• PSI Toxicology SIG Workshop 2018

    Stockley Road | Dates: 24 – 25 Apr, 2018

    The Toxicology SIG provides a forum for statisticians working in regulatory and investigative toxicology to discuss issues and interact with one another. 

    This 1.5-day workshop will involve hopefully approximately 20 statisticians, focusing on discussions around “best practice” in the statistical analysis of various data types. 

    The cost will be £225 including VAT per delegate, inclusive of food and one night’s accommodation.  The workshop is being held at the Crowne Plaza Hotel, Heathrow. 

    The agenda and topics that will be discussed is yet to be finalised, but please get in touch with gareth.thomas@envigo.com if you have suggestions.  Full details will be circulated in the coming months.

    Registration Costs
     £225 incl VAT Inclusive of food and one night’s accommodation 


    Please click here to register.

  • Health Technology Assessment (HTA)

    Gothenburg | Dates: 24 – 25 Apr, 2018
    This 2-day course will provide an introduction to the methods of health technology assessment.  There will be a focus on how to estimate the costs and benefits of new interventions and analysis undertaken to support decisions about whether new interventions should be funded by health systems.  The first day will include sessions on policy context and basic economic evaluation methods, as well as lectures on health measurement and valuation for HTA, evidence synthesis and decision analysis.  There will also be exercises to confirm participants’ understanding of key concepts. The second day will focus on sharing case studies and discussing key statistical challenges in HTA such as treatment switching, extrapolation, and network meta-analysis.  Attendees will be encouraged to share their own HTA experiences.  

    Please click here to view the flyer.

    The following topics will be covered:

    • HTA Policy
    • Methods of Economic Evaluation
    • Critical Review of HTA Publications
    • Evidence Synthesis
    • Measuring and Valuing Health
    • HTA Decision Models
    • Industry HTA Case Studies
    • Key Statistical Challenges in HTA

    Presenters:

    • Mark Sculpher, Professor of Health Economics and Director of the Programme on Economic Evaluation and Health Technology Assessment at the University of York.
    • Neil Hawkins, Professor of Health Economics and Health Technology Assessment at the University of Glasgow.
    • Jan McKendrick, Senior Director at PRMA Consulting Ltd.
    • Anja Schiel, Senior Advisor and Statistician and the Norwegian Medicines Agency (NoMA)
    • Jonathan Alsop, Director at Numerus.

    Course runs from:

    Day 1: 09:00 – 17:30 (registration from 8:30)  
    Day 2: 09:00 – 15:30 

    Registration:

     Registration has now closed.

    PSI are holding a limited number of reduced price hotel rooms at Gothia Towers until the 23rd March which will be allocated on a first come first served basis.

    Registration costs (includes lunch and refreshments)

     Before 23rd March
     PSI Members £495
     Non-Members £590
     After 23rd March
     PSI Members £595
     Non-Members £690

    PSI are holding a limited number of hotel rooms at Gothia Towers on 23rd and 24th April which will be allocated on a first come first served basis. Rooms will be charged at £115 per room per night including breakfast. Please contact psi@mci-group.com to make a reservation.
  • PSI Journal Club Webinar: Modelling and Simulation

    Dates: 26 – 26 Apr, 2018

    Time: 14:00 - 15:30 UK Time 

    Our next journal club features two papers on the topic of Modelling and Simulation.  Please join us to hear Michael O’Kelly (IQVIA) and Carl-Fredrik Burman (Astrazeneca) present their recent work:

    The Chair will be Vladimir Anisimov (Amgen).

    The event will be held on Thursday 26th April, 2:00-3:30pm (UK time), just block out the date and time in your calendar.  

    Dial-in details

    In preparation and prior to the day of the webinar, please find below the link you will need to follow in order to obtain your personal dial in details and register with the webinar software. After registering via this link, you will receive a confirmation email containing information about joining the webinar, including details on how to dial-in via the telephone.

