recording available
| Franz König |
|
Regulatory and methodological issues in adaptive designs for confirmatory trials |
link |
| Peter Bauer |
|
DMC membership experience |
link |
| David Lawrence |
|
Using a DMC for dose selection in a phase IIb/III adaptive design: the INHANCE study |
link |
| Alexander Strasak |
|
Adaptive seamless phase II/III study in gastric cancer |
No presentation available (may be added later for recent events, after having received speaker approval) |
28.04.2016: BBS Spring Seminar
Agenda
No recording available
| Kaspar Rufibach |
|
Event projection: quantify uncertainty and manage expectations of broader teams |
link |
| Beat Neuenschwander |
|
Predicting milestone events for time-to-event trials |
link |
| Melissa Penny |
|
Model-based public health impact and cost-effectiveness estimates informing the WHO recommendation on malaria vaccine RTS |
No presentation available (may be added later for recent events, after having received speaker approval) |
| Iain Bennett |
|
Designing in Treatment Switching (case study review and recommendations) |
link |
| Viktoriya Stalbovskaya |
|
Practical aspects of handling treatment switching in randomized clinical trials |
link |
| Daniel Sabanes |
|
Cancer immunotherapies: Which efficacy endpoints and statistical analyses to use? |
link |
| Andrew Stone |
|
Non-Proportional Hazards – So What? |
link |
| Karine Lheritier |
|
Complex study design in patients with Hereditary Periodic Fevers |
No presentation available (may be added later for recent events, after having received speaker approval) |
| David Dejardin |
|
Bayesian dual endpoint decision making in combination studies |
link |
| Alessandro Matano |
|
Bayesian approach for Combination Phase I Trials in Oncology |
No presentation available (may be added later for recent events, after having received speaker approval) |
13.01.2016: BBS Seminar: Disease and Product Registries
Agenda
No recording available
| Tim Friede |
|
Clinical registries: Use and Emerging Best Practices |
link |
| Eva‐Maria Didden |
|
Learning and Predicting Real‐World Treatment Effect based on Randomized Controlled Trials and Registry Data – A Case Study in Rheumatoid Arthritis |
link |
| Heiner C. Bucher |
|
Making Better Use of Registry Data in Designing Pragmatic Trials |
link |
| Yvonne Geissbühler |
|
Use of Registries to Collect Pregnancy Data |
link |
| Brian Hennessy |
|
Registries in Rare Diseases / Orphan Drugs along with 2 Case Studies |
No presentation available (may be added later for recent events, after having received speaker approval) |
| Helene Karcher |
|
Leveraging Real‐World Registry Data to Optimize the Design of Phase 3 Studies – a Case Study in Schizophrenia |
link |
27.10.2015: BBS Seminar: Prediction
No agenda available
No recording available
| Kaspar Rufibach |
|
Bayesian Predictive Power: the bathtub problem |
link |
| Evgeny Degtyarev |
|
Designing Phase 2 to predict success in Phase 3 study |
No presentation available (may be added later for recent events, after having received speaker approval) |
23.06.2015: Joint BBS/EFSPI Seminar: Health Technology Assessment
Agenda
No recording available
| Chrissie Fletcher & Matthias Egger |
Amgen & University of Bern |
IMI GetReal Initiative Update |
No presentation available (may be added later for recent events, after having received speaker approval) |
| Panelists |
|
Expert panel discussion on trends and burning issues, eg. Structured benefit risk and real world evidence; dual EMA-HTA consultation |
No presentation available (may be added later for recent events, after having received speaker approval) |
| Pascale Brasseur |
Medtronic |
Overview of HTA for medical devices and diagnostics |
No presentation available (may be added later for recent events, after having received speaker approval) |
| Sheryl Warttig |
NICE |
NICE’s approach to the development of guidance for medical devices and diagnostics |
No presentation available (may be added later for recent events, after having received speaker approval) |
| Karsten Berndt |
Roche Diagnostics |
EUnetHTA core model applied to Colorectal Cancer screening |
No presentation available (may be added later for recent events, after having received speaker approval) |
| Valéry Risson |
Novartis |
Uses of Social Media for Outcomes Research – results of a real-world pilot |
No presentation available (may be added later for recent events, after having received speaker approval) |
