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09 December 2019

Véronique Robert, Guido Thömmes, Oliver Sailer

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Véronique Robert, Guido Thömmes, Oliver Sailer

Quantitative methods to support decision-making in clinical drug development already exist, but may be unknown or unused by pharmaceutical companies. We performed a survey among pharmaceutical companies, targeting people with different profiles (statisticians, non-statisticians and decision-makers) working at different stages of the clinical development (study level, development level or portfolio level). This survey allowed us to analyze which quantitative methods are known, which quantitative methods are used (or not), what benefit is expected from this kind of methods, and what are the needs for a larger use of quantitative methods to support decision-making. It permitted to understand the gaps and some of the issues associated to the use of such methods in drug development. The webinars are intended to share the learnings from the survey and to promote different quantitative methods for decision-making.

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09 December 2019

José Pinheiro, Björn Bornkamp, Tobias Mielke, France Mentré, Rob Hemmings

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José Pinheiro, Björn Bornkamp, Tobias Mielke, France Mentré, Rob Hemmings

Longitudinal data, i.e. data that arises from repeated observations of the variable over a period of time, has long been put forward as one way to improve to the efficiency of drug development. However, even though there is a rich statistical methodology for longitudinal data, there is no full, wholehearted uptake of these methods in pharmaceutical statistics. The purpose of this webinar is to explore the use of longitudinal modelling across drug development, highlighting its opportunities (such as usage as primary analyses, or for improved decision making at interim analyses) and caveats. One important aspect to be discussed is the evaluation of the efficiency of (parametric) longitudinal modelling versus standard cross-sectional approaches, and factors based upon which one approach might be preferable over the other.

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05 November 2019

Cynthia Huber, Christoph Muysers, Bodo Kirsch & Anna Berglind

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Cynthia Huber, Christoph Muysers, Bodo Kirsch & Anna Berglind 

The webinar is on Subgroup Analyses and our presenters are Cynthia Huber from the Department of Medical Statistics, University Medical Centre Gottingen and Christoph Muysers and Bodo Kirsch from Bayer. The chair of the webinar is Anna Berglind from AstraZeneca. 

The papers discussed are: 
* (PSI) A comparison of subgroup identification methods in clinical drug development: Simulation study and regulatory considerations – Cynthia Huber, Norbert Benda and Tim Friede 
* (DIA) A Systematic Approach for Post Hoc Subgroup Analyses With Applications in Clinical Case Studies – Christoph Muysers et al.

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11 October 2019

Kat Greenbrook

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Kat Greenbrook

Data visualisation is often used as a method to uncover insight but can also be used as an effective way to communicate data (or tell data stories!). Find out where data stories fit into the analytics cycle, how to uncover a data story from the noise of numbers, and how design can be used to help communicate it. As a bonus, Kat will step you through a template for you to discover the stories in your own data.

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11 September 2019

Dr Chris Holmes

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Dr Chris Holmes New measurement technologies such as wearable devices coupled with AI algorithms, that can learn from large scale streaming data, have the potential for improved evaluation and monitoring of treatment interventions. In this talk we review the prospect for AI to better characterise population activity variation through wearable tech including an analysis of accelerometer data from 100,000 participants in UK BioBank

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11 September 2019

Frances Kendall

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Frances Kendall This talk will set the stage on why Data Science is needed to support a New Clinical Development paradigm and what are the drivers of change. It will then put forward an idea on what that Paradigm could look like with examples of work that demonstrate this direction.

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11 September 2019

Ken Hanscombe

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Ken Hanscombe An application of elastic net and random forest classifiers to Crohn’s disease (CD) risk in asymptomatic first-degree relatives (FDRs) of CD patients, using multiple environmental and genetic predictors.

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11 September 2019

Chris Harbron

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Chris Harbron Roche has been successful in building an internal advanced analytics community consisting of over 750 data scientists from across the global Roche organization as well as establishing a number of external advanced analytics partnerships. This talk will discuss how Roche have approached this effort as well highlighting some of the successes and challenges, including crowd sourcing the internal community to tackle key scientific research questions using machine learning.

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17 July 2019

Tara Symonds

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Tara Symonds 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. 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.

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17 July 2019

Melanie Calvert

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Melanie Calvert 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. 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.

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