• Personalised Medicine: Statistics for Companion Diagnostics

    Dates: 04 – 04 May, 2017

    PSI Webinar
    Personalised Medicine: Statistics for Companion Diagnostics
    Date for Webinar: Thursday 4th May. 2-3.30pm UK time

    Personalised medicines - which are designed to treat particular groups of patients -  are becoming increasingly prominent. In order to identify patients suitable for treatment a companion diagnostic assay is often needed. The Personalized Medicines Coalition (PMC) recently published an article stating that 25% of NME approved by FDA in 2016 included a companion diagnostic.

    This webinar will introduce and examine some of the considerations required for statisticians working in the field of companion diagnostics and will include information from an FDA (CDRH) speaker and perspectives/ case-studies from representatives from both a pharmaceutical company and a diagnostic company.



    Meijuan Li, CDRH
    Peter Cooper, Qiagen
    Rachel Hodge, AstraZeneca


    Meijuan Li (CDRH)

    Applications of personalized medicine are becoming increasingly prominent. A companion diagnostic assay (CDx) is often desired for patient enrollment in device-drug pivotal clinical trial(s) so that FDA can ensure that appropriate clinical and analytical validation studies are planned and carried out for CDx. However, such a requirement may be difficult or impractical to accomplish. A clinical trial assay (CTA) instead of CDx may be used for patient enrollment in drug-device pivotal clinical trial(s). A supplemental agreement study of CDx and CTA will be required to bridge the clinical results from CTA to CDx. In this webinar, we will discuss statistical challenges in study design and data analysis for bridging study. Particularly, we aimed to provide statistical methods on how to estimate the drug efficacy in CDx intended use population using results from bridging study and CTA-drug pivotal clinical trial.

    Peter Cooper (Qiagen)
    Perspective from Diagnostic Company

    Rachel Hodge (Astrazeneca)
    Perspective/Case-study from Pharmaceutical Company

    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.***

  • Expert Working Group on Confidentiality of Interim Results

    Dates: 11 May, 2017

    The confidentiality of interim results of on-going trials is a topic on the agenda of the EMA Biostatistics Working Party (BSWP).  ICH E9 states that all staff at the investigational sites and at sponsor (except those directly involved with the execution of an interim analysis) should remain blinded to any interim analysis results. The BSWP recognised that this advice may need to be re-evaluated, especially for some complex situations (eg the use of interim analyses in Cardiovascular Outcomes Trials to rule out harm or for gene therapy where the full results may not be available for 15 years).

    The BSWP therefore asked the PSI/EFSPI Regulatory Committee to set up a PSI/EFSPI expert working group on this topic and to provide thoughts and recommendations.  The expert working group has been formed under the leadership of Jürgen Hummel (PPD), Erika Daly (ICON) and Robin Mukherjee (Astra Zeneca), and are planning to meet face to face on 11 May with the aim to get back to the BSWP by September 2017.

  • 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

  • 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.


  • 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