Speeding up the evaluation of new agents in cancer

Ann Marie Swart; Mahesh K B Parmar; Friederike M-S Barthel; Matthew Sydes; Ruth Langley; Rick Kaplan; Elizabeth Eisenhauer; Mark Brady; Nicholas James; Michael A Bookman; Wendi Qian; Patrick Royston

doi:10.1093/jnci/djn267

Speeding up the evaluation of new agents in cancer

Ann Marie Swart, Mahesh K B Parmar, Friederike M-S Barthel, Matthew Sydes, Ruth Langley, Rick Kaplan, Elizabeth Eisenhauer, Mark Brady, Nicholas James, Michael A Bookman, Wendi Qian, Patrick Royston

Research output: Contribution to journal › Article › peer-review

116 Citations (Scopus)

Abstract

Despite both the increase in basic biologic knowledge and the fact that many new agents have reached various stages of development during the last 10 years, the number of new treatments that have been approved for patients has not increased as expected. We propose the multi-arm, multi-stage trial design as a way to evaluate treatments faster and more efficiently than current standard trial designs. By using intermediate outcomes and testing a number of new agents (and combinations) simultaneously, the new design requires fewer patients. Three trials using this methodology are presented.

Original language	English
Pages (from-to)	1204-1214
Number of pages	11
Journal	Journal of the National Cancer Institute
Volume	100
Issue number	17
DOIs	https://doi.org/10.1093/jnci/djn267
Publication status	Published - 3 Sep 2008

Keywords

United States
Randomized Controlled Trials as Topic
Disease-Free Survival
Ovarian Neoplasms
Clinical Trials, Phase II as Topic
Antineoplastic Agents
Clinical Trials, Phase III as Topic
Humans
Clinical Trials as Topic
Research Design
Antibodies, Monoclonal
Neoplasms
United States Food and Drug Administration
Drug Approval
Treatment Outcome
Organoplatinum Compounds
Sample Size
Antibodies, Monoclonal, Humanized
Time Factors
Prostatic Neoplasms
Female
Male
Survival Analysis

UN SDGs

This output contributes to the following UN Sustainable Development Goals (SDGs)

Access to Document

10.1093/jnci/djn267

Cite this

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title = "Speeding up the evaluation of new agents in cancer",

abstract = "Despite both the increase in basic biologic knowledge and the fact that many new agents have reached various stages of development during the last 10 years, the number of new treatments that have been approved for patients has not increased as expected. We propose the multi-arm, multi-stage trial design as a way to evaluate treatments faster and more efficiently than current standard trial designs. By using intermediate outcomes and testing a number of new agents (and combinations) simultaneously, the new design requires fewer patients. Three trials using this methodology are presented.",

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T1 - Speeding up the evaluation of new agents in cancer

AU - Swart, Ann Marie

AU - Parmar, Mahesh K B

AU - Barthel, Friederike M-S

AU - Sydes, Matthew

AU - Langley, Ruth

AU - Kaplan, Rick

AU - Eisenhauer, Elizabeth

AU - Brady, Mark

AU - James, Nicholas

AU - Bookman, Michael A

AU - Qian, Wendi

AU - Royston, Patrick

PY - 2008/9/3

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N2 - Despite both the increase in basic biologic knowledge and the fact that many new agents have reached various stages of development during the last 10 years, the number of new treatments that have been approved for patients has not increased as expected. We propose the multi-arm, multi-stage trial design as a way to evaluate treatments faster and more efficiently than current standard trial designs. By using intermediate outcomes and testing a number of new agents (and combinations) simultaneously, the new design requires fewer patients. Three trials using this methodology are presented.

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KW - Humans

KW - Clinical Trials as Topic

KW - Research Design

KW - Antibodies, Monoclonal

KW - Neoplasms

KW - United States Food and Drug Administration

KW - Drug Approval

KW - Treatment Outcome

KW - Organoplatinum Compounds

KW - Sample Size

KW - Antibodies, Monoclonal, Humanized

KW - Time Factors

KW - Prostatic Neoplasms

KW - Female

KW - Male

KW - Survival Analysis

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JO - Journal of the National Cancer Institute

JF - Journal of the National Cancer Institute

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