| Claire Watkins |
AstraZeneca |
Adjusting overall survival for treatment switch/crossover |
No presentation available (may be added later for recent events, after having received speaker approval) |
| Pierre Ducorneau |
Roche, Basel |
Using the EUnetHTA HTA core model as a framework for planning, generating and presenting evidence |
No presentation available (may be added later for recent events, after having received speaker approval) |
| Yovanna Castro |
Roche, Basel |
Predicting long term survival using nonparametric Bayesian methods: the melanoma case |
No presentation available (may be added later for recent events, after having received speaker approval) |
| Nathalie Barbier |
Novartis |
Reimbursement challenges with new emerging cancer therapies |
No presentation available (may be added later for recent events, after having received speaker approval) |
| Won Lee |
Xcenda |
The value of Oncology therapies and emerging access hurdles in Canada and the United States |
No presentation available (may be added later for recent events, after having received speaker approval) |
13.04.2015: BBS Seminar: Bayesian Methods in Adaptive Dose-Finding Trials
Agenda
No recording available
| Daniel Sabanes Bove |
|
Bayesian Learning in Oncology: A Case Study |
link |
| Ying Yuan |
|
Bayesian Data Augmentation Continual Reassessment Method (DA-CRM) for Phase I Trials with Delayed Toxicities |
link |
| Daniel Lorand |
|
Bayesian modelling for combination dose-escalation trial that incorporates pharmacokinetic data |
link |
13.11.2014: Joint BBS-EFSPI Seminar: Data Sharing in Clinical Development
Agenda
No recording available
| Sabine Atzor |
|
Clinical Trial Data Transparency – Environment & Expectations |
link |
| Stefan Driessen |
|
EFSPI position on EMA policy on publication of clinical data |
link |
| Franz König |
|
Big thunder |
link |
| Rebecca Sudlow |
|
Overview of Data Sharing Initiatives in Industry and Current Experiences |
link |
| Janice Branson |
|
Practicalities of accessing and using data – Advice for Researchers |
link |
| Sally Hollis |
|
Considerations for analysis plans for data sharing requests |
link |
| Katherine Tucker |
|
Principles to maintain patient confidentiality+H211 |
link |
| Guilliaume Breton |
|
Patient Confidentiality Implementation |
link |
07.05.2014: BBS Seminar: Applications for statisticians working with “Real-World Data”
Agenda
No recording available
| Pamela Landsman-Blumberg |
|
Applications for statisticians working with “Real-World Data” |
No presentation available (may be added later for recent events, after having received speaker approval) |
| Fred Sorensen |
|
|
No presentation available (may be added later for recent events, after having received speaker approval) |
04.02.2014: BBS seminar: Adaptive / Flexible Designs in early development
No agenda available
No recording available
No slides available ::: {.cell}
:::
04.06.2013: Joint BBS/EFSPI Seminar: Health Technology Assessment
Agenda
No recording available
| Mike Branson |
|
Welcome |
link |
| Fred Sorenson |
|
Health Technology Assessment – Why is it so important? |
link |
| Matthias Egger and Mike Chambers |
|
Moving HTA forward: The challenges of incorporating real world evidence into Health Technology Assessment |
link |
| Mike Chambers and Matthias Egger |
|
GetReal: Clinical effectiveness in drug development |
link |
| Claudia Nicolay |
|
Health Technology Assessment – What’s in for Stats? |
link |
| Jens Grüger |
|
HTA and personalized healthcare |
link |
| Skip Olson |
|
HTA – Use of observational |
link |
| Bruno Falissard |
|
The place of subjectivity in the French system (HAS): a good thing or an archaism? |
link |
| Ralf Bender |
|
Biometrical topics of Health Technology Assessment in Germany |
link |
| Friedhelm Leverkus |
|
30 Months AMNOG Health Technology Assessment: Outcomes and Issues |
link |
| Lou Garrison |
|
HTA in Emerging Markets: A Framework and Examples |
link |
| Richard Nixon |
|
Using early health economic models to support drug development decisions |
link |
| Chrissie Fletcher |
|
Using indirect treatment comparisons to support an HTA |
link |
| All |
|
Summary of event |
link |
28.11.2012: BBS Seminar: Optimal Design for Non-linear Models
Agenda
No recording available
| Anthony Atkinson |
London School of Economics |
Experiments for Building Enzyme Kinetic Models |
