• Estimating Sample Sizes in Clinical Trials

    Dates: 28 – 29 Jun, 2017

    How to find us: Novotel, London Excel, UK

    Presented by Steven A. Julious
    Steven is a Professor of Medical Statistics at The University of Sheffield but through his career has worked in both the academic and pharmaceutical sector and is a former editor of the journal Pharmaceutical Statistics.  He has an interest in applied methods for clinical trials and has a particular interest in clinical study design and sample size estimation.  He has written two books one on early phase trials and one on sample size estimation and has also developed an App called SampSize for the estimation of sample sizes.

    About the course:
    The three most important aspects of a clinical trial are: design, design and design.  A sample size estimate is just one aspect of a clinical study design. 

    The course describes calculations for sample size estimation in the design of clinical trials. It will be highlighted how the objectives of a clinical trial will impact on sample size calculations. The course is a practical course and all methods will be illustrated with examples and case studies.


    The following topics will be covered:

    Introduction to Key Concepts
    - Type I error
    - Type II error
    - Power

    Sample Sizes for Different Clinical Trial Objectives
    - Superiority
    - Equivalence
    - Non-inferiority
    - Precision based
    - Bioequivalence
    - Pilot studies

    Sample Sizes for Different Types of Data
    - Normal
    - Binary
    - Ordinal
    - Survival

    Clinical Trial Designs
    - Cross-over
    - Parallel Group

    How Design Considerations Impact on the Sample Size
    - Baselines/covariates
    - Multiple endpoints

    Other Considerations when Designing a Trial
    - Sensitivity analysis
    - Optimising variance estimates

    Considerations which Impact on the Sample Size
    - Adaptive designs for efficacy
    - Assessing futility
    - Sample size-re-estimation

    Course runs from:
    10:00 – 17:30 (registration from 9:30) on Day 1
    09:00 – 16:30 on Day 2.

    Registration costs (includes lunch and refreshments)

    Before 30th May 2017

    PSI Members

    £495 + VAT

    Non-Members

    £570 + VAT (includes PSI membership for 1 year)

     

    After 30th May 2017

    PSI Members

    £595 + VAT

    Non-Members

    £670 + VAT (includes PSI membership for 1 year)

     

    PSI are holding a limited number of hotel rooms at an extra cost until the 30th May 2017 which will be allocated on a first come first served basis.  Please contact the PSI Secretariat for more information.

    ​Registration for this course has now closed.

  • YSS Statistical Showcase 2017

    Dates: 30 Jun, 2017

    A member of PSI CALC will be attending and presenting at this year’s YSS Statistical Showcase to be held on Friday 30th June near to the RSS headquarters in Erroll Street, London (venue tbc due to planned building work). It will feature a morning training session, followed by an afternoon of talks from statisticians based in a diverse range of fields, including government, academia and medicine. There will also be two special keynote addresses from our distinguished speakers Professor Jane Hutton and Professor David Hand. The event will close with a wine reception for networking and further discussion. The event is aimed at young statisticians and registration is now open. 

    CLICK HERE TO REGISTER

  • Patient Preferences in Benefit-Risk Assessments during the Drug Life Cycle: PREFER – an IMI Project

    Dates: 12 – 12 Jul, 2017

    By Conny Berlin

    In our 1-hour webinar on the 12 of July 2017 (4:30pm CET, 3:30pm BST, 10:30am EST) we will have a presentation by Conny Berlin who is the industry project leader of the public-private IMI PREFER project.

    Click here* to register for the webinar.

    *PSI Non-Members can register by clicking on the 'Create an Account' link on the right hand side of the landing page.

    Abstract

    The main objective of the IMI PREFER project is to strengthen patient-centric decision making throughout the life cycle of medicinal products by developing evidence-based recommendations to guide industry, Regulatory Authorities, HTA bodies, reimbursement agencies, academia, and health care professionals on how and when patient-preference studies should be performed and the results used to support and inform decision making.

    While over the last years all stakeholders gained experience individually how to engage patients for decision making this project aims to bring all stakeholders together taking a structured approach to determine their needs, expectations, and concerns regarding the use of patient-preference information and methodologies for patient-preference elicitation. 

    Methodologies for patient value elicitation are available and have been used frequently in market research, in health economics and outcomes research to substantiate real-life evidence. Further structured research has been done in projects like IMI PROTECT but there is no systematic use of these methodologies in the regulatory licensing processes yet. 

    The presentation will address 

    • Objective of PREFER
    • Changing environment
    • Patient preference study example
    • PREFER participants
    • PREFER project approach & status

    About the Presenter

    Conny Berlin, Global Head Quantitative Safety & Epidemiology, 
    Novartis International AG
     


    Conny Berlin

    Conny Berlin leads the Quantitative Safety & Epidemiology group at Novartis International AG. She holds a degree in mathematics from the University of Rostock, Germany and has more than 25 years of experience within the pharmaceutical industry.

    Conny Berlin has a profound knowledge of quantitative methodology as applied to clinical and observational data and to spontaneous reports to respond to safety and benefit-risk questions during drug development and post-approval.

