Menu
This meeting will offer participants the opportunity to interact with speakers from academia, regulatory agencies and industry on recent developments in designing clinical trials. Apart from presentations on a diverse range of topics including the use of modeling and simulation
in designing a study, there will be a formal debate. The motion of the debate is:
“This house believes the arrival of Big Data makes controlled clinical trials obsolete”
Members of the audience are invited to submit short contributions to the debate in writing to the organisers.
Venue: Astellas Pharma Europe B.V., Sylviusweg 62, 2333BE Leiden, Netherlands
To view the event flyer click here
Over the last years progress has been made in statistical methodology for the efficient assessment of safety and efficacy of treatments in small populations. This meeting brings together experts to discuss these methods and the level of evidence that is needed to apply them.
The Basel Biometric Society (BBS) and the European Federation of Statisticians in the Pharmaceutical Industry (EFSPI) are pleased to organize a European Scientific Meeting on this relevant topic. This meeting will provide a forum to hear about the latest development of methods in small populations from representatives from European regulatory bodies, and from practitioners in the pharmaceutical industry and academia.
Venue: Idorsia Pharmaceuticals, Hegenheimermattweg 91, Allschwil, Switzerland
Over the last years progress has been made in statistical methodology for the efficient assessment of safety and efficacy of treatments in small populations. This meeting brings together experts to discuss these methods and the level of evidence that is needed to apply them.
The Basel Biometric Society (BBS) and the European Federation of Statisticians in the Pharmaceutical Industry (EFSPI) are pleased to organize a European Scientific Meeting on this relevant topic. This meeting will provide a forum to hear about the latest development of methods in small populations from representatives from European regulatory bodies, and from practitioners in the pharmaceutical industry and academia.
Venue: Idorsia Pharmaceuticals, Hegenheimermattweg 91, Allschwil, Switzerland
Date:
22nd November 2019
Location:
NV Bristol-Myers Squibb Belgium SA Parc de l’Alliance Avenue de Finlande 4 B – 1420 Braine-l’Alleud Belgium
Description:
Precision medicine aims to tailor disease prevention, diagnosis and treatment to the individual patient, based on their individual features extracted from multiple types of data (such as multi-omics, imaging, patient history, lifestyle and environmental factors).
For the event flyer please Click Here
Date:
Tuesday, June 04, 2019
Location:
Actelion Pharmaceuticals, Hegenheimermattweg 95 Allschwil Switzerland
Description:
Precision medicine aims to tailor disease prevention, diagnosis and treatment to the individual patient, based on their individual features extracted from multiple types of data (such as multi-omics, imaging, patient history, lifestyle and environmental factors).
For the event flyer please Click Here
Date:
20th March 2019
Location:
PGN Conference Centre, AstraZeneca, Pepparedsleden 1431 83 Mölndal, Swedan
Description:
Biomarkers continue to be present in modern drug development. Ideally, they may help scientists to understand why a patient responds in a particular way to treatment. In this meeting, experts from industry, academia and regulatory agencies will come together to share recent insights and discuss these challenges, with a focus on practical applications.
For the event flyer please Click Here
Date:
12 December 2018
Location:
Servier 50 Rue Carnot, F- 92284 Suresnes France
Description:
Taking decisions during the development of a new drug requires combining many and varying pieces of information. The interconnections between them are often only partially known, reflecting the complexity of the context in which drugs are evaluated and the cognitive load required for health care decisions. Decision-makers need quantitative tools to support informed decisions, with transparent processes that synthesize the whole available information in order to evaluate the success associated to different options.
This meeting aims to bring together statisticians from the pharmaceutical industry and academia to hear about recent advances in statistical methods for quantitative decision-making in drug development
For the event program please Click Here
Date: Friday 17th November 2017
Time: 09:30 – 17:00
Venue: NV Bristol – Myers Squibb Belgium SA Parc de l’Alliance Avenue de Finlande 4B – 1420 Braine-l’Alleud Belgium
Survival analysis methods, or ‘Time to event’ methods, are used in many clinical indications for the development, regulatory approval, and health technology assessment of new therapeutics. Originally developed to analyse trial endpoints in oncology, they are now used i n many other indications.
