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Masterclass Series

Real-World Studies & Trials
Free Masterclass Live Series 2021

Join our free live Masterclass series 2021 and learn on trial perspectives and methods for real-world studies from a trialist/statistician and an epidemiologist/clinician.

Methodological and statistical aspects explained in clear non-technical terms and illustrated with examples from drugs and devices in multiple therapy areas, including COVID-19.
At the end of each webinar, attendees will have a clear understanding of the topic, the pros and cons of its role for enhancing real world evidence and guidance on overcoming challenges.

Take a look at the different sessions

Don’t miss out on your chance to learn from a leading expert on statistical aspects and register for any or all his masterclasses below.

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TitleDateStart TimeDurationRegister
RW Studies & Trials | Free Masterclass Series 2021: Live Session 1- Non-randomized Comparative Effectiveness Studies SESSION 1: NON-RANDOMIZED COMPARATIVE EFFECTIVENESS STUDIES
(‘The magic of randomization and the reality of real-world studies’)

Non-randomized comparative effectiveness studies may be conducted as a condition of approval of a new product, as well as to demonstrate the benefits in under-studied populations and to compare benefits from different products.

Topics:
• Pros and Cons of Non-Randomized Studies of Interventions for Effectiveness
• Studies of Effectiveness, with examples from several therapy areas
• Superiority versus non-inferiority studies
• Types of Real-World Data for Effectiveness Studies
• Data Quality and Completeness
• External controls for one-arm trials in rare diseases
• Guidance on conducting non-randomized comparative effectiveness 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 Committees

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:
March 17, 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.
17 Mar, 202117:00 CET1 hour
Register
RW 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 and are certain propensity scores methods better than others?

Topics:
• Propensity scores will be introduced and explained in a non-technical way.
• Various methods of propensity scores will be described.
• The performance of the various methods will be illustrated with case studies, and compared with covariate adjustment
• Limitations of propensity scores methods 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 Committees

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, 202117:00 CEST1 hour
Register
RW Studies & Trials | Free Masterclass Series 2021: Live Session 3 - Non-Randomised Comparative Safety Studies SESSION 3: NON-RANDOMISED 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 low rates and long latency periods for adverse events
• Examples of Safety Studies
• Types of Real-World Data 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 Committees

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, 202117:00 CEST1 hour
Register
RW 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 identifies patients who would benefit and help inform eligibility for future trials and RW studies.
Topics:
• A new method of individualizing 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
• A brief review of benefit-risk models used for regulators
• Benefits of this new method for Clinical Development, Value, Market Access and Marketing

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 Committees

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, 202117:00 CEST1 hour
Register

SESSION 1

  • 17 MARCH 2021
LEARN MORE

SESSION 2

  • 21 APRIL 2021
"Stuart Pocock Masterclass 2"LEARN MORE

SESSION 3

  • 19 MAY 2021
"Stuart Pocock Masterclass 3"LEARN MORE

SESSION 4

  • 16 JUNE 2021
"Stuart Pocock Masterclass 4"LEARN MORE

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