Real-World Evidence & Trials
Free Masterclass Live Series 2021
Join our masterclass series to learn about perspectives on real-world evidence studies from a trialist / statistician and epidemiologist / clinician, explained in clear non-technical terms and illustrated with examples from drugs and devices in multiple therapy areas.
Speakers
Key Speaker
Stuart Pocock
Professor of Medical Statistics, London School of Hygiene & Tropical Medicine
Author of > 500 papers, including 70+NEJM/Lancets, mainly of clinical trials and epidemiology; extensive experience of EMA/FDA and Data Monitoring Committee (including the Covid-19 adaptive platform DISCOVERY trial)
Chairman
Nawab Qizilbash
Senior Clinical Epidemiologist, OXON Epidemiology
Honorary Associate Professor in Pharmacoepidemiology, London School of Hygiene & Tropical Medicine and Clinical Observer, Internal Medicine, Madrid Hospitals.
Formerly: Director, Clinical Epidemiology, GSK and Honorary Consultant Physician, Radcliffe Hospitals, Oxford
Who should attend
This Masterclass series is intended for a wide audience including: Epidemiology, HEOR, Safety, Statistics, Medical Affairs, Market Access, Marketing, Project Management and Outsourcing professionals in biopharmaceutical and device companies*.
You will learn about the role and pros and cons of Real-World Data studies compared with trials.
Guidance to overcome challenges in future Real-World Data studies will be discussed with Q&A sessions for technical and non-technical questions.
Take a look at the different sessions
Don’t miss out on your chance to learn from a leading expert and register for any or all masterclasses below.
Let us know if you cannot attend any live session and we can discuss alternative arrangements.
| Title | Date | Start Time | Duration | Register |
|---|---|---|---|---|
| RWE Studies & Trials | Free Masterclass Series 2021: Live Session 2 - The Tyranny of Propensity Scores: The good and the bad SESSION 2: THE TYRANNY OF PROPENSITY SCORES: THE GOOD AND THE BAD Almost every non-randomized comparative study is expected to consider analysis using propensity scores. However, are they always the best solution to address selection bias? In what circumstances are certain propensity scores techniques better than others? TOPICS: • Propensity scores will be introduced and explained in a non-technical way. • Various techniques based on propensity scores will be described. • The performance of the various techniques will be illustrated with case studies and compared with covariate adjustment. • Limitations of propensity scores techniques will be discussed. • Guidance for which methods to use and avoid in various scenarios will be provided. • Examples of propensity scores methods used in COVID-19 treatment studies will be illustrated from a real-time systematic review. SPEAKERS: Stuart Pocock, Professor of Medical Statistics, London School of Hygiene & Tropical Medicine Author of more than 500 papers, including 70+NEJM/Lancets, mainly of clinical trials and epidemiology; extensive experience of EMA/FDA and Data Monitoring Committee (including the Covid-19 adaptive platform DISCOVERY trial) Nawab Qizilbash, Senior Clinical Epidemiologist, OXON Epidemiology Honorary Associate Professor in Pharmacoepidemiology, London School of Hygiene & Tropical Medicine and Clinical Observer, Internal Medicine, Madrid Hospitals. Formerly: Director, Clinical Epidemiology, GSK and Honorary Consultant Physician, Radcliffe Hospitals, Oxford DATE: Wednesday, 21 April 2021 at 5pm CET | 4pm UK | 11am EDT | 8am PST AGENDA: Chair: Dr Nawab Qizilbash, Senior Clinical Epidemiologist, OXON and Honorary Associate Professor, London School of Hygiene & Tropical Medicine: - Welcome and introductions (5 minutes) Key Speaker: Stuart Pocock - Programme: (45 minutes) - Q&A session (10 minutes) DETAILS: - We will be using GoToWebinar. - You can join our session by using a Mac, PC or a mobile device. | 21 Apr, 2021 | 17:00 CEST | 1 hour | Register |
