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National Academies of Sciences, Engineering, and Medicine; Health and Medicine Division; Board on Health Care Services; National Cancer Policy Forum. The Drug Development Paradigm in Oncology: Proceedings of a Workshop. Washington (DC): National Academies Press (US); 2017 Jul 24.

Cover of The Drug Development Paradigm in Oncology

The Drug Development Paradigm in Oncology: Proceedings of a Workshop.

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Acronyms and Abbreviations

ALK

amplastic lymphoma kinase

ASCO

American Society of Clinical Oncology

BATTLE-1

Biomarker-integrated Approaches of Targeted Therapy for Lung Cancer Elimination

CAP

College of American Pathologists

CDER

Center for Drug Evaluation and Research

CDK

cyclin-dependent kinases

CLIA

Clinical Laboratory Improvement Amendments of 1988

CMS

Centers for Medicare & Medicaid Services

CT

computed tomography

CY

cyclophosphamide

DOE

Department of Energy

DSMB

data and safety monitoring board

EGFR

epidermal growth factor receptor

EHR

electronic health record

EMA

European Medicines Agency

ER

estrogen receptor

FDA

Food and Drug Administration

FNIH

Foundation for the National Institutes of Health

HDAC

histone deacetylase

HER2

human epidermal growth factor receptor 2

HIPAA

Health Insurance Portability and Accountability Act

IND

investigational new drug

IRB

Institutional Review Board

I-SPY TRIAL

Investigation of Serial Studies to Predict Your Therapeutic Response with Imaging and Molecular Analysis

Lung-MAP

Lung Cancer Master Protocol

MRI

magnetic resonance imaging

NCI

National Cancer Institute

NCI-MATCH

National Cancer Institute-Molecular Analysis for Therapy Choice

NDA

New Drug Application

NGS

next-generation sequencing

OCE

Oncology Center of Excellence

OHOP

Office of Hematology and Oncology Products

ORR

overall response rate

OS

overall survival

PD-1

programmed death-1

PD-L1

programmed death-ligand 1

PERCIST

PET Response Criteria in Solid Tumors

PET

positron emission tomography

PFS

progression-free survival

POC

proof of concept

PRECIS

Pragmatic-Explanatory Continuum Indicator Summary

RECIST

Response Evaluation Criteria in Solid Tumors

START

South Texas Accelerated Research Therapeutics

TAPUR

Targeted Agent Profiling Utilization Registry Study

Copyright 2017 by the National Academy of Sciences. All rights reserved.
Bookshelf ID: NBK538017

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