alexa A New Adaptive Simon-Based Design Focusing on Subpopulation Heterogeneity
ISSN: 2169-0138

Drug Designing: Open Access
Open Access

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

A New Adaptive Simon-Based Design Focusing on Subpopulation Heterogeneity

Jacques Medioni1,2*, Caroline Tournoux-Facon3and Yann De4
1Department of Medical Oncology, Hôpital Européen Georges Pompidou, AP-HP, 20 rue Leblanc, 75015, Paris, France
2Paris Descartes University, Paris, France
3University Hospital-Pôle Régional de Cancérologie-CIC P802, 86000 Poitiers, France
4Epidemiology and Clinical Research Department, Hopital Bichat, 46 Rue Henri Huchard, 75018 Paris, France
*Corresponding Author : Jacques Medioni
Département d’Oncologie Médicale
Hôpital Européen Georges Pompidou
20, rue Leblanc, 75015 Paris, France
Tel: (33) 1 56 09 27 81
Fax: (33) 1 56 09 548
E-mail: [email protected]
Received November 21, 2015; Accepted March 04, 2016; Published March 11, 2016
Citation:Medioni J, Tournoux-Facon C, De Y (2016) A New Adaptive Simon- Based Design Focusing on Subpopulation Heterogeneity. Drug Des 5:128. doi: 10.4172/2169-0138.1000128
Copyright: © 2016 Medioni 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 credited.
 

Abstract

Background: Phase III trials can fail, leading to termination of drug development. This can result from heterogeneous subpopulations such as a drug-sensitive and a drug-insensitive subpopulation of patients or biological subtypes.

Methods: Traditional phase II methods do not detect heterogeneity of subpopulations. We proposed a new adaptive design for phase II trials, adapted from Simon’s “Minimax” design, where heterogeneity between two subpopulations could be highlighted.

Results: Drug inefficacy in one or two subpopulations could be determined at stage one and two and drug efficacy at stage two. Single Simon design and two independent Simon designs were compared to the adaptive design using calculated type I and II errors, expected and maximum sample size, and the probability of detecting drug-insensitive subpopulations. For the adaptive design, the type I and II errors calculated were similar to those of a single Simon design, sample size was smaller than with the two independent Simon designs (between 25 and 40% fewer patients) and the probability of detecting drug-insensitive subpopulations remained at 40%. An example with real data is presented.

Conclusion. In the event of different subpopulations of patients or biological subtypes, our adaptive design can help select the drug sensitive subpopulation in one single trial.

Keywords

Share This Page

Additional Info

Loading
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

Ronald

[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
adwords