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Review
. 2014 May;30(2):109-16.
doi: 10.1016/j.soncn.2014.03.004.

Precision medicine clinical trials: defining new treatment strategies

Brandy M Heckman-Stoddard, Judith J Smith
Review

Precision medicine clinical trials: defining new treatment strategies

Brandy M Heckman-Stoddard et al. Semin Oncol Nurs. 2014 May.

Abstract

Objectives: To discuss the role of clinical trials in the changing landscape of cancer care resulting in individualized cancer treatment plans including a discussion of several innovative randomized studies designed to evaluate multiple targeted therapies in molecularly defined subsets of individuals.

Data sources: Medical and nursing literature, research articles, and clinicaltrials.gov.

Conclusion: Recent advancements in cancer biomarkers and biomedical technology have begun to transform fundamentals of cancer therapeutics and clinical trials through innovative adaptive trial designs. The goal of these studies is to learn not only if a drug is safe and effective but also how it is best delivered and who will derive the most benefit.

Implications for nursing practice: Implementation of clinical trials in the cancer biomarker era requires knowledge, skills, and expertise related to the use of biomarkers and molecularly defined processes underlying a malignancy, as well as an understanding of associated ethical, legal, and social issues to provide competent, safe, and effective health care and patient communication.

Keywords: Precision medicine; adaptive design; biomarker; clinical trial; molecular targets; research ethics.

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Figures

FIGURE 1
FIGURE 1
I-SPY 2 Schema trial design for I-SPY 2 (investigation of serial studies to predict your therapeutic response with imaging and molecular analysis 2). HER2, human epidermal growth factor receptor 2; MRI, magnetic resonance imaging; AC, anthracycline (doxo-rubicin) and cyclophosphamide (Cytoxan).
FIGURE 2
FIGURE 2
Battle schema trial design for Biomarker-integrated Approaches of Targeted Therapy for Lung Cancer Elimination (BATTLE).
See this image and copyright information in PMC

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