The lecture theatre was packed full of students and faculty members who were all eager to listen to the Division of Science and Technology (DST) distinguished guest Prof Tze Leung Lai on 4 December.

Prof Tze Leung Lai is the Ray Lyman Wilbur Professor of Statistics and by courtesy, also of Biomedical Data Science, and Computational and Mathematical Engineering at Stanford University.

Prof Lai received the Committee of Presidents of Statistical Societies (COPSS) Presidents' Award in 1983, which is referred to as the 'Nobel Prize of Statistics'.

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Prof Tze Leung Lai

Famed statistician and DST Professor Prof Fang Kaitai introduced Prof Tze Leung Lai to give his talk that was titled ‘Real World Data, Real World Evidence, and Decision Analytics for Precision Medicine and Health’.

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Prof Lai receiving a souvenir from UIC President Prof Tang Tao

The areas of the talk included Real World Data and Evidence (RWD & E), a summary of the framework of FDA's RWE programme in the US, multiplicity issues and casual inference using RWD as well as mobile devices and wearables.

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The lecture theatre is full of students and faculty members from Prof Lai's lecture

Prof Lai began by explaining that Real World Data (RWD) and Real World Evidence (RWE) have been increasingly used in health care decision-making since the passage of the 21st Century Cures Act on December 9, 2016, which requires FDA to develop a framework and guidance for evaluating RWD and RWE to support approvals of new drugs or devices, or new indications for previously approved drugs, and to support post-approval studies for monitoring safety and adverse events for further regulatory decision-making.

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A student asking Prof Lai a question

Prof Lai went into depth about pharmaceutical companies using RWD and RWE to support clinical development activities and to seek evidence to inform health technology assessment (HTA) decisions, the healthcare community uses RWD and RWE to develop guidelines and decisions to support medical practice and to assess treatment patterns, costs and outcomes of interventions.

He elaborated that although high-speed computing tools and machine learning algorithms have been conveniently applied to RWD, there are still substantial challenges in deriving RWE from RWD and to use the RWE in healthcare decision-making. "We are really living in the era of Big Data", Prof Lai said.

Case studies were given throughout the presentation that aimed to provide the audience with practical decision-analytic approaches to decision-making during product development, regulatory approval, and healthcare delivery.

A student asked a question about the effectiveness of random trial standards to which Prof Lai responded that random trials are needed in the pharmaceutical industry and that it is a growth area when related to statistics.

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Prof Lai with President Tang and DST faculty members

At the very end UIC President Prof Tang Tao came on to the stage to present Prof Lai with a souvenir before being joined by other faculty members for a group photo to close the lecture.

Reporter: Samuel Burgess
Photographer: Ben Wen
Editor: Deen He
(from MPRO with thanks to the ELC)