No presentation available (may be added later for recent events, after having received speaker approval) |
| Tobias Mielke |
Aptiv Solutions |
Optimal Population Designs for Non-linear Mixed Effects Models |
No presentation available (may be added later for recent events, after having received speaker approval) |
| Barbara Bogacka |
Queen Mary College, University of London |
Population Optimum Design for Non-linear Mixed Effects Models in the Presence of Covariates |
No presentation available (may be added later for recent events, after having received speaker approval) |
25.09.2012: BBS Seminar: Benefit-Risk & Comparative Effectiveness
Agenda
No recording available
| Andrea Beyer |
|
Understanding the risk tolerance of regulatory assessors in Europe: the role of quantitative models in risk communication |
link |
| Christoph Dierig and Richard Nixon |
|
A case study using the BRAT framework for benefit risk assessment |
link |
| Christian Hove Rasmussen |
|
Benefit-risk assessment from a clinical point of view: a structured approach with focus on transparency |
link |
| Ralf Bender |
|
Biometrical requirements in (early) benefit assessments |
link |
| Fred Sorenson |
|
Benefit-risk assessment and comparative effectiveness research: are they really converging? |
link |
09.07.2012: BBS Seminar: Emerging Topics in Pharmaceutical Statistics
Agenda
No recording available
| Stephen A. Julious |
|
Sample sizes for multiple must-win trials |
link |
| Eric Derobert |
|
A parameterized strategy of gatekeeping |
link |
| Mouna Akacha & Günther Müller-Velten |
|
Recurrent event approaches in cardiovascular outcome trials |
No presentation available (may be added later for recent events, after having received speaker approval) |
| Lisa Hampson |
|
Group sequential tests for delayed responses |
link |
22.05.2012: BBS Seminar: Experiences in the Development and Implementation of Flexible Designs
No agenda available
No recording available
No slides available ::: {.cell}
:::
29.11.2011: BBS Seminar
Agenda
No recording available
| Boris Choy |
Business School The University of Sydney |
Nonignorable dropout models for longitudinal binary data with random effects: An application of Monte Carlo approximation through the Gibbs output |
No presentation available (may be added later for recent events, after having received speaker approval) |
| Mouna Akacha |
Novartis, Basel |
Implementing Current Regulatory Guidance on the Treatment of Missing Data: An Industry Perspective |
No presentation available (may be added later for recent events, after having received speaker approval) |
16.09.2011: BBS Fall Conference: Current Topics in Pharmaceutical Statistics: Dose Finding and Multiregional Trials
Agenda
No recording available
| Andy Grieve |
|
Dose Selection in Drug Development: What Can Go Wrong? Can we put it Right? |
link |
| Didier Renard |
|
Use of modeling & simulation to support design and analysis of a new dose and regimen finding study |
link |
| Bjoern Bornkamp |
|
On the efficiency of two-stage adaptive designs |
link |
| Georg Gutjahr |
|
Powerful Modification of Step Down Procedures for Dose Finding |
No presentation available (may be added later for recent events, after having received speaker approval) |
| H.M. James Hung |
|
Planning and Analyzing Multi-regional Clinical Trials: A Regulatory Perspective |
link |
| Philip Hougaard |
|
Global drug development strategies |
link |
| Jorgen Seldrup |
|
Designing clinical trials in a multiregional regulatory environment |
No presentation available (may be added later for recent events, after having received speaker approval) |
| Kevin J. Carroll |
|
Consistency of treatment effect across regions in a multi-regional trial: reasonable goal or unrealistic requirement? |
link |
21.07.2011: BBS Seminar Quantitative Benefit-Risk: What Matters to Whom and How? – Getting the Values and Weights
Agenda
No recording available
| John Ferguson |
|
Structured Benefit-Risk Optimization (BRO): A Framework Quantitative Decision Support Tools |
link |
| Gordon Francis |
|
Clinical Perspective on Benefit-Risk Assessments |
link |
| Lawrence Phillips |
|
Quantitative Benefit-Risk: Determining Values & Assessing Weights |
link |
| Andrea Beyer |
|
Beyond the Probability of Risk: Measuring Perception |
link |
10.05.2011: BBS Spring Conference: Comparative Quantitative Assessments: Benefit-Risk & Effectiveness
Agenda
No recording available
| Chrissie Fletcher |
|
