• PSI Webinar: Adaptive design: updated draft FDA guidance and its implications

    Dates: 04 – 04 Jul, 2019

    14.00-15.30 UK Time

    In September 2018 the FDA published a guidance on adaptive design for clinical trials of drugs and biologics, updating (not finalizing) its initial draft from February 2010.  The main focus of the webinar will be to provide an overview of its main contents, which will be presented by Jürgen Hummel (PPD). In addition, Kaspar Rufibach (Roche) will introduce an open-source statistical software for adaptive designs, RPACT (an R package that enables the design and analysis of confirmatory adaptive clinical trials).  Kit Roes will also comment on the guidance from a European Regulatory perspective, which will be followed by a brief panel discussion.


    This Webinar is free to attend, to register please click here.

     Photo Jurgen Hummel (2019)
    Jürgen Hummel joined PPD near Glasgow (Scotland) in 2006, where he is Senior Director, Statistical Science. He heads up the statistical science track within PPD Biostatistics and provides statistical consultancy both internally and externally. Specifically, he has been leading PPD’s cross-departmental Adaptive Design Working Group since it was set up 8 year ago.  In his career he held a variety of technical and managerial positions within the biostatistics department of different organizations, predominantly within the CRO industry.  Jürgen earned a Diplom (German equivalent of a master’s degree) in mathematics and economics at Augsburg University, Germany, and has been a chartered statistician with the Royal Statistical Society since 2006.          

     Photo Kaspar Rufibach
    Kaspar Rufibach is a member of Roche's Methods, Collaboration, and Outreach group and located in Basel. He does methodological research, provides consulting to Roche statisticians and broader project teams, gives biostatistics trainings for statisticians and non-statisticians in- and externally, mentors students, and interacts with external partners in industry and the academic community in various working groups. He has co-founded and co-leads the Oncology estimand Working group that currently has 31 members from 19 companies and works on various topics around estimands in oncology. Research interests are methods to optimize study designs, advanced survival analysis, probability of success, estimands, estimation of treatment effects in subgroups, and general nonparametric statistics. Before joining Roche, Kaspar received training and worked as a statistician at the Universities of Bern, Stanford, and Zurich.

    Kit Roes is Professor of Clinical Trial Methodology at the Julius Center of the University Medical Center Utrecht. His research focus is on design and analysis of clinical trials, with an emphasis of innovative designs, rare diseases and bridging the gap between clinical trials and real world evidence. He participates in the Regulatory Science Network Netherlands, is chair of Methodology at the Dutch Medicine Evaluation Board and member of the Biostatistics Working Party of the EMA. He serves on multiple Data and Safety Monitoring Boards. His experience includes over 20 years in clinical research and development in the pharmaceutical industry and academic life sciences, serving clinical research and drug development as expert as well as in different (international) senior management positions.

  • The RSS & PSI’s Journal Club: Survival Analysis

    Dates: 11 – 11 Jul, 2019
    Time: 16:00 - 17:30 (UK Time)

    Please click PSI RSS journal club July 2019 to view the flyer.

    REGISTER HERE: https://attendee.gotowebinar.com/register/1637867005156132108

    Join us in our discussion on survival analysis method with focus on the application of two Bayesian methods for time to event data at 4pm (BST) on Thursday 11 July.

    Our two presenters are Peter Thall from MD Anderson and Kyu Ha Lee from Harvard. The discussants are: Axel Gandy, Imperial College London (RSS discussant) and Neby Bekele, Gilead Sciences (PSI discussant).

    The webinar is sponsored by Wiley who will make both papers free to access for a few weeks before and after the webinar.

    In preparation and prior to the day of the webinar, please follow the link above 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 allow enough time before joining to download the correct software.

    Audio recordings will be available shortly after the JC to download from the PSI website. The meetings are open to everyone regardless to whether you are a member of PSI or RSS.  

    For further info/feedback, or to submit a question to the authors in advance of the meeting please contact journalclub@psiweb.org

  • PSI One day Scientific meeting: The analysis and reporting of PROs in Clinical Trials

    Dates: 17 – 17 Jul, 2019


    Patient reported outcomes have become increasingly important in the development, approval and reimbursement of our products. The PSI Scientific Committee have put together this one day meeting to provide statisticians with introductions to PROs, how to include them in clinical trials, considerations about missing data, appropriate statistical methods to analyse and interpret the data and the perspective of an IQWiG assessor. Presenters will give their insight into discussions with colleagues, working groups and regulators and there will be plenty of opportunity to ask any questions you may have about PROs in your development program.

