Web-Based Lectures





Title: Use of Historical Data in Clinical Trial: An Evidence Synthesis Approach
Presenters: Satrajit Roychoudhury, Pfizer Inc and Sebastian Weber, Novartis Pharma AG
Date and Time: Wednesday, October 17, 2018, 12:00 p.m. – 2:00 p.m. Eastern time
Sponsor: Biopharmaceutical Section

Registration Deadline: Monday, October 15, at 12:00 p.m. Eastern time

Description:
A Bayesian approach provides the formal framework to incorporate external information into the statistical analysis of a clinical trial. There is an intrinsic interest of leveraging all available information for an efficient design and analysis of clinical trials. This allows trials with smaller sample size or with unequal randomization (more subjects on treatment than control). The use of external data in trials are nowadays used in earlier phases of drug development (Trippa, Rosnerand Muller, 2012; French, Thomas and Wang, 2012; Hueber et al., 2012), occasionally in phase III trials (French et al., 2012), and also in special areas such as medical devices (FDA, 2010a), orphan indications (Dupont and Van Wilder, 2011) and extrapolation in pediatric studies (Berry, 1989). Recently, 21st Century Cure Act and PUDUFA VI encourage the use of relevant historical data for efficient design. In this webinar we'll provide a statistical framework to incorporate trial external evidence with real life examples.

During the first part of the webinar we will introduce the meta-analytic predictive (MAP) model (Neuenschwander, 2010). The MAP model is a Bayesian hierarchical model which combines the evidence from different sources. MAP approach provides a prediction for the current study based on available information while accounting for inherent heterogeneity in the data. This approach can be used widely in different applications of clinical trial.

In the second part of the webinar we will focus on three key applications of the MAP approach in clinical trial. These applications will be demonstrated using the R package RBesT, the R Bayesian evidence synthesis tools, which are freely available from CRAN. The aim of the webinar is to teach the MAP approach and enable participants to apply the approach themselves with the help of RBesT.

Registration Fees:
Biopharmaceutical Section Members: $0
ASA Members: $59
Nonmembers: $74

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).

Registration is closed.

Access Information
Registered persons will be sent an email the afternoon of Monday, October 15, with the access information to join the webinar and the link to download and print a copy of the presentation slides.




Title: Pragmatic Benefit:Risk Evaluation: Using Outcomes to Analyze Patients Rather than Patients to Analyze Outcomes
Presenter: Scott Evans, PhD, MS, FIDSA
Date and Time: Thursday, October 18, 2018, 12:00 p.m. – 2:00 p.m. Eastern time
Sponsor: Biopharmaceutical Section

Registration Deadline: Tuesday, October 16, at 12:00 p.m. Eastern time

Description:
Randomized clinical trials are the gold standard for evaluating the benefits and risks of interventions. However these studies often fail to provide the necessary evidence to inform practical medical decision-making. The important implications of these deficiencies are largely absent from discourse in medical research communities.

Typical analyses of clinical trials involve intervention comparisons for each efficacy and safety outcome. Outcome-specific effects are tabulated and potentially systematically or unsystematically combined in benefit:risk analyses with the belief that such analyses inform the totality of effects on patients. However such approaches do not incorporate associations between outcomes of interest, suffer from competing risk challenges, and since efficacy and safety analyses are conducted on different analysis populations, the population to which these benefit:risk analyses apply, is unclear.

This deficit can be remedied with more thoughtful benefit:risk evaluation with a pragmatic focus in future clinical trials. Critical components of this vision include: (i) using outcomes to analyze patients rather than patients to analyze outcomes, (ii) incorporating patient values, and (iii) evaluating personalized effects. Crucial to this approach entails improved understanding of how to analyze one patient before analyzing many. Newly developed approaches to the design and analyses of trials such as partial credit and the desirability of outcome ranking (DOOR), are being implemented to more optimally inform patient treatment.

Registration Fees:
Biopharmaceutical Section Members: $0
ASA Members: $59
Nonmembers: $74

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).

Register

Access Information
Registered persons will be sent an email the afternoon of Tuesday, October 16, 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

Description:
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.

Bio:
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.

Registration Fees:
Member of the Section on Statistical Consulting: $20
ASA Member: $65
Nonmember: $85

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).

Register

Access Information
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.