This meeting aims to bring together statisticians from the pharmaceutical industry, academia and regulatory agencies to hear about recent advances in survival analysis methods and their application in oncology.
For further information please download the event flyer – Click Here
Click Here to view the event agenda.
 | 1_Surrogates_E Saad |
| 2_estimandsOncology_Teerenstra |
| 3_Statistical challenges in immunotherapy trials EORTC |
| 4_GPC_Peron_J |
| 5_Teatment Selection_G Rosenkranz |
| 6_Multimarker_F_Rotolo |
| 7_agnes_balogh |
Safety data are the most common and one of the most important type of data collected in clinical trials. However, in general, the emphasis is on the efficacy data. In this meeting, we will take a look at various aspects of safety data in a clinical trial. Colleagues from industry, academia and regulatory agencies will come together to discuss latest developments for statistical analysis of adverse events, current practices in the conduct of data monitoring committees, and related topics on safety data in clinical trials. We will also hear thoughts on personalized safety analyses.
Date: 22nd November 2016
Venue: BMS, Brussels, Belgium
EVIDENCE SYNTHESIS IN DRUG DEVELOPMENT
Network meta-analysis in an ANOVA framework
Frequentist network meta-analysis using the R package netmeta
Network Meta-Analysis using Individual Participant Data – When do benefits arise?
Meta-analysis of case-control studies
Evidence-based trial design: Appraising and using evidence from Network Meta-Analysis
A Case Study: Ipilimumab in Pre-treated Metastatic Melanoma
Date: Tuesday 4th October 2016
Time: 15:00 – 16:30 CET
Together with the Special Interest Group on M&S, EFSPI is organising a Webinar on Best Practice in Modelling and Simulation on Tuesday October 4th 15:00-16:30 CET. This webinar will cover recent proposed Best Practice for M&S which has been accepted for publication in Pharmaceutical Statistics. Speakers will discuss how M&S can be integrated into the drug development process from discovery to post-marketing, and how M&S practitioners can keep to the appropriate best practice, when applications and impact of M&S vary so much. Speakers including Michael O’Kelly, Chris Jennison, Scott Marshall and Tom Parke. These presentations are based on the presentations given at the PSI conference in Berlin in May 2016 and also include new material.
Best Practice in Modelling & Simulation – Intro
Best Practice for Modelling and Simulation: EFSPI Special Interest Group proposal
Date: Friday 24th June 2016
Venue:
Astellas Pharma Europe B.V.,
Sylviusweg 62,
Leiden,
Netherlands
On June 24th, one-day meeting on Biomarkers and Subgroups was held in Astellas B.V. in Leiden. This meeting brought together the experts from industry, academia and regulatory agencies to discuss about the challenges on biomarkers and subgroups.
The event started with a welcome drink; and afterwards the first speaker, Hans-Ulrich Burger (Roche), set the scene for the day providing an overview of subgroup selection for biomarkers. He touched upon the challenges with biomarkers and subgroups, leaving the floor to the other speakers to discuss about these challenges and to provide some recommendations. Afterwards, Norbert Benda (BfArM) presented regulatory view on the Biomarkers and Subgroups. He talked about stratified medicine and a research project on biomarker defined populations. The third speaker, Andrew Grieve (ICON plc), presented adaptive designs for subgroup selection. He focused on “enrichment” designs talking about that “One size fits all” approach may not work well in different situations, giving the example of Type I and II diabetes.
The last speaker before the lunch break was Tim Friede (University Medical Center Gottingen). His talk revolved around the methods for exploration and confirmation of subgroups. In his talk, he mainly focused on meta-analytic techniques, explaining the differences between different estimators for estimating the overall effect in a meta-analysis especially in the case of small number of publications and heterogeneity.
