The Use of Clinical Utility Assessments in Early Clinical Development

被引:0
作者
Anis A. Khan
Itay Perlstein
Rajesh Krishna
机构
[1] Merck Research Laboratories,Quantitative Clinical Pharmacology, Department of Clinical Pharmacology
[2] Merck & Co.,undefined
[3] Inc.,undefined
来源
The AAPS Journal | 2009年 / 11卷
关键词
clinical utility index; modeling and simulation; therapeutic index;
D O I
暂无
中图分类号
学科分类号
摘要
A quickly realizable benefit of model-based drug development is in reducing uncertainty in risk/benefit, comprising individually of safety and effectiveness, two key attributes of a product evaluated for regulatory approval, marketing, and use. In this review, we investigate gaps and opportunities in using fundamental decision analytic principles in drug development and present a quantitative clinical pharmacology framework for the application of such aids for early clinical development decision making. We anticipate that implementation of such emerging tools will enable sufficient scientific understanding of the two attributes to facilitate the early termination of compounds with less than desirable risk/benefit profiles and continuance of compounds with acceptable risk/benefit profiles.
引用
收藏
页码:33 / 38
页数:5
相关论文
共 50 条
[21]   Advances in clinical trials technologies [J].
Jang, In-Jin .
JOURNAL OF THE KOREAN MEDICAL ASSOCIATION, 2010, 53 (09) :761-768
[22]   Postmarketing Assessment of Antibody-Drug Conjugates: Proof-of-Concept Using Model-Based Meta-Analysis and a Clinical Utility Index Approach [J].
Asiimwe, Innocent Gerald ;
Chtiba, Nour ;
Mouksassi, Samer ;
Pillai, Goonaseelan ;
Peter, Raimund M. ;
Yuen, Eunice ;
Pilla Reddy, Venkatesh .
CPT-PHARMACOMETRICS & SYSTEMS PHARMACOLOGY, 2025,
[23]   Use of a dose-response model to guide future clinical trials of benvitimod cream to treat mild and moderate psoriasis [J].
Zang, Yan-Nan ;
Jiang, Dao-Li ;
Cai, Lin ;
Chen, Xin ;
Wang, Qian ;
Xie, Zhen-Wei ;
Liu, Yang ;
Zhang, Chun-Yan ;
Jing, Shan ;
Chen, Gen-Hui ;
Zhang, Jian-Zhong ;
Xu, Ling ;
Feng, Wan-Yu ;
Zhao, Li-Bo ;
Fang, Yi .
INTERNATIONAL JOURNAL OF CLINICAL PHARMACOLOGY AND THERAPEUTICS, 2016, 54 (02) :87-95
[24]   Two-stage model-based clinical trial design to optimize phase I development of novel anticancer agents [J].
Anthe S. Zandvliet ;
Mats O. Karlsson ;
Jan H. M. Schellens ;
William Copalu ;
Jos H. Beijnen ;
Alwin D. R. Huitema .
Investigational New Drugs, 2010, 28 :61-75
[25]   Model-Informed Drug Development for Long-Acting Injectable Products: Summary of American College of Clinical Pharmacology Symposium [J].
Sharan, Satish ;
Fang, Lanyan ;
Lukacova, Viera ;
Chen, Xiaomei ;
Hooker, Andrew C. ;
Karlsson, Mats O. .
CLINICAL PHARMACOLOGY IN DRUG DEVELOPMENT, 2021, 10 (03) :220-228
[26]   Two-stage model-based clinical trial design to optimize phase I development of novel anticancer agents [J].
Zandvliet, Anthe S. ;
Karlsson, Mats O. ;
Schellens, Jan H. M. ;
Copalu, William ;
Beijnen, Jos H. ;
Huitema, Alwin D. R. .
INVESTIGATIONAL NEW DRUGS, 2010, 28 (01) :61-75
[27]   Innovative Thinking on Endpoint Selection in Clinical Trials [J].
Chow, Shein-Chung ;
Huang, Zhipeng .
JOURNAL OF BIOPHARMACEUTICAL STATISTICS, 2019, 29 (05) :941-951
[28]   Advancing clinical trial design in pulmonary hypertension [J].
Grieve, Andy P. ;
Chow, Shien-Chung ;
Curram, John ;
Dawe, Stephen ;
Harnisch, Lutz O. ;
Henig, Noreen R. ;
Hung, Hsien Ming J. ;
Ivy, D. Dunbar ;
Kawut, Steven M. ;
Rahbar, Mohammad H. ;
Xiao, Shen ;
Wilkins, Martin R. .
PULMONARY CIRCULATION, 2013, 3 (01) :217-225
[29]   Comparing oncology clinical programs by use of innovative designs and expected net present value optimization: Which adaptive approach leads to the best result? [J].
Parke, Tom ;
Marchenko, Olga ;
Anisimov, Vladimir ;
Ivanova, Anastasia ;
Jennison, Christopher ;
Perevozskaya, Inna ;
Song, Guochen .
JOURNAL OF BIOPHARMACEUTICAL STATISTICS, 2017, 27 (03) :457-476
[30]   Patient Adherence: Clinical Pharmacology's Embarrassing Relative [J].
Fossler, Michael J. .
JOURNAL OF CLINICAL PHARMACOLOGY, 2015, 55 (04) :365-367