scholarly journals Opportunities and Challenges for Drug Development: Public–Private Partnerships, Adaptive Designs and Big Data

2016 ◽  
Vol 7 ◽  
Author(s):  
Oktay Yildirim ◽  
Matthias Gottwald ◽  
Peter Schüler ◽  
Martin C. Michel
Keyword(s):  
Big Data ◽  
Drug Development ◽  
Adaptive Designs ◽  
Public Private Partnerships

scholarly journals Public private partnerships, big data networks and mitigation of information asymmetries

2017 ◽  
Vol 14 (4) ◽  
pp. 205-215 ◽  
Author(s):  
Roberto Moro Visconti
Keyword(s):  
Big Data ◽  
Public Private Partnerships ◽  
Data Networks ◽  
Information Asymmetries ◽  
Public And Private ◽  
Digital Platforms ◽  
Special Purpose Vehicle ◽  
Public And Private Stakeholders ◽  
Real Time Information ◽  
And Control

Public Private Partnerships (PPP) represent an increasingly frequent investment pattern where composite stakeholders interact in joint initiatives. Alignment of interests and consequent composition of conflicts is driven by the business purpose of the shared corporation, represented by a private Special Purpose Vehicle (SPV) within a Project Financing (PF) investment package. Corporate governance implications go beyond the traditional contraposition between ownership and control, showing cooperative patterns where the value is co-created and distributed. Big data-driven networks represent a trendy issue that connects public and private stakeholders through digital platforms where data are shared in real time. Information asymmetries and governance concerns are consequently softened.

scholarly journals Model-Assisted Designs for Early-Phase Clinical Trials: Simplicity Meets Superiority

2019 ◽  
pp. 1-12 ◽  
Author(s):  
Ying Yuan ◽  
J. Jack Lee ◽  
Susan G. Hilsenbeck
Keyword(s):  
Clinical Trials ◽  
Drug Development ◽  
Late Onset ◽  
Single Agent ◽  
Adaptive Designs ◽  
Superior Performance ◽  
Delayed Response ◽  
Phase I Clinical Trials ◽  
Phase Ii Trials ◽  
Major Barrier

Drug development enterprise is struggling because of prohibitively high costs and slow progress. There is urgent need for adoption of novel adaptive designs to improve the efficiency and success of clinical trials. A major barrier is that many conventional designs are inadequate for modern drug development, yet most novel adaptive designs are difficult to understand, require complicated statistical modeling, demand complex computation, and need expensive infrastructure for implementation. The objective of this article is to introduce and review a class of novel adaptive designs, known as model-assisted designs, to remove this barrier and increase the use of novel adaptive designs. Model-assisted designs enjoy superior performance comparable to more complicated, model-based adaptive designs, but their decision rule can be pretabulated and included in the protocol—thus implemented as simply as the conventional designs. We review state-of-the-art model-assisted designs for phase I clinical trials for single-agent, drug-combination and late-onset toxicity scenarios. We also briefly introduce model-assisted designs for phase II trials to handle binary, coprimary endpoints and delayed response. Freely available user-friendly software and trial examples (trialdesign.org) facilitate the adoption of model-assisted designs.

Applications of Adaptive Designs in Generic Drug Development

2020 ◽  
Author(s):  
Jieon Lee ◽  
Kairui Feng ◽  
Mingjiang Xu ◽  
Xiajing Gong ◽  
Wanjie Sun ◽  
...  
Keyword(s):  
Drug Development ◽  
Generic Drug ◽  
Adaptive Designs

scholarly journals Use of big data in drug development for precision medicine

2016 ◽  
Vol 1 (3) ◽  
pp. 245-253 ◽  
Author(s):  
Rosa S. Kim ◽  
Nicolas Goossens ◽  
Yujin Hoshida
Keyword(s):  
Big Data ◽  
Drug Development ◽  
Precision Medicine

Adaptive Designs in Clinical Drug Development—An Executive Summary of the PhRMA Working Group

2006 ◽  
Vol 16 (3) ◽  
pp. 275-283 ◽  
Author(s):  
Paul Gallo ◽  
Christy Chuang-Stein ◽  
Vladimir Dragalin ◽  
Brenda Gaydos ◽  
Michael Krams ◽  
...  
Keyword(s):  
Drug Development ◽  
Working Group ◽  
Adaptive Designs ◽  
Executive Summary ◽  
Clinical Drug Development ◽  
Clinical Drug
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