After the lunch break, Andrew Stone (Stone Biostatistics) gave a presentation about Including the Biomarkers in Clinical Development Plans.
Afterwards, Sebastien JobJörnsson, a PhD student from Chalmers University presented optimal trial design for targeted therapies; different example when focusing on full population, enrichment design or a stratified approach The last speaker of the day, Xavier Benain (Sanofi), talked about the Statistical Challenges in Diagnostic Biomarker Qualification. How to confirm diagnostic biomarker best threshold using different techniques (including resampling techniques) in simulations studies.
At the end of the day all speakers were invited to the stage for a panel discussion. There were many questions from the attendees to the speakers during the panel discussion. The speakers agreed on the take home message from the panel discussion: “Pre-specify subgroups”, “Multiplicity is an issue” and “Biological plausibility play an important role”.
The event was very successful with 7 speakers approaching the challenges with biomarkers and subgroups from different perspectives and more than 50 attendees.
Date: Thursday 12th November 2015
Time: 9:30am to 5:30pm
Venue:
NV Bristol-Myers Squibb
Belgium SA
Parc de I’Alliance
Avenue de Finlande 4
B – 1420 Braine-I’Alleud
Belgium
Presentations and Slides
The importance of Health Technology Assessment (HTA) has increased substantially over the last few years. In order to obtain reimbursement, it has become critical for manufacturers to provide additional evidence about their products in a real-world setting to satisfy the requirements of the various national HTA bodies and best guide internal decision-making post market authorization. The Basel Biometric Society (BBS) and the European Federation of Statisticians in the Pharmaceutical Industry (EFSPI) organized a European Scientific Meeting on this relevant topic. The meeting provided a forum to hear about the latest development of methods in the applications of HTA from representatives from European regulatory bodies, and from practitioners in the pharmaceutical industry and academia.
Generating evidence for Health Technology Assessment – Flyer
Early dialogue with HTA agencies
Applying Real-World Data in HTA – Why one size does not fit all
Biometrical issues in the framework of benefit assessment in Germany
Meeting local HTA requirements – challenges for the Pharma statistician
Deriving minimally important difference for PRO data
Designing better observational studies: The role of the pharmaceutical statistician
Analytical Strategy, Credibility and Rigor of Evidence
Subgroups for regulatory vs HTA – methods and perspectives
Survival Analysis – Meeting Agenda
Hein Putter – Landmarking, immortal time bias and dynamic prediction – Presentation
Hein Putter – Landmarking, immortal time bias and dynamic prediction – Handouts
Yolanda Barbachano – Current Regulatory Issues in Survivial Analysis
Kevin Carroll – The use and utility of parametric AFT modelling in the analysis of time data
Veerle de Pril and Tai-Tsang Chen – Statistical Challenges in Immuno-Oncology
Nicola Schmitt – Missing Data in Survival Analysis
Jan Bogaerts and Leen Slaets – One-way optional crossover: biases and analysis approaches
This one-day meeting was informative, enjoyable and smoothly organised. While there is a large amount of recommended reading available online, the clear presentations, with opportunity to hear personal opinions and the subsequent discussion, rewarded any effort made to travel and dedicate the time to understand current thinking in this developing area. Breaks gave opportunity to mix with counterparts from across Europe.
Deborah Ashby (Imperial College, London), co-lead of the risk:benefit package (WP5) within IMI PROTECT, described the remit as improving the monitoring of EU medicines post-approval through the life-cycle of a drug. During the past 4 years this has focussed on methodology and communication within benefit:risk, balancing individual and population-based decision-making, incorporating perspectives of patients, prescriber’s, healthcare providers, regulatory agencies, and manufacturers.
