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Forum
Introduction: Over the last decade, significant strides have been made in medical research, which leads to great improvement in human health. During this period, Chinese government has made important progress in promoting and managing medical innovations. Chinese FDA is now a formal agency member of the international council for harmonisation of technical requirements for pharmaceuticals for human use (ICH). With further integration of China into the global pharmaceutical research and development, how government regulatory agencies, the related law and regulations can promote industry innovation, while enhance their accountability and responsibility remains an important question. This forum is organized to address this need.
Program: This forum provides a platform for high-level discussions on this topic by Chinese and US scholars from academia, experts from the Chinese Food and Drug Administrations, and R&D experts from biomedical industries. On June 8-9, 2018, the forum will host keynote speech sessions, invited talks, and panel discussion sessions. With collaborations from Chinese evidence based medicine association, we will discuss methods and policy related to monitoring drug safety, novel clinical trial design, and applications of modern statistical, AI and machine learning methods in drug development. On June 10, 2018, a half-day short course will be offered on "Statistical Methods for Medical Product Safety Evaluation."
Goals: Through this brainstorming and exchange, we want to identify research priorities and collaborative mechanisms for international scholars from academia, regulatory agencies and industry working together to promote biomedical innovations in an efficient and orderly manner.
Format: Informal discussion on biomedical innovations and role of regulatory science.
The Workshop on June 8-9, 2018 is free (you must register before May 31 to reserve a spot) and the half-day short course on June 10 is RMB800.
A Half-Day Short Course
This half-day short course is based on the forthcoming book published by Chapman & Hall (available July 9, 2018): Medical Product Safety Evaluation: Biological Models and Statistical Methods
Abstract: Over the past decade there has been a greatly increased focus on the safety evaluation of medical products. Safety data are routinely collected throughout preclinical in-vitro and in-vivo experiments (e.g., living cells and animal models), clinical development (e.g., randomized clinical trials) and post-approval studies and monitoring. While the majority of clinical studies are designed to investigate the hypothesized efficacy of a compound, safety outcomes, on the other hand, are not generally defined a priori (with exceptions to be discussed in the short course). This brings a number of challenges to statisticians on how to best analyze the high-dimensional safety data, in order to detect safety signals earlier, and at the same time, reduce the rates of false signals and false non-signals. Depending on the questions of interest and the systems for collecting safety data, statistical methods applied to safety data analysis could differ dramatically. This half-day short course will present cutting-edge biological models and statistical methods that are tailored to specific objectives and data types for safety analysis and benefit-risk assessment. Some frequently encountered issues and challenges in the design and analysis of safety studies are discussed with illustrative applications and examples.
Background knowledge: Some background in drug development including basic concepts, practice, and regulation on safety data reporting, analysis and result interpretation in nonclinical and clinical studies is helpful. Basic knowledge of commonly used statistical methods (e.g., categorical data analysis, survival analysis, Bayesian methods, meta-analysis, etc.) and machine learning techniques is assumed. The course will begin with a review of fundamental concepts in safety data analysis with regulatory guidelines and scientific plausibility of drug-induced safety concerns (e.g., QTc prolongation, hepatotoxicity, nephrotoxicity, etc.) and continue to statistical methods for pre-licensure safety analysis and post-licensure safety surveillance.
Course learning objectives: The audience will learn the commonly used as well as cutting-edge statistical methods that are tailored for specific safety questions, safety data types and benefit-risk assessment. Examples are given throughout the presentation to illustrate the applications of the methods.