Industry Perspective on Comparative Effectiveness Research (CER) and the impact of Health Technology Assessment (HTA) in Europe |
link |
| Melvin (Skip) Olson |
|
Some Issues with Indirect Comparisons |
link |
| Friedhelm Leverkus |
|
Health Care Reform in Germany and Update on IQWiG Requirements |
link |
| John Doyle |
|
Effect of Comparative Effectiveness Research on Drug Development Innovation: a 360° Appraisal and Summary Discussion |
link |
| Deborah Ashby |
|
Current Methodological Approaches to Benefit-Risk Decision-Making |
link |
| John Ferguson |
|
Structured Benefit-Risk Optimization (BRO): State-of-the-art and Role of Fully Quantitative Decision Support Tools |
link |
| Michael Forstner |
|
Considerations for Implementing a Quantitative Benefit-Risk Assessment |
link |
| Richard Nixon |
|
Benefit-Risk Assessment of Multiple Sclerosis Treatments: Lessons Learnt in the use of Multi-Criteria Decision Analysis |
link |
| John Doyle |
|
Convergence of CER and BRA and Concluding Summary Discussion |
link |
07.05.2011: BBS Spring Seminar: Multiplicity in Clinical Trials
Agenda
No recording available
| Huque Mohammad |
|
Some key multiplicity questions on primary and secondary endpoints of RCCTs and possible answers |
link |
| Ferber Georg |
|
Confirmatory statistics in PK/PD studies |
link |
| Kornelius Rohmeyer |
|
gMCP: A GUI for graphical multiple test procedures |
No presentation available (may be added later for recent events, after having received speaker approval) |
| Wolf Michael |
|
Control of the false discovery rate under dependence using the bootstrap and sub sampling |
link |
| Maurer Willi / Glimm Ekkehard |
|
Multiple and repeated testing of primary |
link |
13.01.2011: BBS Seminar: Statistical Challenges in Biomedical Research
Agenda
No recording available
| Kalisch Markus |
|
Can one extract causal information from high-dimensional observational data? |
link |
| Sauerbrei Willi |
|
Regression model-building with continuous variables – multivariable fractional polynomials |
link |
30.11.2010: BBS Seminar
Agenda
No recording available
| Harald Binder |
|
Fitting and evaluating risk prediction models with high-dimensional molecular data |
No presentation available (may be added later for recent events, after having received speaker approval) |
| Martin Wolkewitz |
|
Healthcare epidemiology hospital-acquired infections statistical modeling of outbreaks |
No presentation available (may be added later for recent events, after having received speaker approval) |
04.10.2010: BBS Fall Conference
Agenda
No recording available
| Helmut Schäfer |
University of Marburg |
Optimized and flexible designs for genome-wide associations studies |
No presentation available (may be added later for recent events, after having received speaker approval) |
| Maximo Carreras |
Roche, Basel |
Point Estimation in Two-Stage Adaptive Designs With Mid-Trial Treatment Selection |
No presentation available (may be added later for recent events, after having received speaker approval) |
| David Lawrence |
Novartis, Basel |
The A to Z of DMC interaction in a phase II/III adaptive design with treatment selection |
No presentation available (may be added later for recent events, after having received speaker approval) |
| Reinhard Eisebitt |
ClinResearch |
Methods to protect the blinding, including controlled emergency unblinding, in adaptive design trials with flexible randomization schemes |
No presentation available (may be added later for recent events, after having received speaker approval) |
| Tim Friede |
University of Göttingen |
The role of DMCs in adaptive design trials: The perspective of a DMC member |
No presentation available (may be added later for recent events, after having received speaker approval) |
| Sue-Jane Wang |
FDA |
Adaptive Design Consideration: A Regulatory Perspective on How to Maintain Validity and Integrity of Trials |
link |
| James Hung |
FDA |
Emerging Challenges in Design and Analysis of Non-inferiority Trials |
link |
| Franz König |
EMA |
|
No presentation available (may be added later for recent events, after having received speaker approval) |
| Ralf Bender |
IQWiG |
The importance of Non-inferiority testing in benefit assessments of medical interventions |
link |
| Heinz Schmidli |
Novartis, Basel |
Estimating the placebo-effect in a non-inferiority trial: a case study |
No presentation available (may be added later for recent events, after having received speaker approval) |