A survey of available acronyms (sorry, techniques and tools) connected with risk assessment were reviewed and categorised into frameworks, metric indices, estimation techniques, and utility survey techniques. Four case studies where the benefit:risk assessment was challenging for regulators were investigated, to apply methodology as a technical exercise for illustration. In each case, four stages were completed:
The communication aspect has considered the care with which clear messages need to be created, and the requirement for provision of in-depth background information to support any headlines.
A rimonabant case study (not discussed further at this meeting) report available online includes an interactive tool to adjust your own preferences. Experience has demonstrated evaluation of benefit:risk to be an iterative process, adapting as opinions are incorporated, initial assessments are reviewed, new data or approaches become available.
Andrew Thomson (MHRA) gave (his own) regulatory perspective. In summary, formalising benefit:risk gives structure to evaluations that were going on already. MHRA now create an “Effects Table” as a top-line summary. In combination with a benefit:risk assessment from an applicant, which helps MHRA understand the company’s position, the areas of agreement and differences are clear which can focus discussion. Documentation of the issues also facilitates handovers between licensing and post-marketing vigilance teams within MHRA, and between rapporteur/co-rapporteur and a third country being included in the mutual recognition process for the benefit:risk assessment. There is still opportunity to improve the understanding of benefit:risk across the group of regulatory agencies. Further motivation for benefit:risk comes from pharmacovigilance legislation requiring thorough PSUR updates with a new risk evaluation for licensed products.
Andrew described the example of Xeljanz, particularly interesting as FDA and MHRA assessments gave differing opinions. The review considered different lines of therapy, combination therapies, and doses, after which FDA granted approval for one dose as second-line therapy, while CHMP refused approval for 3rd line. It was emphasised that MHRA took no account of the oral administration aspect in their review (existing treatment options are infusions).
Rebecca Sudlow (Roche Products Limited) gave her company perspective on implementing structured benefit:risk. It has taken dedicated resource to achieve adoption, but Roche have successfully built a framework, toolkit, guidance that expects teams to document their plans, reasoning, qualitative and quantitative assessments throughout the life of a clinical development programme. The result is an opportunity to move from the traditional reporting summary (Table 1: Impressive efficacy, Table 27 onwards: Safety tables, Conclusion: effective with an acceptable safety profile) to a more integrated approach.
Richard Nixon (Novartis), Ian Hirsch (AstraZeneca), Christine Hallgreen (Imperial College) and Alfons Lieftucht (GSK) each gave case study experience, Richard and Christine using IMI PROTECT examples(natalizumab and telithromycin respectively), and Ian and Alfons internal company examples. Richard illustrated the concept of applying subjective weightings to a single quantity of benefit:risk using the scoring system for the heptathlon: each activity is different with a different scale, how much “improvement” in each is equivalent for comparison? The natalizumab example had a very rare but very serious side effect, and adjustments in weighting for the adverse event compared to those for beneficial variables could be made to identify a tipping point. Common themes were how to source justifiable weights for the model components, how to incorporate the correlations between the efficacy and safety variables being included, and whether a by-patient utility-type quantity across efficacy and safety would be an alternative approach. The presenters were keen to share their progress so far, and support others as they attempt to roll out similar approaches in their organisations, to avoid inefficiencies creating multiple versions of the same guidance documents.
I strongly recommend the IMI PROTECT website with its vast resource of material, including a methodology review and case study reports. I also heartily recommend attending PSI events that match your areas of interest, this was my first for quite a while and it was extremely worthwhile.
Ann Smith (Astra Zeneca)
Meeting Report – Structured Benefit-Risk Assessment
Structured Benefit-Risk Assessment – Flyer
A regulatory perspective of Structured Benefit-Risk – Dr Andrew Thomson (MHRA)
IMI PROTECT case study: Structured Benefit-Risk applied to natalizumab – Dr Richard Nixon (Novartis)
AN IMI PROTECT case study: Telithromycin – Dr Christine Hallgreen
Draft Policy and Setting the Scene – Gerlinger
Systematic Review of Trial Data – Tudur-Smith
MRC Clinical Trial Unit London – Sydes
Health Technology Assessment – Joint BBS/EFSPI Seminar Programme
Health Technology Assessment – What’s in it for Stats?
