ASA Biopharmaceutical Section: Workshops

Non-Parametric Dose Response Models in Bayesian Adaptive Designs
Andrew P. Grieve (School of Medicine, King's College)
Thursday, February 18, noon - 2:00 p.m. Eastern time
Registration Deadline: Friday, February 12

There has been considerable recent interest in pharmaceutical R&D in the use of flexible, non-monotonic dose-response models. Two examples of this are the ASTIN study (Krams et al, STROKE, 2003;34:2543-2548) and a proof-of-concept study in neuropathic pain (Smith et al, PHARMACEUTICAL STATISTICS, 2006;5:39-50) both of which used a flexible dose-response function based on the Normal Dynamic Linear Model (NDLM), a model whose origins are in time series. This model is potentially very important since the work of the Pharma Working Group on Adaptive Dose-ranging Designs White paper of the PhRMA PISC working group on adaptivedose-ranging designs. (Bornkamp et al, J. BIOPHARMACEUTICAL STATISTICS, 2007;17:965-995).indicated that a Bayesian adaptive design utilising the model outperformed alternative approaches. There are, however, other possibilities including splines and kernel regression. Up to now the use of this type of model has required tailor made programs of suites of programs. In this talk I show how the different approaches are related to one another and how there are particular advantages in using one form over another and how recent research
opens up different ways of fitting these models.

Registered attendees will be emailed the access information for the webinar on Monday, February 16.

Data Monitoring in Practice: Making Your Data Monitoring Committee Effective
Janet Wittes & Matt Downs (Statistics Collaborative, Inc., Washington DC)
Wednesday, March 10, noon - 2:00 p.m. Eastern time
Registration Deadline: Friday, March 5

Many randomized clinical trials include a data monitoring committee (DMC) that is responsible for reviewing accruing data, monitoring performance of the trial, assuring safety of the participants in the trial, and assessing the efficacy of treatment. The DMC often makes recommendations about continuation of the trial or alteration of the protocol. This webinar will provide a practical overview of the role and functioning of DMCs. Specifically, we will discuss the Committee's responsibilities: We will discuss when a DMC is needed, what its charter should include, and how its meeting should run. We will also focus on some controversies surrounding DMCs: for example, how to define 'independence', who should present data to the DMC, whether the DMC should be masked or unmasked, and how the DMC should communicate its recommendations. Finally, we will address some practical issues faced by industry in setting up and managing a DMC. We will discuss such topics as how to schedule meetings, who should program the tables, what the DMC's report should include, and how to ensure that data are sufficiently current to allow the DMC to make timely relevant recommendations.

Registered attendees will be emailed the access information for the webinar on Monday, March 8.

About Webinars

A webinar is a seminar which is conducted over the World Wide Web. It is a type of web conferencing. In contrast to a Webcast, which is transmission of information in one direction only, webinars are designed to be interactive between the presenter and audience. A webinar is 'live' in the sense that information is conveyed according to an agenda, with a starting and ending time. In the case of the Biopharmaceutical Section Webinar Series, the presenter speaks over a standard telephone line, pointing out information being presented on screen. The audience receives the audio of the presentation via telephone call-in number of audio streaming over the internet. The audience can respond via a chat feature. The word 'webinar' is a blend of web and seminar.

Attendee User Guide

System Requirements

Operating System: Windows 2000 to present, Macintosh OSX, Linux Redhat
Browser: Internet Explorer (IE) 5.5+, Firefox 2.0+, Opera 9.0+, Mozilla 1.71+, Safari 3.1
Other: Events with streaming audio or video require Macromedia Flash 8.0+
Hardware: 56Kbps Internet access. Speakers or headphones and cable modem, DSL, ISDN, or equivalent broadband needed to receive audio/video streaming (128K minimum).

*Opera browser will not allow access to the Question and Answer feature of the console.

More information on the Web-based training program can be found at the biopharmaceutical network's web site.