| RWE Studies & Trials | Free Masterclass Series 2021: Live Session 3 - Non-Randomized Comparative Safety Studies SESSION 3: NON-RANDOMIZED COMPARATIVE SAFETY STUDIES Approval of new drugs is often conditional on data collection and secondary data PASS studies. TOPICS: • Pros and cons of non-randomized studies of interventions for safety. • Practical implications for studies of low exposure and rates and long latency periods for adverse events. • Examples of safety studies. • Evaluating safety of drug exposure in pregnancy. • Types of Real-World Data (RWD) for safety studies. • Data quality and completeness. • Guidance on conducting PASS studies. SPEAKERS: Stuart Pocock, Professor of Medical Statistics, London School of Hygiene & Tropical Medicine Author of more than 500 papers, including 70+NEJM/Lancets, mainly of clinical trials and epidemiology; extensive experience of EMA/FDA and Data Monitoring Committee (including the Covid-19 adaptive platform DISCOVERY trial) Nawab Qizilbash, Senior Clinical Epidemiologist, OXON Epidemiology Honorary Associate Professor in Pharmacoepidemiology, London School of Hygiene & Tropical Medicine and Clinical Observer, Internal Medicine, Madrid Hospitals. Formerly: Director, Clinical Epidemiology, GSK and Honorary Consultant Physician, Radcliffe Hospitals, Oxford DATE: May 19, 2021 at 5pm CET | 4pm UK | 11am EDT | 8am PST AGENDA: Chair: Dr Nawab Qizilbash, Senior Clinical Epidemiologist, OXON and Honorary Associate Professor, London School of Hygiene & Tropical Medicine: - Welcome and introductions (5 minutes) Key Speaker: Stuart Pocock - Programme: (45 minutes) - Q&A session (10 minutes) DETAILS: - We will be using GoToWebinar. - You can join our session by using a Mac, PC or a mobile device. | 19 May, 2021 | 17:00 CEST | 1 hour | Register |
| RWE Studies & Trials | Free Masterclass Series 2021: Live Session 4 - Individualizing Benefit-Risk SESSION 4: INDIVIDUALIZING BENEFIT-RISK Conventional methods of benefit-risk overly focus on overall results; subgroups have limitations, and the relative importance of events may not be considered. Individualizing benefit-risk more precisely would benefit identification of patients for treatment and help eligibility for future trials and RWE studies. TOPICS: • A new method of individualising benefit-risk will be introduced and explained. • Case studies will show its application from trials. • Limitations will be outlined. • Applicability to observational studies will be provided. • How this method sits with current benefit-risk models used by regulators and reimbursement agencies. • Benefits of this new method for Clinical Development, Value, Market Access, guidelines and patient management. SPEAKERS: Stuart Pocock, Professor of Medical Statistics, London School of Hygiene & Tropical Medicine Author of more than 500 papers, including 70+NEJM/Lancets, mainly of clinical trials and epidemiology; extensive experience of EMA/FDA and Data Monitoring Committee (including the Covid-19 adaptive platform DISCOVERY trial) Nawab Qizilbash, Senior Clinical Epidemiologist, OXON Epidemiology Honorary Associate Professor in Pharmacoepidemiology, London School of Hygiene & Tropical Medicine and Clinical Observer, Internal Medicine, Madrid Hospitals. Formerly: Director, Clinical Epidemiology, GSK and Honorary Consultant Physician, Radcliffe Hospitals, Oxford DATE: June 16, 2021 at 5pm CET | 4pm UK | 11am EDT | 8am PST AGENDA: Chair: Dr Nawab Qizilbash, Senior Clinical Epidemiologist, OXON and Honorary Associate Professor, London School of Hygiene & Tropical Medicine: - Welcome and introductions (5 minutes) Key Speaker: Stuart Pocock - Programme: (45 minutes) - Q&A session (10 minutes) DETAILS: - We will be using GoToWebinar. - You can join our session by using a Mac, PC or a mobile device. | 16 Jun, 2021 | 17:00 CEST | 1 hour | Register |