    Please ensure you allow enough time before joining to download the correct software.

    https://register.gotowebinar.com/register/7612071121697734659

     

    Please click here to view the flyer

  • RSS Webinar - Missing Data in Clinical Trials: Making the Best of What We Haven’t Got

    Dates: 08 – 08 May, 2018

    Speaker: Michael O’Kelly (Principal Scientific Advisor, IQVIA)

    Researchers in the last twenty years have come up with a snowstorm of ideas about how to interpret the results of clinical trials that have missing data. Michael O’Kelly summarises the landscape of ideas as he and his colleagues found it. A key change was the move from trying to “handle” missing data, to realising that missing data should be included in our understanding of clinical trial results. We can try to include missing data in our results by coarsening the outcome so as to include the missingness itself as part of that outcome; or by qualifying any estimate of treatment effect with sensitivity analyses; or by modelling some kind of counterfactual so as to attempt causal inference on a stratum of interest such as subjects who would have had no missing data. There are strong objections to each of these options, and the arguments continue. Michael will describe how in his own company, IQVIA, local Missing Data Superusers have improved the understanding of the issue of missing data, and also notes the strong co-operation in industry and academia in sharing methodologies for missing data. Current publicly available resources for statisticians will be summarised. Finally, Michael will talk about three key points: preventing missing data in clinical trials; how evidence from previous clinical trials can help give confidence in results when there is missing data; and the importance of clinical interpretability of results from trials with missing data.

    Please click here for the dial-in details.

  • PSI Webinar: Patient Reported Outcomes (PROs) - Clinically Meaningful Interpretation

    Dates: 08 – 08 May, 2018
    Time: 14:00 - 15:30 UK Time
    Presenters: Kim Cocks (Adelphi Values), Andrew Thompson (EMA) and Christoph Gerlinger (Bayer)

    Clinical Trials are increasingly featuring a wide variety of Patient Reported Outcomes (PROs).  PROs are important endpoints to both regulatory and health technology bodies in their assessments and approvals. There are standard ways in which PRO instruments are developed and validated, as well as important concepts for designing and interpretation of PRO data in clinical trials such as assessing the Minimally Clinically Important Differences (MCIDs/MIDs) and the use of a Responder definition.

    The intent of this webinar is to describe an overview of how PROs tools are developed and used in clinical trial settings and how results can be clinically and meaningfully interpreted. In addition, a regulatory viewpoint will be shared on the key considerations for PROs. The talks will also include examples and case-studies showing the derivation of a validated thresholds for treatment responder and interpretation of PROs in the context of regulatory approval.

    Click here to view the flyer. 

    Click here to register.

    Kim Cocks (Adelphi Values)

    kim cocksKim Cocks is a Director and Principal Statistician at Adelphi Values, a global healthcare consultancy. She has worked as a medical statistician and clinical trial methodologist for over 20 years across pharmaceutical, academic and consultancy environments. She specialises in PRO interpretation and analysis and is an active member of both the EORTC Quality of Life group and ISOQOL.





    Abstract
    Overview of PROs and clinically meaningful interpretation

    PROs are validated instruments designed to provide a direct report from the patient on aspects of their health including symptoms and functioning. This talk will provide a brief overview of how PROs are developed, how they provide a score for multi-dimensional aspects of a patient’s health and why these can be difficult to interpret. The variety of quantitative and qualitative methods available to aid interpretation will be introduced.  


    Andrew Thomson (EMA)

    andrew thomsonAndrew Thomson is a statistician at the EMA, in the Human Medicines Research & Development Support  Division. Prior to joining the EMA in 2014, he spent 7 years at the MHRA, initially as a Statistical Assessor in the Licensing Division, and subsequently Head of Epidemiology in the Vigilance & Risk Management of Medicines Division.








    Abstract
    Regulatory Considerations for PROs
    In this talk I will present some regulatory considerations on the use of PROs in regulatory assessment, and how they can be developed. These will be discussed alongside a recent case example that has been through the qualification procedure at EMA.


    Christoph Gerlinger (Bayer)

    christoph geringerChristoph Gerlinger is Bayer’s Expert Statistician for Health Technology Assessment and Women’s Health. He is the regulatory chair of the European Federation of Statisticians in the Pharmaceutical Industry (EFSPI) and a work package leader for the IMI BigData@Heart project. Christoph worked as statistician over 25 years in the pharmaceutical industry and in his spare time he teaches at the University Medical School of Saarland.








    Abstract
    Empirical derivation of the minimal important difference for PROs
    In this talk I will present some methods on how to derive the minimal important difference for PROs from a clinical trial. I will present a worked example where we used this empirical minimal important difference to formulate a responder definition that was then accepted by the FDA.


    Click here to register.