Get Real:Clinical Effectiveness in Drug Development
Introduction to the use of Observational Data
The Place of Subjectivity in the French System
Biometrical Topics of HTA in Germany
Health Technology in Emerging Markets: A Framework and Examples
Using Early Health Economic Models
Using Indirect Comparisons to Support a HTA
Health Technology Assessment – Summary of Meeting 4th June 2013
Health Technology Assessment – Joint BBS/EFSPI Seminar Programme
Health Technology Assessment – What’s in it for Stats?
Get Real:Clinical Effectiveness in Drug Development
Introduction to the use of Observational Data
The Place of Subjectivity in the French System
Biometrical Topics of HTA in Germany
Health Technology in Emerging Markets: A Framework and Examples
Using Early Health Economic Models
Using Indirect Comparisons to Support a HTA
Health Technology Assessment – Summary of Meeting 4th June 2013
European Statistical Meeting on Subgroup Analyses – Flyer
Statistical Meeting on Subgroup Analyses – Agenda
Subgroup Analyses, Important, Infuriating and Intractable – Rob Hemmings (MHRA)
Biomarker defined subgroups in gastric cancer, a case study – Nigel Baker (AMGEN)
Multiplicity considerations in Confirmatory Subgroup Analysis – Frank Bretz (Novartis)
Genomic Status in Optimizing Subgroup Patient Selection: A case study – Jean-Marie Ledeine (BMS)
Subgroups, clinical sense and statistical challenge – Kit Roes (University Medical Center Utrecht)
Adaptive Clinical Trial Designs for Subgroup Selection – Nigel Stallard (University of Warwick)
European Statistical Meeting on Subgroup Analyses – Flyer
Statistical Meeting on Subgroup Analyses – Agenda
Subgroup Analyses, Important, Infuriating and Intractable – Rob Hemmings (MHRA)
Biomarker defined subgroups in gastric cancer, a case study – Nigel Baker (AMGEN)
Multiplicity considerations in Confirmatory Subgroup Analysis – Frank Bretz (Novartis)
Genomic Status in Optimizing Subgroup Patient Selection: A case study – Jean-Marie Ledeine (BMS)
Subgroups, clinical sense and statistical challenge – Kit Roes (University Medical Center Utrecht)
Adaptive Clinical Trial Designs for Subgroup Selection – Nigel Stallard (University of Warwick)
Modelling & Simulation and applications to longitudinal data – Programme Agenda
Simplicity, Complexity and Modelling – Stephen Senn – CRP-Santé
The use of modelling and simulation in drug approval – A regulatory view – Norbert Benda – Bfarm
Simulation for Decision Making – MSToolkit for Go/No Go – Chris Campbell – Mango Solutions
Modelling & Simulation and applications to longitudinal data – Programme Agenda
Simplicity, Complexity and Modelling – Stephen Senn – CRP-Santé
The use of modelling and simulation in drug approval – A regulatory view – Norbert Benda – Bfarm
Simulation for Decision Making – MSToolkit for Go/No Go – Chris Campbell – Mango Solutions
Benefit-Risk Assessment Methodology Workshop – Programme Agenda
Quantitative Methods Across the Product Lifecycle – A Personal Perspective – Andrew Thompson -MHRA
Comparison of different Benefit-Risk methodologies – Professor Johan Bring – Statisticon AB
Benefit-Risk Modelling of Pharmaceuticals: Where are we going? – Professor Lawrence Phillips
Benefit-Risk Assessment Methodology Workshop – Programme Agenda
Quantitative Methods Across the Product Lifecycle – A Personal Perspective – Andrew Thompson -MHRA
Comparison of different Benefit-Risk methodologies – Professor Johan Bring – Statisticon AB
