Wednesday, November 7, 2018
Title: What Does It Mean by a Device’s Benefits Outweigh the Risks? Benefit-risk Assessment of Medical Devices for Regulatory Decision Making
Presenter: Martin Ho, Associate Director for Quantitative Innovations, CDRH, FDA
Date and Time: Monday, November 5, 2018, 1:00 p.m. – 2:00 p.m. Eastern time
Sponsor: Section on Medical Devices and Diagnostics
Registration Deadline: Friday, November 2, at 12:00 p.m. Eastern time
Statisticians’ instrumental roles in ensuring appropriate design, conduct, analysis, and interpretation of clinical studies have been widely recognized in scientific community. Yet clinical evidence is one of multiple important factors to inform regulatory decision making at CDRH. To appreciate the regulatory values of clinical and non-clinical evidence in submissions, statisticians may benefit with a better understanding of how CDRH evaluates thousands of distinct medical device types. To promote policy transparency and consistency, CDRH first published a guidance document on factors to be considered for benefit-risk determinations for PMA, de novo, and HDE decisions. To further explain individual factors listed in the 2013 “parent” guidance, CDRH has released subsequent “children” guidance documents. The suite of benefit-risk guidance documents has recently been completed by the release of a draft guidance in September 2018 on acceptable level of uncertainty.
In this webinar, I will first describe CDRH’s benefit-risk framework and its relationship to CDER’s own framework. Next, I will discuss individual factors of the framework in details, including patient preference information, patient-reported outcomes, and uncertainty. Next, I will take a step back and explain the relationship between statistical significance and clinical meaningfulness. Finally, I will provide some interesting examples for illustrations.
Member of the Section for Medical Devices and Diagnostics (MDD): $0
ASA Member: $65
Each registration is allowed one web connection. Sound is received via audio streaming from your computer’s speakers. Multiple persons are encouraged to view each registered connection (for example, by projecting the webinar in a conference room).
Registered persons will be sent an email the afternoon Friday, November 2, with the access information to join the webinar and the link to download and print a copy of the presentation slides.
Title: Finding Customers for Your Independent Consulting Practice
Presenter: Steve Simon
Date and Time: Wednesday, November 7, 2018, 12:00 p.m. – 1:30 p.m. Eastern time
Sponsor: Section on Statistical Consulting
Registration Deadline: Monday, November 5, at 12:00 p.m. Eastern time
If you want to set up your own consulting business, you need to get the word out to potential customers. There are traditional ways to do this, but there are also new ways of improving your visibility using social media. This webinar will compare and contrast the traditional approaches (such as giving talks and volunteering) to “old school” Internet (such as websites and email newsletters) to social media (such as Facebook and Twitter). The key to all three approaches is that you give away small samples of what you know for free to establish your credibility and build up a network of contacts.
Steve Simon received a Ph.D. in Statistics from the University of Iowa in 1982. He currently runs P.Mean Consulting as a sole proprietorship. He is also a part-time faculty member in the Department of Biomedical and Health Informatics at the University of Missouri-Kansas City. He has over 90 peer-reviewed publications, four of which have won major awards. He has written one book, Statistical Evidence in Medical Trials, and a book chapter, R for Big Data Analysis, in Big Data Analysis for Bioinformatics and Biomedical Discoveries. He is also is the author of a major website about Statistics, Research Design, and Evidence Based Medicine, www.pmean.com. One of his current areas of interest is using Bayesian models to forecast patient accrual in clinical trials.
Member of the Section on Statistical Consulting: $20
ASA Member: $65
Each registration is allowed one web connection and one audio connection. Multiple persons are encouraged to view each registered connection (for example, by projecting the webinar in a conference room).
Registered persons will be sent an email the afternoon of Monday, November 5, with the access information to join the webinar and the link to download and print a copy of the presentation slides.