    Conny Berlin is a member of the company’s internal Medical Safety Review Board and of the Real World Evidence Leadership Team.

    She is well experienced in managing projects, leading and coordinating interdisciplinary teams. Conny Berlin is the industry project leader of the public-private IMI PREFER project.

     Relevant references 

    • Esther W. de Bekker-Grob, Conny Berlin et al. Giving Patients’ Preferences a Voice in Medical Treatment Life Cycle: The PREFER Public–Private Project. Patient: Editorial
    • Participant of the CIOMS working group X on "Evidence Synthesis and Meta-Analysis for Drug Safety"; report published in 2016
    • Berlin C, Blanch C et al. Are all quantitative postmarketing signal detection methods equal? Performance characteristics of logistic regression and Multi-item Gamma Poisson Shrinker. Pharmacoepidemiology and Drug Safety. 2011: 622-630

     

     

  • PSI Webinar: IMI PREFER - Patient preferences: why, how and when

    Dates: 21 Sep, 2017
    Join us for a PSI Webinar on IMI PREFER - Patient preferences: why, how and when on Thursday 21st September at 11:00 EST / 15:00 GMT. Presented by the EFSPI/PSI special interest group on benefit-risk.

    Please see below for details of the speaker:

    Bennett Levitan

     



    Bennett Levitan_2013- smaller file-
     


    Bennett Levitan, MD-PhD is Senior Director, Benefit-risk Assessment, Department of Epidemiology at Janssen R&D, Pharmaceutical Companies of Johnson & Johnson.  He introduced state of the art patient-focused benefit-risk assessment to Janssen and has led numerous teams in preparation of benefit-risk assessments for regulatory submissions and health authority advisory meetings.  He has co-led cross-disciplinary teams to implement processes to support growing regulatory requirements for patient-focused benefit-risk assessment both during development and post-approval.  Bennett has published widely on both theoretical and pragmatic aspects in benefit-risk and patient preference studies and is a frequent speaker on these topics in national and international conferences.  He co-led development of the PhRMA Benefit Risk Action Team (BRAT) Framework for drug benefit-risk assessment, which has become a foundational piece of work in the field.  Bennett serves on several committees that inform policy on benefit-risk methods including the IMI PREFER project on patient preference assessment and use, the Medical Device Innovation Consortium (MDIC) Patient Centered Benefit-Risk Project, the ISPE Benefit Risk Assessment, Communication and Evaluation (BRACE) team, the CTTI Patient Groups & Clinical Trials work stream and the PCORI Advisory Panel on Patient Engagement.  Bennett received his B.Sc. (Electrical Engineering) from Columbia University in New York and his M.D.-Ph.D. (Bioengineering) from the University of Pennsylvania and was a postdoctoral fellow at the Santa Fe Institute.
     

     


    The webinar is free to attend but you must register your place in advance. Please click here to register.

    For more information please visit: 
    https://www.benefit-risk-assessment.com/imi-prefer-patient-preferences-why-how-and-when/
  • Improving Influence and Increasing Impact: Essential Skills for Industry Statisticians

    Slough | Dates: 21 – 21 Sep, 2017

    Presented by

          Andy Grieve, Gemma Hodgson, Margaret Jones (& external speaker tbc)

     
    The landscape is changing across the pharma industry and as statisticians, in order to continually add value, we must make sure we adapt. This course will focus on what this means for statisticians outside the technical aspects of their role. Of critical importance is self-awareness during our interactions, working effectively in teams, influencing, being customer focussed and understanding our own consulting and leadership styles.

    Now more than ever we need to be creative and influential thinkers with business acumen who can work with our colleagues from other disciplines, not just be technical experts - we need to be proactive partners with strong communication skills.

    This course will lead participants, in a non-threatening and encouraging atmosphere, through the process of understanding their own strengths and weaknesses and what this means when working as a strategic partner or as part of a larger team. It will include workshops to practice the skills and behaviours discussed.

    This course is aimed at statisticians who want to improve their consultancy style interactions within their internal project teams and/or with external customers and understand the impact of their own behaviours and interaction preferences.

    The following topics will be covered:
    • Myer-Briggs profiling and interactions preferences
    • Effective Team working
    • What does it mean to be a consultant?
    • Questioning styles
    • Effective Communication Skills
    • Owning your own development

    Course runs from: 10:00 - 17:00 (registration from 09:30)

    Registration

    CLICK HERE TO REGISTER

    Registration Costs (includes lunch and refreshments):

    PSI Members £345 + VAT
    Non-members £425 + VAT (includes PSI membership for 1 year)

    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)845 180349 or at PSI@mci-group.com for further information.
  • Introduction To Industry Training Course 2017

    Dates: 01 Oct, 2017 – 31 Jul, 2018

    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 2017: £1050+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 2017!

    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

    MedImmune Ltd, Milstein Building, Granta Park

    Great Abington, Cambridge, CB21 6GH

    Tel: 0203 7496241

    Email: godwooda@MedImmune.com