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A quantitative process for enhancing end of phase 2 decisions

Sabin, T; Matcham, J; Bray, S; Copas, A; Parmar, MK; (2014) A quantitative process for enhancing end of phase 2 decisions. Statistics in Biopharmaceutical Research , 6 (1) 67 - 77. 10.1080/19466315.2013.852617. Green open access

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Abstract

The objectives of the phase 2 stage in a drug development program are to evaluate the safety and tolerability of different doses, select a promising dose range, and look for early signs of activity. At the end of phase 2, a decision to initiate phase 3 studies is made that involves the commitment of considerable resources. This multifactorial decision, generally made by balancing the current condition of a development organization's portfolio, the future cost of development, the competitive landscape, and the expected safety and efficacy benefits of a new therapy, needs to be a good one. In this article, we present a practical quantitative process that has been implemented for drugs entering phase 2 at Amgen Ltd. to ensure a consistent and explicit evidence-based approach is used to contribute to decisions for new drug candidates. Broadly following this process will also help statisticians increase their strategic influence in drug development programs. The process is illustrated using an example from the pancreatic cancer indication. Embedded within the process is a predominantly Bayesian approach to predicting the probability of efficacy success in a future (frequentist) phase 3 program.

Type: Article
Title: A quantitative process for enhancing end of phase 2 decisions
Open access status: An open access version is available from UCL Discovery
DOI: 10.1080/19466315.2013.852617
Publisher version: http://dx.doi.org/10.1080/19466315.2013.852617
Language: English
Additional information: © 2014 The Author(s). Published with license by American Statistical Association© Tony Sabin, James Matcham, Sarah Bray, Andrew Copas, Mahesh K. B. Parmar Statistics in Biopharmaceutical Research This is an Open Access article. Non-commercial re-use, distribution, and reproduction in any medium, provided the original work is properly attributed, cited, and is not altered, transformed, or built upon in any way, is permitted. The moral rights of the named author(s) have been asserted. Permission is granted subject to the terms of the License under which the work was published. Please check the License conditions for the work which you wish to reuse. Full and appropriate attribution must be given. This permission does not cover any third party copyrighted material which may appear in the work requested. PMCID: PMC3967501
Keywords: Decision making, Pancreatic cancer, Probability of success
UCL classification: UCL > Provost and Vice Provost Offices
UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences
UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences > Faculty of Pop Health Sciences > Inst of Clinical Trials and Methodology
UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences > Faculty of Pop Health Sciences > Inst of Clinical Trials and Methodology > MRC Clinical Trials Unit at UCL
UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences > Faculty of Pop Health Sciences > Institute for Global Health
UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences > Faculty of Pop Health Sciences > Institute for Global Health > Infection and Population Health
URI: https://discovery.ucl.ac.uk/id/eprint/1419171
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