     Registration
     PSI Member Free 
     Non-member £20 (plus VAT)  


  • PSI Training Course: Multiple Testing in Confirmatory Clinical Trials

    Dates: 09 May, 2018

    To be presented by Carl-Fredrik Burman & Lisa Hampson

    Regulatory agencies require strong control of the Type I Error for all confirmatory statistical tests. Multiplicity issues can arise for several reasons, e.g.: the possibility of winning on two different endpoints (like PFS and OS), interim analyses, or testing for effects in several patient groups. This course will focus on the principles underlying multiple comparison procedures and their applications to confirmatory clinical trials. We will describe simple ways to construct valid multiple tests, and will explore how tests can be incorporated into recycling strategies. Group-sequential and some common adaptive tests will also be described. Concepts will be introduced through a combination of lectures, exercises, and discussion sessions where groups will focus on the issues that might be encountered when designing and communicating statistical tests.

    The following topics will be covered:

    • Introduction to Multiple Testing
    • Recycling and graphical methods
    • Group sequential and adaptive designs
    • Operating characteristics and improving them using correlations
    • Using decision analysis to optimise multiple testing procedures

    Registration

      Early bird (up to & including 9th April)  After 9th April
    PSI Member  £295 + VAT  £345 + VAT
    Non-Member  £390 + VAT  £440 + VAT

    Please click here to register.

    Registration costs include lunch and refreshments. PSI are holding a limited number of hotel rooms on 8th May which will be allocated on a first come first served basis. Please contact psi@mci-group.com to reserve a room. Rooms are charged at £109.00 per room including breakfast.
  • Statistics Fundamentals of Clinical Trials for Non-Statisticians (or ‘How to speak stats in a day!’)

    Reading | Dates: 10 – 10 Jul, 2018

    This basic but wide-ranging course covers techniques for investigating, visualising and performing basic statistical techniques on data sets typical to industry settings. There are many basic concepts that need to be understood before statistics can be used to its full potential to give useful and informative answers. This course ensures that these concepts are understood in a non-technical way and then demonstrated using data examples.

    Mathematical details are kept to a necessary minimum and we focus on the interpretation of statistical output and illustrate applications with data from dummy clinical trials or published data. The objective of the course is not to teach you how to become a statistician, but to help you work with statisticians and get the maximum value from statistical output.

    The course will consist of lectures, practical examples and discussions. There will not be any computer exercises.

    Target Audience:

    This is a 1-day course, aimed to introduce statistics to people who work on Clinical Trials, but who are not Statisticians. No previous knowledge of Statistics is assumed as we start right at the beginning with the basics. Many practical examples are given and the emphasis is on application and understanding rather than the equations and the technical background.

    The basics of statistics are discussed to give background and a common base to start from and the applications and use of statistics in drug development is then discussed. The role of the statistician and their ability to help with decision making is also discussed.

    It also serves as a useful refresher course to those who once studied statistics as part of a college course.

    The following key topics will be addressed:

    1.  Types of Data
    2.  Measures of Location and Variability
    3.  Basic Inference
    4.  Power Calculations and Sample Sizing
    5.  Design Issues

    For more information on specific topics, please contact the presenter direct on gemma@qistatistics.co.uk

    About the Presenter: 

    Gemma Hodgson, Qi Statistics Ltd. http://www.qistatistics.co.uk

    Gemma Hodgson has worked in the Pharmaceutical industry for over 20 years. After receiving her first degree from Imperial College (Maths with Statistics) and then an MSc in Medical Statistics from London School of Tropical Hygiene and Medicine, Gemma began her career at Pfizer in Sandwich working in experienced global teams on major phase 3 projects. After 13 years at Pfizer and working in all phases of development, from phase 1 to phase 4, Gemma then moved to Takeda R &D in London where she worked on later phase projects, focussing on close liaison with other departments within the organisation. In 2012 Gemma left Takeda to work for a statistical training and consultancy firm, Qi Statistics Ltd, where training of non-statisticians and explaining statistical concepts to non-scientific audiences is key. Gemma has a broad interest in the application of statistics and is an experienced trainer to all types of audience, specialising in translating technical concepts into everyday English.

    Registration:

    Course runs from: 09:30 – 16:30 (registration/coffee from 9:00)

    Please register online at www.psiweb.org and click on Events; payment now available online. Registration costs (includes lunch and refreshments).

     Registration on or before 8th June 2018

    Registration after 8th June 2018

     £425 + VAT  £495 + VAT

    Please click here to register.

    PSI aims to be fully inclusive and endeavours to accommodate delegates with disabilities wherever possible.  Please help us to help you by letting us know if you require additional facilities or have any special requirements.  Please contact us on +44 (0)1730715235 or at psi@mci-group.com for further information.