| Georg Gutjahr, Werner Brannath, Peter Bauer |
Bremen and Vienna |
Unblinded SampleSize Modification for Fisher’s Exact Test |
link |
24.06.2010: BBS/EFSPI European Statistical Meeting on Oncology
Agenda
No recording available
| Bertil Jonsson |
Medical Products Agency |
Understanding Progression-free Survival |
No presentation available (may be added later for recent events, after having received speaker approval) |
| Marc Buyse |
IDDI and University of Hasselt |
The Time to Progression Ratio for Phase II Trials of Personalized Medicine |
No presentation available (may be added later for recent events, after having received speaker approval) |
| Stuart Bailey |
Novartis, Basel |
Adaptive Bayesian Designs for Phase I Oncology Trials |
No presentation available (may be added later for recent events, after having received speaker approval) |
| Simon Wandel |
Novartis, Basel |
Bayesian Hierarchical Modelling of Clinical Response in NSCLC Subpopulations |
No presentation available (may be added later for recent events, after having received speaker approval) |
| Claire Watkins |
AstraZeneca |
IRESSA: A Journey of Experience from Broad to Biomarker Populations |
No presentation available (may be added later for recent events, after having received speaker approval) |
| Cong Chen |
Merck |
Optimal Cost-Effective Go-No Go Decisions in Late-Stage Oncology Drug Development |
No presentation available (may be added later for recent events, after having received speaker approval) |
| Jonas Wiedemann |
Roche, Basel |
Oncology Dose Finding – A Case Study |
No presentation available (may be added later for recent events, after having received speaker approval) |
28.04.2010: BBS Seminar Epidemiology
Agenda
No recording available
| Noah Jamie Robinson |
Roche, Basel |
Epidemiology: the basics and in practice (at Roche) |
No presentation available (may be added later for recent events, after having received speaker approval) |
| Jim Young |
Basel Institute for Clinical Epidemiology and Biostatistics |
Approximate Bayesian methods for the analysis of epidemiological data |
link |
12.03.2010: BBS Seminar
No agenda available
No recording available
| Benda Norbert |
|
The use of adaptive designs in dose finding studies |
link |
| Brannath Werner |
|
Challenges in the application of adaptive phase II/III designs in oncology |
link |
| Fleischer Frank |
|
Statistical modeling in the context of progression-free survival |
link |
| Friede Tim |
|
Blinded sample size reestimation with count data |
link |
| Glimm Ekkehard |
|
Some lessons learned from designing and adaptive clinical trial with time-to-event as the primary endpoint |
link |
| Guthjahr Georg |
|
Multiple Type I error control in response adaptive Phase II/III designs with treatment selection |
link |
| Wang Sue-Jane |
|
U.S. FDA Draft Guidance on Adaptive Design Clinical Trials – Statistical Considerations and Issues |
link |
12.01.2010: BBS Seminar: Enhanced Statistical Methodology
Agenda
No recording available
| Leonhard Held |
University of Zürich |
A Nomogram for P Values |
No presentation available (may be added later for recent events, after having received speaker approval) |
| Kaspar Rufibach |
University of Zürich |
Estimation of two ordered monotone regression curves |
No presentation available (may be added later for recent events, after having received speaker approval) |
07.12.2009: BBS Seminar: Challenges and Evaluation of Biomarkers
Agenda
No recording available
| Eric Holmgren |
Genentech |
Quantifying the usefulness of PD biomarkers in phase 2 screening trials of oncology drugs |
No presentation available (may be added later for recent events, after having received speaker approval) |
| Martin Schumacher |
Novartis, Basel |
Class prediction with gene expression data |
No presentation available (may be added later for recent events, after having received speaker approval) |
26.10.2009: BBS Seminar: Operational and Implementation Considerations in Adaptive Designs
Agenda
No recording available
| Eva Miller |
ICON Clinical Research |
Logistical Considerations in the Implementation of Adaptive Trial Designs |
No presentation available (may be added later for recent events, after having received speaker approval) |
| Norbert Benda |
Novartis, Basel |
Considerations and Experiences in Adaptive Dose Finding |
No presentation available (may be added later for recent events, after having received speaker approval) |