Summary of 2018-2019 Meetings

Below is the list of meetings planned in the current academic year.

Date	Venue	Topic	Led by	Materials
23 October 2018	A 130	Discussion of Draft Guidance released by the FDA for 1) Master Protocols, and 2) Adaptive Designs	Deepak Parashar & Nigel Stallard	Master Protocols: Efficient Clinical Trial Design Strategies to Expedite Development of Oncology Drugs and BiologicsLink opens in a new window Adaptive Designs for Clinical Trials of Drugs and BiologicsLink opens in a new window
13 November 2018	A 042	Clinical measurement: the neglected tool in the research design armamentarium	Timothy Hofer
24 January 2019	A 150	Global burden of cancers attributable to infections	Martyn Plummer	Plummer et al (2016)Link opens in a new window de Martel et al (2017)Link opens in a new window Maucort-Boulch et al (2018)Link opens in a new window
25 February 2019	A 039	Meaningful data at scale: opportunities for delivering better treatments to the right patients faster and more safely	Chris Harbron
07 May 2019	A 042	Discussion of new FDA regulatory guidance for 1) Enrichment Strategies, and 2) Rare Diseases	Roundtable Discussion	1. Enrichment Strategies for Clinical Trials to Support Determination of Effectiveness of Human Drugs and Biological ProductsLink opens in a new window 2. Rare Diseases: Natural History Studies for Drug DevelopmentLink opens in a new window
14 June 2019	T0.08/T0.09	A global perspective on measuring early child development in non-Western settings	Gillian Lancaster
24 June 2019	A042	Joint S+E Unit / WCTU Workshop: Multiplicity in confirmatory clinical trials with master protocols Adjusting for subpopulation selection in two-stage designs with time to event data A brief comparison of alternative falls data collection methods in the Prevention of Falls Injury Trials TBC	Nigel Stallard Peter Kimani James Griffin Chen Ji

All meetings take place 11am - 12noon unless stated otherwise.

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