  • PSI One Day Meeting and Workshop: Real World Evidence: Generalisability of Treatment Comparisons for Decision Making

    61352 Bad Homburg | Dates: 18 – 18 Sep, 2018

    RWE data are an increasingly valuable resource in drug development. One area where this data is being used regularly is in the generalisability of treatment comparisons. This event will focus on this topic and more specifically on the following three areas:

    • New advances in indirect comparisons
    • Generalizability approaches for clinical trial data into the real world setting
    • Cross-design approaches combining observational and randomized data

    The aims of the event are to:

    • share what research approaches are currently discussed
    • get feedback and inspiration from related fields and researchers
    • ·obtain feedback and insights from members of HTA bodies
    • raise awareness and education on generalisability methods

    in a very interactive way. The agenda is specifically designed to maximize interaction between participants in a structured way. As such, active participation in the discussions is appreciated. Please note that there is a maximum number of participants (60) for this event due to the interactive nature.

    In the morning there will be presentations by industry and academic speakers. The afternoon will consist of parallel interactive workshop sessions where there will be the opportunity for participants to expand on the topics discussed in the morning, to learn from each other, share examples and experiences. The event concludes with a panel discussion bringing the learnings from the break out discussions back to the overall audience.

    Agenda

    08:30 - 08:50  Registration
    08:50 - 09:00 Welcome and Introduction
    Alexander Schacht (Lilly)
    09:00 - 10:00          Indirect comparisons with and without adjustment for patient characteristics and related approaches
    Sarah Böhme (Pfizer)
    David Phillippo (University Bristol)
    10:00 - 11:00 Generalizability of clinical trial data into real life settings
    Yann Ruffieux (University Bern)

    Alan Brnabic (Lilly)

    11:00 - 11:15 Break
    11:15 - 12:15 Cross-design approaches combining observational and clinical trial data 
    Mark Belger (Lilly)

    Keith Abrams (University Leicester)

    12:15 - 13:15 Lunch
    13:15 - 14:45  

    Break out #1: Bucher vs matching adjusted indirect comparisons and further refinements of these

    Break out #2: Generalizability of clinical trial data into real life settings

    Break out #3: Cross-design approaches combining observational and clinical trial data

    14:45 - 15:00 Break
    15:00 - 16:00  

    Panel discussion

    Alexander Schacht (Lilly, moderator)
    Carsten Schwenke (SCOSSIS)
    Ralf Bender (IQWiG)
    Nicky Welton (University Bristol)
    Keith Abrams (University Leicester)
    Chrissie Fletcher (Amgen)
    Mark Belger (Lilly)

    16:00 Close 

     
    Registration
    PSI Member £40
    Non-Member £135 (This includes free PSI membership for the remainder of 2018)

    Please click here to register.

    A limited number of hotel rooms have been reserved at the Maritim Hotel Bad Homburg (Ludwigstraße 3, 61348 Bad Homburg vor der Höhe). These will be allocated on a first come first served basis. If you would like to reserve a room for the night of 17th September please contact psi@mci-group.com. Rates are €136 per room including breakfast.

    There will also be a dinner at Restaurant am Römerbrunnen (Kisseleffstraße 27, 61348 Bad Homburg vor der Höhe) on the evening prior to the meeting which attendees are invited to (at their own expense). Please indicate when registering if you would like to attend the dinner and you will contacted by the local organisers with additional details.


  • Introduction To Industry Training Course 2018

    Dates: 01 Oct, 2018 – 01 Nov, 2019

    Are you a PSI member with approx. 1-3 years experience as a Statistician or a Statistical Programmer within the industry?


    THE INTRODUCTION TO INDUSTRY TRAINING COURSE NEEDS YOU!

     PLEASE CLICK HERE TO VIEW THE FLYER

    NEXT COURSE STARTS OCTOBER 2018
    PSI Member: £1050 + VAT
    Non-Member: £1145 + VAT

    AIM: To describe the drug development process from research right through to research, toxicology, data management & role of the CRO, clinical trials, product development & manufacture and marketing.

    Limited places available!

    Application forms must be received by 30th June 2018!

    Please discuss your application with your manager
    Final dates to be confirmed.

    CLICK HERE TO DOWNLOAD THE APPLICATION FORM

    For further information contact:

    Alex Godwood & Zelie Bailes

    Heptares Therapeutics Ltd
    Bio-Park
    Broadwater Road
    WELWYN GARDEN CITY, Hertfordshire AL7 3AX

    Tel: 01707 448020   

     

    Email: alex.godwood@heptares.com
    zelie.a.bailes@gsk.com