    Time   Topic
     9:00 – 9:30 Registration
      9:30 – 9:45  Welcome and Introduction to PSI and ISOQoL
     9:45 – 10:30 Introduction to Patient Reported Outcome (PRO) Measurement

    Tara Symonds (Clinical Outcome Solutions)

     10:30 – 10:45      Break
     10:45 – 11:30 Improving the design and reporting of PRO trial data: implementation of the SPIRIT-PRO and CONSORT-PRO Extensions

    Melanie Calvert (Birmingham University)

     11:30 – 12:15 TBC

    Ingolf Griebsch (Boehringer-Ingelheim)

     12:15 – 13:15 Lunch
     13:15 – 14:00 Analysis of PRO data: SISAQOL recommendations and practical examples

    Kim Cocks (Adelphi Values)

     14:00 – 14:45 The Analysis & Interpretation of Patient Reported Outcomes (PROs)

    Helen Doll (Clinical Outcome Solutions)

     14:45 – 15:00  Break
     15:00 – 15:30 A perspective from IQWiG when assessing treatment effects with PROs

    Christoph Schürmann (IQWiG)

     15:30 – 16:00  Q&A

    Christoph Schürmann (IQWiG)
    Helen Doll (Clinical Outcome Solutions)
    Kim Cocks (Adelphi Values)
    Melanie Calvert (Birmingham University)
    Ingolf Griebsch (Boehringer-Ingelheim)
    Tara Symonds (Clinical Outcome Solutions)

     16:00 Close


       Registration Fee
    PSI Member  £40+VAT 
    Non-Member £135+VAT (price includes PSI membership for the year)

    Please click here to register.

    Please click here to download the flyer. 


    Tara Symonds (Clinical Outcome Solutions)                                                                                                                                                                                            

    Introduction to Patient Reported Outcome (PRO) Measurement


    Abstract: This introduction to PRO measurement will initially cover what a PRO measure is and is not, its history and importance in drug development from various stakeholder perspectives (patient, clinician, payer and regulator).  The latter half of the presentation will concentrate on PRO development and validation.  The presentation will outline the basic psychometric properties to investigate to demonstrate a measure is reliable, valid, and sensitive-to-change.  An overview of deriving a meaningful change threshold using an anchor-based approach will also be discussed.


    Biography: Tara Symonds is Strategic Lead at Clinical Outcomes Solutions providing advice on Clinical Outcome Assessments (COA) strategy from development to dissemination.  Tara has 25+ years of experience in the COA field both negotiating labelling and in disseminating results effectively with payers.  She has worked in numerous therapeutic areas with extensive expertise in Sexual Health, Women’s Health, Pain, and Rare Diseases.  She worked in industry for 16 years, prior to this she worked in academia teaching undergraduate & postgraduate psychology.  She has published 80+ peer reviewed articles and co-authored the book: Cappelleri et al (2014) Patient Reported Outcomes:  Measurement, Implementation and Interpretation, CRC Press.  Tara holds a Doctorate in Health Psychology from the University of Huddersfield, UK.


    Melanie Calvert (Birmingham University)                                             

    Improving the design and reporting of PRO trial data: implementation of the SPIRIT-PRO and CONSORT-PRO Extensions

    Abstract: Patient-reported outcome (PRO) results from clinical trials can provide valuable evidence to inform clinical decision making, pharmaceutical labelling claims and health policy. Despite this, reviews of PRO protocol content and trial reporting demonstrate that the quality of PRO components remains highly variable. The aim of this presentation is to highlight current challenges in trial design and reporting, share examples of good practice, and discuss approaches to implementation and uptake of SPIRIT-PRO and CONSORT-PRO guidance.

    Biography: Professor Melanie Calvert, PhD, is Professor of Outcomes Methodology at the University of Birmingham UK. She is Director of the Centre for Patient Reported Outcomes Research (www.birmingham.ac.uk/cpror) which aims to optimize the use of PROs in clinical trials and routine care, to improve service delivery, enhance patient care and outcomes and ensure that the patient perspective is at the heart of health research and healthcare decision-making. She is the cross-cutting theme lead for PROs research within National Institute for Health Research infrastructure including the Biomedical Research Centre Birmingham, Surgical Reconstruction and Microbiology Research Centre and MedTech Co-operative and is a member of the National Research Ethics Advisory Panel. After serving on the International Society for Quality of Life Research (ISOQOL) Board of Directors she currently Chairs the ISOQOL Standards and Best Practice and Committee and is a member of the Best Practice for PROs in Clinical Trials Task force. She has >150 peer reviewed publications in journals including the NEJM, BMJ, JAMA and the Lancet including: the SPIRIT-PRO Extension (JAMA. 2018; 319(5):483-494) CONSORT-PRO (JAMA. 2013; 309(8):814-822) PRO-Alerts (JAMA. 2013; 310(12):1229-1230) and pathways to impact for medical research (PLoS Med. 2017 Aug 9;14(8):e1002370). Her highly cited work has informed European Society of Cardiology guidelines, NICE and EMA guidance. Prof Calvert works closely with a wide range of national and international collaborators to maximise the reach, influence and impact of her research. She sits on a number of international committees leading national and international strategy for PROs research/implementation including collaborative research with the EORTC led SISAQOL initiative.

     Ingolf Griebsch (Boehringer-Ingelheim)  

    Kim Cocks (Adelphi Values)

    SISAQoL guidance & analysis methods for missing data

    Abstract: This session will cover two topics, firstly an overview of new guidelines aimed at standardizing the analysis of PROs in oncology clinical trials and, secondly, presenting some practical examples of longitudinal analyses dealing with informative missing data.

