Group Sequential Tests for Delayed Responses Christopher Jennison Department of Mathematical Sciences University of Bath Lisa Hampson Department of Mathematics.

Slides:

Advertisements

Similar presentations

Patients’ Perspective on HTA and Off-label use David Head MBA Chief Executive RP Fighting Blindness 25th Annual EuroMeeting 4-6 March 2013 RAI, Amsterdam.

Advertisements

Data Monitoring Models and Adaptive Designs: Some Regulatory Experiences Sue-Jane Wang, Ph.D. Associate Director for Adaptive Design and Pharmacogenomics,

The Changing Face of Endpoint Security K Varadarajan Regional Manager, Enterprise Sales, Symantec Security Conference 2010_Bangalore.

© 2010 Pearson Education, Inc. All rights reserved.

Orphan Drugs: Where have we been; Where are we now; Where are we going Marlene E. Haffner, MD, MPH Haffner Associates, LLC 11 October,

Career Symposium Presentation for Middle School A Product of Creativity in Bloom Sal Anastasi 2010.

Clinical Trials in the Age of Personalized Cancer Medicine: The Evolution of a More Efficient, Patient Focused Clinical Research System Session Chair:

The Correct e- Mixtures (A fully validated EHR, the way forward) Brendan Delaney Guy’s and St Thomas’ Charity Chair in Primary Care Research.

FDA’s Biosimilars Guidance -- Legal and Regulatory Considerations James S. Cohen, Esq. McDermott Will & Emery DIA Webinar April 10, 2012.

Disclaimer The views and opinions expressed in the following PowerPoint slides are those of the individual presenter and should not be attributed to Drug.

Introduction to Drug Rediscovery John Lisman Attorney-at-law Lisman Legal Life sciences Insert your logo in this area then delete this text box.

How to audit the role of the vendor in the conduct of outsourced studies Kristel Van de Voorde Director Global Quality Regulatory Compliance Bristol-Myers.

Presenter Name Title Organization Twitter Handle Insert your logo here, then delete text.

Quick Thoughts on PGP Use Cases for KMIP 1 Michael Allen Sr. Technical Director.

1 “Something to put it in perspective…” Slide Show Name “Something to put it in perspective…” Presented by: Andy Lindsay Parallax, Inc.

Click to add Presentation Title Arial 32, 5 line max title space line 3, title space line 4, title space line 5 Presenter Title Organization Insert your.

© 2008 Verizon. All Rights Reserved. PTE /08 GLOBAL CAPABILITY. PERSONAL ACCOUNTABILITY. Verizon Instant Net Conference powered by Cisco-WebEx T26.

1 Optimal Strategies for Preparing Integrated and Clinical Summaries for a New Drug Application: Making it Work Under Any Circumstance Lisa A. Pierchala,

© 2014 Gartner, Inc. and/or its affiliates. All rights reserved. Gartner is a registered trademark of Gartner, Inc. or its affiliates. This publication.

Bayesian approach to equivalence study of medical device 1 1.

Date | Presenter Case Example: Bayesian Adaptive, Dose-Finding, Seamless Phase 2/3 Study of a Long-Acting Glucagon-Like Peptide-1 Analog (Dulaglutide)

Optimized Synthetics 1 OpenStorage Optimized Synthetics.

Sherri de Coronado Enterprise Vocabulary Services NCI Center for Bioinformatics and Information Technology March 11, 2009 A Terminology.

How to successfully Implement and Leverage the Regulatory Intelligence Function Marianne Koehne EU RI Network Group; Global RI Manager Boehringer Ingelheim.

Making Comments Count for High-Impact Regulations and Guidelines in the US Virginia (Ginny) Beakes-Read Executive Director, Global Regulatory Policy and.

Horst Kastrup September 8, 2015 The “T” in PETD.  The views and opinions expressed in the following PowerPoint slides are those of the individual presenter.

Strategic Analyses and Interpretation: Regulatory Intelligence for Decision Making Amy N. Grant Director, Regulatory Strategy & Science ViroPharma Incorporated.

Choosing the Right Writing Vendor(s) From the Perspective of the Pharma Company’s Medical Writing Manager.

Good Laboratory Practices and Inspection Readiness Paul Swidersky President/Sr. Consultant Quality Associates, Inc.

Meredith Brown-Tuttle, RAC Director APT Pharmaceuticals, Inc.

Draft White Paper “Protocol Deviations”

DIA ERS SIAC IND CMC eCTD Submissions Part II – IND to NDA

Process-based Metadata From a DIA Presentation: eTMF – Migrating from Paper Trial Master Files to Electronic Eldin Rammell, Managing Director, Rammell.

Experiences from building a lessons- learned database for regulatory interactions Åsa Rembratt Sr Reg Intelligence Manager Novo Nordisk A/S 26th Annual.

User Survey Responses: EDM Reference Model for Regulatory Submissions Antoinette Azevedo e-SubmissionsSolutions.com Core Team Member User Survey Co-Designer.