Benefit-Risk Modelling of Pharmaceuticals: Where are we going? – Professor Lawrence Phillips
Advances in the Treatment of Missing Data – Prof. Mike Kenward
The Prevention and Treatment of Missing Data: An Author’s Perspective – Prof. Geert Molenberghs
Key Messages from CHMP Guideline and NAS Report on Missing Data – Dr. David Wright (MHRA)
Pattern Mixture Models: An Introduction – Dr. James Roger (GSK)
Implementing Current Regulatory Guidance: An Industry Perspective – Dr. Mouna Akacha (Novartis)
Planning for Missing Data: Case Studies – Dr. Michael O’Kelly (Quintiles)
Evaluating Handling of Missing Data: Case Study in Diabetes – Mark Donovan
Practical Approaches to Minimising Missing Data – Dr. Axel Krebs-Brown (Astellas)
Advances in the Treatment of Missing Data – Prof. Mike Kenward
The Prevention and Treatment of Missing Data: An Author’s Perspective – Prof. Geert Molenberghs
Key Messages from CHMP Guideline and NAS Report on Missing Data – Dr. David Wright (MHRA)
Pattern Mixture Models: An Introduction – Dr. James Roger (GSK)
Implementing Current Regulatory Guidance: An Industry Perspective – Dr. Mouna Akacha (Novartis)
Planning for Missing Data: Case Studies – Dr. Michael O’Kelly (Quintiles)
Evaluating Handling of Missing Data: Case Study in Diabetes – Mark Donovan
Practical Approaches to Minimising Missing Data – Dr. Axel Krebs-Brown (Astellas)
EFSPI-SFdS-B&S Joint European Statistical Meeting : Participant Booklet
EFSPI-SFdS-B&S Joint European Statistical Meeting : 1.1 Véronique Robert
EFSPI-SFdS-B&S Joint European Statistical Meeting : 1.2 Norbert Benda
EFSPI-SFdS-B&S Joint European Statistical Meeting : 1.3 Anne Whitehead
EFSPI-SFdS-B&S Joint European Statistical Meeting : 2.1 Eric Abadie
EFSPI-SFdS-B&S Joint European Statistical Meeting : 2.2 Tomasz Burzykowski
EFSPI-SFdS-B&S Joint European Statistical Meeting : 2.3 Stefan Michiels
EFSPI-SFdS-B&S Joint European Statistical Meeting : 3.0 Maylis Coste
EFSPI-SFdS-B&S Joint European Statistical Meeting : 3.1 Loïc Darchy
EFSPI-SFdS-B&S Joint European Statistical Meeting : 3.2 Andrew Thomson
EFSPI-SFdS-B&S Joint European Statistical Meeting : 4.0 Bernhard Huitfeldt
European Statistical Meeting on Oncology – Agenda
Introduction – Challenges in development in Oncology – H.U. Burger (Hoffmann-La Roche)
A Case Study: Intra-patient Dose Escalation – Jonas Wiedemann (F. Hoffmann-La Roche)
Understanding Progression-free Survival – Bertil Jonsen (Medical Products Agency)
Optimal cost-effective Go-No Go decisions – Cong Chen (Merck & Co)
The time to progression ratio for phase II trials of personalized medicine – Marc Buyse (IDDI)
IRESSA: A journey of experience from broad to biomarker populations – Claire Watkins (AstraZeneca)
European Statistical Meeting on Oncology – Agenda
Introduction – Challenges in development in Oncology – H.U. Burger (Hoffmann-La Roche)
A Case Study: Intra-patient Dose Escalation – Jonas Wiedemann (F. Hoffmann-La Roche)
Understanding Progression-free Survival – Bertil Jonsen (Medical Products Agency)
Optimal cost-effective Go-No Go decisions – Cong Chen (Merck & Co)
The time to progression ratio for phase II trials of personalized medicine – Marc Buyse (IDDI)
IRESSA: A journey of experience from broad to biomarker populations – Claire Watkins (AstraZeneca)
Joint EFSPI-MHRA meeting, London, 29th and 30th March 2010
Statistics at the frontier of drug development
The meeting intended to provide a unique opportunity for discussion amongst industry, regulatory and academic scientists.
