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Updated: Apr 30, 2026

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Published on: April 11, 2016
Precision medicine clinical trials: defining new treatment strategies
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.
Insights
Clinical trials are evolving with new adaptive designs to personalize cancer care. These studies evaluate targeted therapies in specific patient groups, optimizing treatment delivery and identifying those most likely to benefit.
Area of Science:
- Oncology
- Clinical Trial Design
- Biomedical Technology
Background:
- Cancer care is shifting towards personalized treatment plans.
- Biomarker discovery and technological advancements are key drivers of this change.
- Traditional clinical trial models are being adapted to meet new challenges.
Purpose of the Study:
- To explore the role of clinical trials in personalized cancer care.
- To discuss innovative randomized studies evaluating targeted therapies.
- To highlight the integration of molecularly defined subsets in trial design.
Main Methods:
- Review of medical and nursing literature.
- Analysis of research articles.
- Inclusion of data from clinicaltrials.gov.
Main Results:
- Advancements in cancer biomarkers and technology are transforming cancer therapeutics.
- Innovative adaptive trial designs are emerging.
- Trials aim to determine not only safety and efficacy but also optimal delivery and patient benefit.
Conclusions:
- The cancer biomarker era necessitates specialized knowledge and skills for clinical trials.
- Understanding molecular processes and ethical considerations is crucial.
- Competent, safe, and effective healthcare requires expertise in biomarker-driven trials and patient communication.
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