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Last Updated 01-29-07	.
	a m e r i c a n s t a t i s t i c a l a s s o c i a t i o n
	Biopharmaceutical Section Web-based Training Series Registration Fees: Member of the Biopharmaceutical Section: $44 ASA Member: $59 Nonmember: $74 Each registration is allowed one web connection and one audio connection. The Biopharmaceutical Section encourages multiple persons to view each registered connection (for example, by projecting the webinar in a conference room). Current Offerings: Non-Parametric Dose Response Models in Bayesian Adaptive Designs Andrew P. Grieve (School of Medicine, King's College) Thursday, February 18, noon - 2:00 p.m. Eastern time Registration Deadline: Friday, February 12 There has been considerable recent interest in pharmaceutical R&D in the use of flexible, non-monotonic dose-response models. Two examples of this are the ASTIN study (Krams et al, STROKE, 2003;34:2543-2548) and a proof-of-concept study in neuropathic pain (Smith et al, PHARMACEUTICAL STATISTICS, 2006;5:39-50) both of which used a flexible dose-response function based on the Normal Dynamic Linear Model (NDLM), a model whose origins are in time series. This model is potentially very important since the work of the Pharma Working Group on Adaptive Dose-ranging Designs White paper of the PhRMA PISC working group on adaptivedose-ranging designs. (Bornkamp et al, J. BIOPHARMACEUTICAL STATISTICS, 2007;17:965-995).indicated that a Bayesian adaptive design utilising the model outperformed alternative approaches. There are, however, other possibilities including splines and kernel regression. Up to now the use of this type of model has required tailor made programs of suites of programs. In this talk I show how the different approaches are related to one another and how there are particular advantages in using one form over another and how recent research opens up different ways of fitting these models. Registered attendees will be emailed the access information for the webinar on Monday, February 16. Data Monitoring in Practice: Making Your Data Monitoring Committee Effective Janet Wittes & Matt Downs (Statistics Collaborative, Inc., Washington DC) Wednesday, March 10, noon - 2:00 p.m. Eastern time Registration Deadline: Friday, March 5 Many randomized clinical trials include a data monitoring committee (DMC) that is responsible for reviewing accruing data, monitoring performance of the trial, assuring safety of the participants in the trial, and assessing the efficacy of treatment. The DMC often makes recommendations about continuation of the trial or alteration of the protocol. This webinar will provide a practical overview of the role and functioning of DMCs. Specifically, we will discuss the Committee's responsibilities: We will discuss when a DMC is needed, what its charter should include, and how its meeting should run. We will also focus on some controversies surrounding DMCs: for example, how to define 'independence', who should present data to the DMC, whether the DMC should be masked or unmasked, and how the DMC should communicate its recommendations. Finally, we will address some practical issues faced by industry in setting up and managing a DMC. We will discuss such topics as how to schedule meetings, who should program the tables, what the DMC's report should include, and how to ensure that data are sufficiently current to allow the DMC to make timely relevant recommendations. Registered attendees will be emailed the access information for the webinar on Monday, March 8. About Webinars A webinar is a seminar which is conducted over the World Wide Web. It is a type of web conferencing. In contrast to a Webcast, which is transmission of information in one direction only, webinars are designed to be interactive between the presenter and audience. A webinar is 'live' in the sense that information is conveyed according to an agenda, with a starting and ending time. In the case of the Biopharmaceutical Section Webinar Series, the presenter speaks over a standard telephone line, pointing out information being presented on screen. The audience receives the audio of the presentation via telephone call-in number of audio streaming over the internet. The audience can respond via a chat feature. The word 'webinar' is a blend of web and seminar. Attendee User Guide System Requirements Operating System: Windows 2000 to present, Macintosh OSX, Linux Redhat Browser: Internet Explorer (IE) 5.5+, Firefox 2.0+, Opera 9.0+, Mozilla 1.71+, Safari 3.1 Other: Events with streaming audio or video require Macromedia Flash 8.0+ Hardware: 56Kbps Internet access. Speakers or headphones and cable modem, DSL, ISDN, or equivalent broadband needed to receive audio/video streaming (128K minimum). *Opera browser will not allow access to the Question and Answer feature of the console. More information on the Web-based training program can be found at the biopharmaceutical network's web site. << HOME \|\| ASA HOMEPAGE \|\| CHARTER \|\| OPERATIONS MANUAL \|\| EXECUTIVE COMMITTEE MEMBERSHIP \|\| BIOPHARM REPORT \|\| AWARDS \|\| MORE INFO \|\| PAST ACTIVITIES \|\| FEEDBACK