If You Are Serious About Benefit:Risk Assessment – Christy Chuang-Stein (Pfizer)
A regulator’s view of end of Phase II decision making and phase II studies – Dr David Wright (MHRA)
Applied Bayesian Approaches in Safety and Pharmacovigilance – Andy Grieve (King‟s College London)
Some recent experiences with novel – Ekkehard Glimm (Novartis)
Modeling for decision making in clinical programs – Rolf Burghaus (Bayer Schering Pharma)
Quantification and evaluation of risk at the time of licensing – Dr David Wright (MHRA)
Meta-analyses of controlled clinical trials for rare AEs – Kevin Carroll (AstraZeneca)
Adaptive designs with subgroup selection in Oncology – Werner Brannath (MUW Vienna)
Joint EFSPI-MHRA meeting, London, 29th and 30th March 2010
Statistics at the frontier of drug development
The meeting intended to provide a unique opportunity for discussion amongst industry, regulatory and academic scientists.
Finding independence graphs for clinical trial adverse event data – Joe Whittaker and Lucy Bradshaw (Lancaster University) Harry Southworth (AstraZeneca)
If You Are Serious About Benefit:Risk Assessment – Christy Chuang-Stein (Pfizer)
A regulator’s view of end of Phase II decision making and phase II studies – Dr David Wright (MHRA)
Applied Bayesian Approaches in Safety and Pharmacovigilance – Andy Grieve (King‟s College London)
Promoting high-quality and informative exploratory development: obstacles and aids – Michael O’Kelly (Quintiles)
Quantitative benefit-risk assessment: An analytical framework for a shared understanding of the effects of medicines – Mike Colopy & Patrick Ryan (GSK)
Some recent experiences with novel – Ekkehard Glimm (Novartis)
Modelling for decision making in clinical programs – Rolf Burghaus (Bayer Schering Pharma)
Quantification and evaluation of risk at the time of licensing – Dr David Wright (MHRA)
Meta-analyses of controlled clinical trials for rare AEs – Kevin Carroll (AstraZeneca)
Adaptive designs with subgroup selection in Oncology – Werner Brannath (MUW Vienna)
EFSPI-SFdS-B&S Joint European Statistical Meeting : Participant Booklet
EFSPI-SFdS-B&S Joint European Statistical Meeting : 1.1 Véronique Robert
EFSPI-SFdS-B&S Joint European Statistical Meeting : 1.2 Norbert Benda
EFSPI-SFdS-B&S Joint European Statistical Meeting : 1.3 Anne Whitehead
EFSPI-SFdS-B&S Joint European Statistical Meeting : 2.1 Eric Abadie
EFSPI-SFdS-B&S Joint European Statistical Meeting : 2.2 Tomasz Burzykowski
EFSPI-SFdS-B&S Joint European Statistical Meeting : 2.3 Stefan Michiels
EFSPI-SFdS-B&S Joint European Statistical Meeting : 3.0 Maylis Coste
EFSPI-SFdS-B&S Joint European Statistical Meeting : 3.1 Loïc Darchy
EFSPI-SFdS-B&S Joint European Statistical Meeting : 3.2 Andrew Thomson
EFSPI-SFdS-B&S Joint European Statistical Meeting : 4.0 Bernhard Huitfeldt
26th June 2009
Basel, Switzerland
This meeting was a joint venture between EFSPI and BBS.
The Basel Biometric Section (BBS) in cooperation with the European Federation of Statisticians in the Pharmaceutical Industry (EFSPI) held a one day European Statistical Meeting on Meta Analysis.
