• Patient Engagement in Clinical Trials Webinar

    Dates: 13 – 13 Jun, 2017

    PSI Webinar
    Patient Engagement in Clinical Trials
    Date for Webinar: Tuesday 13th June 2:30-3:30pm UK time

    Patients have long been an important part of clinical drug development – without them, there would be no new medicines. Recently, there has been a fundamental shift in their involvement in the drug development process. Today, patients are highly active in engaging in discussions about their disease, what they look for in new treatments, and how clinical trials are designed and conducted.

    Following on from the successful and thought-provoking presentation at last year’s PSI conference by Paul Wicks from PatientsLikeMe, this webinar will continue to explore the ways in which patients are influencing the design of new clinical trials.  We have two speakers who bring different experience and perspectives on this subject:

    Speaker 1 
    Dr Cathy EmmasPartnership Director, Patient Centricity, AstraZeneca
    Title: Patient-centric medicines development – the value of online health communities

    Abstract: How AstraZeneca’s collaboration with the PatientsLikeMe is accelerating our ability to generate the timely and relevant patient insight that enables informed decision making within our R&D programs. What patient-generated health data tells us about symptoms and outcomes that matter to patients. Optimisation of clinical trials from the patient perspective.

    Biography: Cathy is the Partnership Director in AstraZeneca’s global Patient Centricity team where she leads a 5 year strategic collaboration with the PatientsLikeMe online health network. This alliance was established to accelerate our ability to generate the right patient insight that enables informed decision making within our R&D programs and shape healthcare delivery. In the first two years the collaboration has linked the experiences of over 70,000 patients into our lifecycle teams and patient preferences have helped shape 12 clinical studies across 7 diseases. 

    Sue Pavitt

    Professor Sue Pavitt, Dental Translational and Clinical Research Unit, University of Leeds

    Title: Achieving Effective Patient Public Involvement in Clinical Trials: “No research about us without us”

    Abstract: Patient public involvement in medicine research and development has gained significant momentum. Adopting a patient-centric approach in clinical trials and research is important to ensure new treatments embrace what is important to patients. Achieving effective Patient Public Involvement & Engagement (PPIE ) partnerships enhances the relevance of clinical research and improved likelihood of delivering patient benefits. PPI also contributes to the operational efficiency and success in clinical trial design, ethical approval, conduct and dissemination reach; collectively building cross sector communication and partnerships may enhance market head room long term. I will provide a background to patient public involvement and establishing effective partnerships and illustrative case examples that support patient awareness of their treatment options and healthcare choices. I will introduce EUPATI and its role in meeting the educational needs to deliver patient centric medicine R&D and facilitate partnerships between patients-academia and industry in clinical research. We are in an era of a paradigm shift in patient-centric clinical trials, by strategically bringing the patient lived experience to the forefront has the potential to change fundamentally how health care is practiced.

    Biography: Sue Pavitt - Prof in Translational & Applied Health Research, University of Leeds. Her PhD was in Human Cancer Genetics and she had a high profile career working with Prof Sir Walter Bodmer mapping the first colorectal cancer gene. She worked on the Human Genome Project at UCL, Oxford and UCSF, USA. In 1998 she was appointed as the Founding Director of TayRen – the premier Scottish multidisciplinary Primary Care Research network and the academic focus of her career changed to applied health research. She became the Divisional Director at the Clinical Trials Research Unit, Leeds and has since gone on to Head the Division for Applied Health and Clinical Translation and is Director of the Dental Translation and Clinical Research Unit. She is a Specialty lead for the Oral & Dental Health National Institute of Health Research (NIHR) Clinical Research Network. She is Chair of Multiple Sclerosis Clinical Trials Network. She is a Board Member of the MRC-NIHR Efficacy & Mechanistic Evaluation and in this capacity evaluated clinical trial design. Her research portfolio spans several disease areas and is characterized by forging effective, multi-disciplinary research partnerships between clinicians, academics, sometimes industry and always patients; developing methodological sound projects that are patient-centric with research questions tailored to clinical priorities to maximize impact and patient benefit. Sue is passionate about patient involvement in research with >30 years’ experience. She is the Academic Lead for EUPATI-UK – European Patient Advocacy for Therapeutic Innovation- a pan-European Innovative Medicines Initiative, led by the European Patients' Forum, in partnership with patient organizations, universities, not-for-profit organizations and pharmaceutical companies. EUPATI’s goal is to increase capacities and capabilities of well-informed patients to be effective advocates/advisors in medicines research.

    CLICK HERE TO REGISTER! (Attendance is free)

    iCalendar PLACEHOLDER
     - PLEASE REGISTER WITH PSI to attend. You will be sent dial-in details for the webinar during the week of the webinar as long as you have registered with PSI first.