    Biography: D r Kim Cocks is a Director in the Patient-Centered Outcomes team at Adelphi Values, heading up their statistics and programming team in the UK. Kim has over 20 years’ experience as a medical statistician working in clinical trials and associated methodological research. She has worked across pharmaceutical, medical device, academia and consultancy companies.

    Kim is a Board member for ISOQOL (International Society for Quality of Life Research) and part of an international consortium seeking to standardise the analysis of patient reported outcome data in oncology trials (SISAQOL).


    Helen Doll (Clinical Outcome Solutions)
    The Analysis & Interpretation of Patient Reported Outcomes (PROs) 

    Abstract: This session on the analysis and interpretation of PROs will introduce the main types of statistical analyses that can be applied to the analysis of PRO data and to flag the main issues that should be considered in these analyses, such as multiplicity of endpoints, repeated assessment timepoints, between-group or within-subject analysis, and treatment of missing data. Further discussion of assessment and application of existing thresholds for evaluating meaningful change, such as the use of PDFs and CDFs, and detailed tabular representation of outcome by anchor status, will also be included. The need to ensure that sufficient analyses for the relevant stakeholders are captured in the clinical trial/additional HTA SAP will also be covered, so that these analyses, and their interpretation, take account of local and regional review needs to support HTA submissions.

    Biography: Helen Doll is the Strategic Lead of Quantitative Sciences at Clinical Outcomes Solutions. Helen is a Medical Statistician and Psychometrician who has completed over 25 years of clinical research experience, both in academia and in the pharmaceutical industry. Prior to joining COS in the February of 2018, Helen had led the quantitative team within ICON’s Patient Centred Outcomes group for more than five years. She has also held Senior Medical Statistician and Lecturer positions at the Universities of Oxford and East Anglia. Helen has co-authored more than 130 peer-reviewed papers, is a Fellow of the Royal Statistical Society, and provides statistical reviews for journals such as the British Medical Journal and Quality of Life Research. Helen holds a BSc in Biological Sciences from the University of Warwick, and a Diploma in Applied Statistics, MSc and a DPhil in Medical Statistics from the University of Oxford.


    Christoph Schürmann (IQWiG)

    A perspective from IQWiG when assessing treatment effects with PROs


    Abstract: Assessing patient reported outcomes is part of the (added) benefit assessment of medical interventions. PROs usually are considered to analyse aspects of morbidity and health-related quality of life. For valid conclusions on PRO assessments, suitable and validated instruments are required. This talk gives an overview on PRO assessment criteria applied by IQWiG and commonly experienced challenges when interpreting aggregate data. In this context relevant matters are pre-planned periods of evaluation and cut-off choices along with strategies for handling missing data. Some examples from past assessments are presented to illustrate these issues and their impact on the final assessment. 

    Biography: Christoph Schürmann graduated from the University of Dortmund with a diploma in Statistics in 2002 and with a doctoral degree in 20018. He's been a research associate at the department of Medical Biometry at the Institute for Quality and Efficiency in Health Care (IQWiG) since 20019. His research interests are systematic reviews, meta-analysis, network meta-analysis, surrogate endpoint validation and health-related quality of life assessments. 
     All presenters  Q & A Session

  • A PSI Training Course on Improving Influence and Increasing Impact: Communication Skills for Industry Statisticians

    Dates: 16 – 16 Sep, 2019

    UCB Pharma
    Allée de la Recherche 60, 1070 Anderlecht, Belgium. Brussels
    16th September 2019
    Course runs from: 10:00 – 17:00 (registration from 9:30)

    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 1-day course will lead participants, in a non-threatening and encouraging atmosphere through steps to focus on improving the key skills of making impactful verbal and written communications.

    The first half of the session will cover topics such as poster preparation, written communication documents such as reports and briefing documents and also verbal communication in presentations. The second half of the session will focus on communication in teams and identifying key roles that need to be taken on.

    It is designed to be interactive and lively, with a focus on the statistician rather than the statistics and will include workshops to practise 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: 

    - Preparing poster layout and content
    - Skills and tips for preparing written reports and abstracts
    - Preparing and delivering presentations
    - Effective team communication and key roles
    - Delivering negative messages to teams with positive impact


    Registration costs (includes lunch and refreshments).


    Registration Fee before 16th August 2019

     Registration Fee after 16th August 2019

    PSI Member     

     £345 + VAT

     £395 + VAT


     £440 + VAT (includes PSI membership for 2019)

      £490 + VAT (includes PSI membership for 2019)

    Please click here to register. 

  • Introduction To Industry Training Course 2019

    Dates: 01 Oct, 2019

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


    Final dates to be confirmed

    PSI Member: £1,050 + VAT
    Non-Member: £1,145 + 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.



    For further information contact:

    Alex Godwood & Zelie Bailes

    Sosei Heptares 
    Steinmetz Building
    Granta Park
    CB21 6DG
    United Kingdom


       Email: Alex.Godwood@SoseiHeptares.com ; zelie.a.bailes@gsk.com