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Cited by 19Ethics in Clinical ResearchStatistical Methods in Clinical TrialsBiomedical Ethics and Regulation

Ethical considerations of neuro-oncology trial design in the era of precision medicine

Open access
Gupta, Saksham, Smith, Timothy R., Broekman, Marike L.·2017·Journal of Neuro-Oncology
DOI 10.1007/s11060-017-2502-0PMC PMC5543186
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Abstract

The field of oncology is currently undergoing a paradigm shift. Advances in the understanding of tumor biology and in tumor sequencing technology have contributed to the shift towards precision medicine, the therapeutic framework of targeting the individual oncogenic changes each tumor harbors. The success of precision medicine therapies, such as targeted kinase inhibitors and immunotherapies, in other cancers have motivated studies in brain cancers. The high specificity and cost of these therapies also encourage a shift in clinical trial design away from randomized control trials towards smaller, more exclusive early phase clinical trials. While these new trials advance the clinical application of increasingly precise and individualized therapies, their design brings ethical challenges . We review the pertinent ethical considerations for clinical trials of precision medicine in neuro-oncology and discuss methods to protect patients in this new era of trial design.

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  • The high specificity and costs of therapies mean that drugs are tested in smaller clinical trials rather than in large randomized controlled trials and even if several small trials have shown no risks, a level of uncertainty remains.

    “The high specificity and costs of therapies mean that drugs are tested in smaller clinical trials rather than in large randomized controlled trials and even if several small trials have shown no risks, a level of uncertainty remains [10].”

    From Patients’ and professionals’ views related to ethical issues in precision medicine: a mixed research synthesis (2021) · cites this paper as [10]

  • Avoiding telling patients about their genetic disposition for a treatable disease can also be harmful, as it deprives patients and their families of the opportunity for prevention and screening.

    “However, avoiding telling patients about their genetic disposition for a treatable disease can also be harmful, as it deprives patients and their families of the opportunity for prevention and screening [10].”

    From Patients’ and professionals’ views related to ethical issues in precision medicine: a mixed research synthesis (2021) · cites this paper as [10]

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Cited by

Sorted by citations

Authors
Gupta, S., Smith, T. R., & Broekman, M. L.
Affiliations
Brigham and Women's Hospital (US)
Corresponding author
Broekman, Marike L.
ORCID
Venue
Journal of Neuro-Oncology
Publisher
Springer Science and Business Media LLC
Published
2017-05-29
Volume
134
Issue
1
Pages
1-7
ISSN
  • 0167-594X (ISSN-L)
  • 1573-7373
DOI
10.1007/s11060-017-2502-0
PMC
PMC5543186
OpenAlex
W2617990204
Cited by
19
References
1
Citations by year
2026: 5 · 2025: 4 · 2024: 3 · 2022: 1 · 2021: 2 · 2019: 1 · 2018: 1 · 2017: 1 · 2016: 1
FWCI
0.13
Type
journal article
Language
en
Open access
Licence
Locations
  • Journal of Neuro-Oncology (publishedVersion, cc-by)
  • PubMed Central (publishedVersion, cc-by)
  • PubMed (publishedVersion)
  • Digital Access to Scholarship at Harvard (DASH) (Harvard University) (submittedVersion, cc-by)
Topics
  • Health Sciences › Medicine › Public Health, Environmental and Occupational Health › Ethics in Clinical Research
  • Physical Sciences › Mathematics › Statistics and Probability › Statistical Methods in Clinical Trials
  • Health Sciences › Nursing › Issues, ethics and legal aspects › Biomedical Ethics and Regulation
Keywords
neuro-oncology, clinical trial design, precision medicine, research ethics, brain tumors, targeted therapy, immunotherapy, patient protection, tumor sequencing
MeSH terms
Clinical Studies as Topic, Humans, Medical Oncology, Neoplasms, Neurology, Precision Medicine

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