    ***Please note that this registration provides PSI with your details in order to register interest for the Webinar (please note there is a limited number of participants so please only register if you plan to attend).

    In the week before the webinar you will be sent another email and you will need to REGISTER AGAIN with the WEBINAR (GoToWebinar) to get your personal dial-in details to attend the webinar.***

  • BBS / PSI One-day Event on Cancer Immunotherapy

    Basel | Dates: 15 Jun, 2017

    Immunotherapy treatments use parts of a person’s immune system to fight disease. In the recent past, immunotherapy has become an important part of treating some types of cancer e.g. melanoma, NSCLC. Studies of these treatments have resulted in a number of observations that have implications for the statistician e.g. delayed treatment effects, long term survivors etc. This joint Basel Biometric Society / PSI one day meeting will present an overview of the science and potential statistical challenges across a range of topics covering early and late phases of development, regulatory and health technology assessments. The speakers from Academia, Regulatory Bodies and Pharma will share their thoughts, ideas and experiences, including case studies. There will be plenty of time for questions and interactions with colleagues.

    The meeting will take place on June 15th 2017 in Basel at the Roche IT Centre. Further details on the agenda will follow but for now…please save the date!

    If you have any questions please feel free to contact one of the organisers from the BBS or PSI Scientific Committee: david.lawrence@astrazeneca.com, dominik.heinzmann@roche.com or emanuela.pozzi@roche.com


  • PSI One Day Meeting: Career Young Statisticians

    Reading | Dates: 19 – 19 Jun, 2017
    The aim of this meeting is to provide a relaxed environment for career young statisticians
    where they can present and discuss various statistical topics and interact/network with other statisticians in similar positions to themselves. The PSI conference and similar events can be daunting for some attendees both in terms of who is in the audience and also in being happy that what they present is deemed new and original. For this one day meeting the audience will be peers with similar levels of experience and will include content of interest to career young statisticians. In addition to presentations from fellow statisticians there will be a soft skills workshop on explaining statistics to non‐statisticians and ample opportunity to connect with colleagues across the industry.


    Registration Costs:

    PSI Members   £25 + VAT
    Non-Members  £95 + VAT


    The agenda for the meeting can be found below:

    9.30 -9.55


    9.55 – 10.00

    Welcome and Introduction

    10.00 – 11.00

    One label with different interpretations…Statistical lead, what does it really mean?


    Charlotte Eden and Lucie Tesarova, QuintilesIMS

    11.00 – 11.20


    11.20 – 11.50

    Exploring recent developments in the MAMS methodology for designing an adaptive trial


    Julia Abery, University of Reading

    11.50 – 12.20

    Seamless Study Designs & Real-time Data Capture Using Electronic Devices


    Rhian Jacob, Roche

    12.20 – 13.20


    13.20 – 14:20

    Training session: Explaining statistics to non-statisticians


    James Matcham, AstraZeneca / PSI Training Committee

    14.20 – 14.40


    14.40 – 15.10

    Introduction to Pharmacokinetics


    Laura Cope, Quanticate

    15.10 – 15.40

    AdePro – A new Perspective on Safety Profiles


    Nicole Mentenich, Christoph Tasto and Bastian Becker, Bayer AG

    15.40 – 16.00


    16.00 – 16.30

    Marginal and conditional structural mean models for optimising Dynamic Treatment Regimes


    Nirav Ratia, GSK




     One label with different interpretations…Statistical lead, what does it really mean?

    Charlotte Eden and Lucie Tesarova, QuintilesIMS

    Exploring the role of the Statistical lead from different perspectives. Focusing on life in a CRO to experiences in Pharma with audience participation to discuss how we work on some key factors throughout the life of a study.


    Exploring recent developments in the MAMS methodology for designing an adaptive trial

    Julia Abery, University of Reading

    Multi-arm adaptive trials allow several new drugs to be assessed simultaneously, potentially giving improved efficiency over conventionally designed trials. In such a trial, data accumulating during the study are utilised to inform decisions about how the remainder of the trial should be conducted. Several different methodological approaches have been developed for multi-arm adaptive trials and a number of studies have compared the performance of different subsets of these proposed methods. The comparisons have not, however, considered the so-called MAMS approach, since methodology for the latter did not incorporate strong control of the family-wise error rate (FWER). Recently, the MAMS approach has been extended such that strong control of the FWER can be guaranteed. Furthermore, an automated process has been developed which can produce efficient designs for trials with any number of stages and treatment arms.Since MAMS is relatively easy to understand and implement, we set out to explore these developments and to compare MAMS to other well established methods.We show how MAMS compares favourably with the more established combination method for some scenarios and explore how use of a novel selection rule may offer a further option within MAMS methodology.