Speakers from industry, academia and regulatory shared their views on Meta – Analysis.
1 – Steven Julious (University of Sheffield) Interpreting Treatment effects from a Number of Trials with Application to Designing Future Trials Download pdf file
2 – Anne Whitehead (University of Lancaster) Sequential methods for Random Effects Meta-Analysis Download pdf file
3 – Tomasz Burzykowski (IDDI Belgium) Meta-Analysis and Validation of Surrogate Endpoints Download pdf file
4 – Steffen Witte et al. (Novartis Basel) Meta-Analysis to Compare Combination Therapies A Case Study in Kidney Transplantation Download pdf file
5 – Beat Neuenschwander et al. (Novartis Basel) Subgroup Analysis using Bayesian Hierarchical Models: A Case Study Download pdf file
6 – Sally Hollis (Astra Zeneca, UK) Work of the Cochrane Collaboration Cochrane collaboration: Systematic Reviews of the Effects of Healthcare Interventions Download pdf file
7 – Guido Schwarzer (University of Freiburg) Meta-Analysis on Erythropoiesis-Stimulating Agents Download pdf file
Panel Discussion: Meta-Analyses and Implication for the Industry
Stephen Senn (University of Glasgow), David Wright (MHRA)
Thursday 20th November 2008
Verona, Italy
This meeting was a joint venture between EFSPI, BIAS, and SSFA.
Non-inferiority trials have been around for many years, but are still controversial. Experts from industry, academia and regulatory bodies have presented and discussed a range of issues concerning these trials.
One hundred participants have attended this very fruitful meeting
Brussels, May 18th-21st, 2008 | This was a European Conference aimed at Statisticians in the Pharmaceutical Industry. Many opinion leaders from industry, academia and regulatory have spoken.
On June 15th, 2007, EFSPI and BBS hold a Scientific One-day Meeting on Adaptive Designs in Drug Development
Opinion leaders from industry, academia and regulatory shared their views on Flexible/Adaptive Designs, via presentations and discussion.
Members of the audience were able to question the opinion leaders during panel discussion. This controversial subject generated an interesting debate.
Slides presented during the meeting are available below:
1 – Andy Grieve (King’s College, London) Adaptive Designs : An Overview Download pdf file
2 – Werner Brannath (Medical University of Vienna) : Estimation in Flexible Adaptive Design Download pdf file
3 – Alun Bedding (Glaxo SmithKline) : Learning as we go: the use of Bayesian Methodology for Adaptive Designs Download pdf file
4 – Gernot Wassmer (Köln University) : Adaptive Treatment Selection with Survival Endpoints Download pdf file
5 – Fiona Guillard (Glaxo SmithKline) : Case study for a continually adapting design Download pdf file
6 – Mike K Smith (PGRD, Sandwich, UK) : Case studies of Bayesian adaptive designs using various amounts of prior information Download pdf file
7 – David Lawrence (Novartis) : Phase II/III Adaptive Design with Treatment Selection: A case study Download pdf file
8 – Rob Hemmings (MHRA, UK) : Adaptive Designs – Latest thinking from this regulator! Download pdf file
On December 7th, 2006, EFSPI hold a Scientific One-day Meeting on Adaptive Randomisation – Today and Tomorrow |
Morning: Adaptive Randomisation – A Personal and Collective Perspective
|
On December 7th, 2006, EFSPI hold a Scientific One-day Meeting on Adaptive Randomisation – Today and Tomorrow Opinion leaders from industry, academia and regulatory shared their views on Adaptive Randomisation, in particular focusing on covariate balancing, via presentations and a panel discussion. A number of case studies and papers have also been presented in the afternoon session. Slides presented during the meeting are available below: |
Morning: Adaptive Randomisation – A Personal and Collective Perspective
|
EFSPI Secretariat
St James House
Vicar Lane
Sheffield
S1 2EX
Tel: +44(0)1625 664549
Email: admin@efspi.org