Making Comments Count for High-Impact Regulations and Guidelines in Canada, EU, Japan, and US Chairperson: Amy N. Grant Director, Regulatory Strategy &

Gabor Fari Life Sciences Solution Strategist Microsoft Corporation

Session Title Date ǀ Time

- A “Portable” Implementation

Mutagenic Impurities: Guidances Update w/ CMC Perspectives

Presenter Title Organization

Track 11 Symposium 27 June :30 – 3:00 PM

Clinical Trial Disclosure:

Perspective on GCP Warning Letters

Implementing a Successful Corrective and Preventative Action Program

Molly Butler Auditor II Quality Associates, Inc.

Interactive Session: Presentation of Scenarios and Q&A

Community-Based and Cluster-Randomized Studies –‘Pragmatic’ Approaches for Life Cycle Evidence? Florian Eichmann, PhD Principal Scientific Affairs and.

FirstPoint and FirstDoc Application of the DIA EDM Reference Model

Presenter Name Title Organization.

L.W. Cretschmar Española, S.A. (Spain)

Parallelspace PowerPoint Template for ArchiMate® 2.1 version 1.1

Parallelspace PowerPoint Template for ArchiMate® 2.1 version 2.0

1 Topic Title First slide 2 line 3 line 4 line

1 Topic Title First slide 2 line 3 line 4 line

PMI® Leadership Institute Meeting 2018―EMEA

PMI® EMEA Congress 2018 Session Title Session Date | Time

ე ვ ი ო Ш Е Т И О А С Д Ф К Ж З В Н М W Y U I O S D Z X C V B N M

Presenter Name Title Organization.

Disclaimer The views and opinions expressed in the following PowerPoint slides are those of the individual presenter and should not be attributed to Drug.

1 Session Title 2 line 3 line 4 line

ATTN Presenters – please review and remove this slide from your PowerPoint deck before uploading.

Session Title Date ǀ Time

1 Session Title 2 line 3 line 4 line

1 Topic Title First slide 2 line 3 line 4 line

1 Topic Title First slide 2 line 3 line 4 line

Dr. Ilona Große-Michaelis for the CIOMS MLG Exploratory Team

William W. Gregory for the CIOMS MLG Exploratory Team Pfizer Inc

SESSION TITLE Session # <insert number here> Date Month Year

SESSION TITLE Session #<insert number here> Date Month Year

Presentation transcript:

Group Sequential Tests for Delayed Responses Christopher Jennison Department of Mathematical Sciences University of Bath Lisa Hampson Department of Mathematics and Statistics University of Lancaster BfArM/DIA Statistics Workshop Bonn October 2012

The views and opinions expressed in the following PowerPoint slides are those of the individual presenter and should not be attributed to Drug Information Association, Inc. (“DIA”), its directors, officers, employees, volunteers, members, chapters, councils, Special Interest Area Communities or affiliates, or any organization with which the presenter is employed or affiliated. These PowerPoint slides are the intellectual property of the individual presenter and are protected under the copyright laws of the United States of America and other countries. Used by permission. All rights reserved. Drug Information Association, DIA and DIA logo are registered trademarks or trademarks of Drug Information Association Inc. All other trademarks are the property of their respective owners. Disclaimer 2www.diahome.orgDrug Information Association

Outline of talk Drug Information Associationwww.diahome.org3

1. Group sequential monitoring of clinical trials Drug Information Associationwww.diahome.org4

A group sequential test (GST) Drug Information Associationwww.diahome.org5

2. The problem of delayed responses Drug Information Associationwww.diahome.org6

The problem of delayed responses Drug Information Associationwww.diahome.org7

Short term information on “pipeline” subjects Drug Information Associationwww.diahome.org8

3. Defining a group sequential test with delayed responses Drug Information Associationwww.diahome.org9

Boundaries for a Delayed Response GST Drug Information Associationwww.diahome.org10

Calculations for a Delayed Response GST Drug Information Associationwww.diahome.org11

The value of information from pipeline subjects Drug Information Associationwww.diahome.org12

The value of information from pipeline subjects Drug Information Associationwww.diahome.org13

4. Optimising a Delayed Response GST Drug Information Associationwww.diahome.org14

Computing optimal Delayed Response GSTs Drug Information Associationwww.diahome.org15

An optimal design for the cholesterol example Drug Information Associationwww.diahome.org16

An optimal design for the cholesterol example Drug Information Associationwww.diahome.org17

An optimal design for the cholesterol example Drug Information Associationwww.diahome.org18

An optimal design for the cholesterol example Drug Information Associationwww.diahome.org 19

Efficiency loss when there is a delay in response Drug Information Associationwww.diahome.org20

5. Using a short term endpoint to recover efficiency Drug Information Associationwww.diahome.org21

Using a short term endpoint to recover efficiency Drug Information Associationwww.diahome.org22

Using a short term endpoint to recover efficiency Drug Information Associationwww.diahome.org23

Using a short term endpoint to recover efficiency Drug Information Associationwww.diahome.org24

6. Error spending Delayed Response GSTs Drug Information Associationwww.diahome.org25

The ρ-family of error spending functions Drug Information Associationwww.diahome.org26

7. Further topics Drug Information Associationwww.diahome.org27

Further topics Drug Information Associationwww.diahome.org28

Further topics Drug Information Associationwww.diahome.org29

Further topics Drug Information Associationwww.diahome.org30