    Seamless Study Designs & Real-time Data Capture Using Electronic Devices

    Rhian Jacob, Roche

    Developing a new drug in a highly competitive environment necessitates a fast to market approach. BERGAMOT is a multiple cohort seamless phase II/III study evaluating Etrolizumab in Crohn’s Disease. Key study endpoints are captured using electronic devices, providing high volume of data in real-time. This talk describes the opportunities and challenges for a statistician leading a phase II readout within a phase III framework, with discussion on novel data capture methods; is the industry ready to handle device data?


    Training session: Explaining statistics to non-statisticians  

    James Matcham, AstraZeneca / PSI Training Committee



    Introduction to Pharmacokinetics

    Laura Cope, Quanticate

    Pharmacokinetics is the study of the effect of the body on the drug. The pharmacokinetic profile maps the concentration of the drug in the body over time tracking how the drug is absorbed, distributed, metabolised and excreted by individuals. Drug concentration is linked to both efficacy and safety and hence pharmacokinetic studies form the basis of much earlier phase clinical trials. Pharmacokinetic profiles are often described using summary measures such as the area under the curve (AUC) and the maximum concentration (Cmax) but how are these parameters derived? What models are used and what assumptions do they make? This presentation will describe the derivation of pharmacokinetic parameters for both intravenous and extravascular dosing, first looking at a single dose and then extending to multiple dosing schedules.


    AdePro – A new Perspective on Safety Profiles

    Nicole Mentenich, Christoph Tasto and Bastian Becker, Bayer AG

    The database in a clinical trial contains vast information on adverse events, involving hundreds of different adverse event terms with varying severity grades and different start and end dates. Despite this plethora of information, insight into the adverse events in a clinical study is usually limited to simple summary tables of absolute and relative numbers of adverse event occurrences. AdEPro – an innovation of Bayer’s Biostatistics Innovation Center – is an unparalleled approach to audio-visualize the safety profile of both the individual patient and of the entire study cohort, which enables every study team member to experience the study and emphasize with the patients. The AdEPro app depicts the temporal progress of all adverse events in every study subject and enables the user to give profound answers to complex questions surrounding adverse events such as the frequency, duration and correlation of adverse events of interest.


    Marginal and conditional structural mean models for optimising Dynamic Treatment Regimes

    Nirav Ratia, GSK

    Marginal structural models (MSMs) are casual models of dynamic treatment regimes (also known as treatment strategies or policies) designed to adjust for time-dependent confounding. These models are designed to adjust for exposures or treatment that vary over time, and standard approaches for adjustment of confounding can be biased when there exist time-dependent confounding. Dynamic treatment regimes (DTRs) provide the basis for statistical analysis in personalised medicine. A DTR is a decision rule that guides the treatment choices over the course of the therapy. The sequence of treatments a patient receives depends on the patient’s health status, response to prior treatment and other patient characteristics.


  • PSI Webinar: Data Sharing and Data Privacy - what every statistician needs to know

    Dates: 21 – 21 Jun, 2017

    EFSPI Data Sharing Working Group

    Wednesday 21st June 2017
    2.30-4.30pm (UK time)

    Data Sharing and Data Privacy - what every statistician needs to know

    Data sharing, data transparency and data privacy are areas that continue to evolve. For example, EMA Policy 70 is now effective with proactive publication of submitted clinical overviews and study reports. It is becoming more common for clinical trial data to be used to support scientific questions beyond the objectives of the original study.

    The intent of this webinar is to provide an outline to pharmaceutical statisticians of key issues and concepts everyone dealing with and sharing patient level data should be aware of.

    Presentation #1 Sharing clinical trial data externally – key data privacy concepts every statistician should know (Janice Branson and Nicola Orlandi (Novartis))

    Presentation #2 Data Sources to help inform drug development – what you give is also what you get (Sally Hollis (Phastar) and Rebecca Sudlow (Roche))

    There will be opportunities for questions and discussion during this session.

    For details contact the organisers from the PSI Scientific Committee: tcornelius@cmedresearch.com or Julia.Saperia@mhra.gov.uk

    Registration for this webinar is free. Please click here to register!

  • 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


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


    After 30th May 2017

    PSI Members

    £595 + VAT


    £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.


  • 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. 


  • 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.

    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.

  • 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 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?



    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.


    For further information contact:

    Alex Godwood

    MedImmune Ltd, Milstein Building, Granta Park

    Great Abington, Cambridge, CB21 6GH

    Tel: 0203 7496241

    Email: godwooda@MedImmune.com