alexa Finding Critical Values to Control Type I Error for a Biomarker Informed Two-Stage Winner Design
ISSN: 2155-6180

Journal of Biometrics & Biostatistics
Open Access

Like us on:
OMICS International organises 3000+ Global Conferenceseries Events every year across USA, Europe & Asia with support from 1000 more scientific Societies and Publishes 700+ Open Access Journals which contains over 50000 eminent personalities, reputed scientists as editorial board members.

Open Access Journals gaining more Readers and Citations

700 Journals and 15,000,000 Readers Each Journal is getting 25,000+ Readers

This Readership is 10 times more when compared to other Subscription Journals (Source: Google Analytics)

Research Article

Finding Critical Values to Control Type I Error for a Biomarker Informed Two-Stage Winner Design

Jing Wang1,2*, Sandeep Menon1,4 and Mark Chang1,3

1Department of Biostatistics, Boston University, 801 Massachusetts Avenue, Boston, MA 02118, USA

2Gilead Sciences, Inc. 303 Velocity Way, Foster City, CA 94404, USA

3AMAG Pharmaceuticals, Inc., 100 Hayden Avenue, Lexington, MA 02420, USA

4Pfizer, Inc., 35 Cambridge Park Drive, Cambridge, MA 02140, USA

*Corresponding Author:
Jing Wang
Gilead Sciences, Inc. 303 Velocity Way
Foster City, CA 94404, USA
Tel: 650-522-1167
E-mail: [email protected]

Received date: May 06, 2014; Accepted date: July 04, 2014; Published date: July 10, 2014

Citation: Wang J, Menon S, Chang M (2014) Finding Critical Values to Control Type I Error for a Biomarker Informed Two-Stage Winner Design. J Biomet Biostat 5:207. doi: 10.4172/2155-6180.1000207

Copyright: © 2014 Wang J, et al. This is an open-access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are are credited.



Adaptive clinical trial designs have been getting very popular in recent years. The PhRMA Working Group defines an adaptive design as a clinical study design that uses accumulating data to direct modification of aspects of the study as it continues, without undermining the validity and integrity of the [1]. These designs can assist in potentially accelerating clinical development and improving efficiency. However, the multiple interim looks and adaptive adjustments with the design can lead to inflation of type I error. Over the past decade, several statistical approaches have been proposed to control the inflation, some of which have been widely applied in practice. Some of these approaches include: error spending approach for classical group sequential plans [2-4]; Combination of p-values, such as Fisher’s combination test [5,6], Inverse Normal Method [7], sum of p-values approach [8]; conditional error function [9-11]; fixed weighting method [12]; variance spending method [13,14]; and multiple testing methodology such as closed test procedures [15-17].


Share This Page

Additional Info

Loading Please wait..
Peer Reviewed Journals
Make the best use of Scientific Research and information from our 700 + peer reviewed, Open Access Journals
International Conferences 2017-18
Meet Inspiring Speakers and Experts at our 3000+ Global Annual Meetings

Contact Us

Agri, Food, Aqua and Veterinary Science Journals

Dr. Krish

[email protected]

1-702-714-7001 Extn: 9040

Clinical and Biochemistry Journals

Datta A

[email protected]

1-702-714-7001Extn: 9037

Business & Management Journals


[email protected]

1-702-714-7001Extn: 9042

Chemical Engineering and Chemistry Journals

Gabriel Shaw

[email protected]

1-702-714-7001 Extn: 9040

Earth & Environmental Sciences

Katie Wilson

[email protected]

1-702-714-7001Extn: 9042

Engineering Journals

James Franklin

[email protected]

1-702-714-7001Extn: 9042

General Science and Health care Journals

Andrea Jason

[email protected]

1-702-714-7001Extn: 9043

Genetics and Molecular Biology Journals

Anna Melissa

[email protected]

1-702-714-7001 Extn: 9006

Immunology & Microbiology Journals

David Gorantl

[email protected]

1-702-714-7001Extn: 9014

Informatics Journals

Stephanie Skinner

[email protected]

1-702-714-7001Extn: 9039

Material Sciences Journals

Rachle Green

[email protected]

1-702-714-7001Extn: 9039

Mathematics and Physics Journals

Jim Willison

[email protected]

1-702-714-7001 Extn: 9042

Medical Journals

Nimmi Anna

[email protected]

1-702-714-7001 Extn: 9038

Neuroscience & Psychology Journals

Nathan T

[email protected]

1-702-714-7001Extn: 9041

Pharmaceutical Sciences Journals

John Behannon

[email protected]

1-702-714-7001Extn: 9007

Social & Political Science Journals

Steve Harry

[email protected]

1-702-714-7001 Extn: 9042

© 2008-2017 OMICS International - Open Access Publisher. Best viewed in Mozilla Firefox | Google Chrome | Above IE 7.0 version