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Revisiting Expectations in an Era of Precision Oncology
Emily J Marchiano1, Andrew C Birkeland1, Paul L Swiecicki2,3
1Department of Otolaryngology - Head and Neck Surgery, University of Michigan Medical School, Ann Arbor, Michigan, USA.
Abstract:
As we enter an era of precision medicine and targeted therapies in the treatment of metastatic cancer, we face new challenges for patients and providers alike as we establish clear guidelines, regulations, and strategies for implementation. At the crux of this challenge is the fact that patients with advanced cancer may have disproportionate expectations of personal benefit when participating in clinical trials designed to generate generalizable knowledge. Patient and physician goals of treatment may not align, and reconciliation of their disparate perceptions must be addressed. However, it is particularly challenging to manage a patient's expectations when the goal of precision medicine-personalized response-exacerbates our inability to predict outcomes for any individual patient. The precision medicine informed consent process must therefore directly address this issue. We are challenged to honestly, clearly, and compassionately engage a patient population in an informed consent process that is responsive to their vulnerability, as well as ever-evolving indications and evidence. This era requires a continual reassessment of expectations and goals from both sides of the bed.
Insights
Precision medicine in metastatic cancer requires clear guidelines. Managing patient expectations in clinical trials is crucial, as individual outcomes remain unpredictable despite personalized treatments.
Area of Science:
- Oncology
- Medical Ethics
- Clinical Trial Design
Background:
- The rise of precision medicine and targeted therapies presents new challenges in metastatic cancer care.
- Discrepancies between patient expectations for personal benefit and the generalizable knowledge goals of clinical trials are common.
- Aligning patient and physician treatment goals is essential but complicated by the unpredictable nature of personalized medicine.
Purpose of the Study:
- To highlight the challenges in establishing guidelines and strategies for precision medicine implementation in metastatic cancer.
- To address the critical need for managing patient expectations within the informed consent process for clinical trials.
- To emphasize the importance of honest, clear, and compassionate communication regarding treatment outcomes.
Main Methods:
- This study is a conceptual analysis and ethical discussion.
- It reviews the complexities of informed consent in the context of precision medicine.
- It synthesizes challenges faced by patients and healthcare providers.
Main Results:
- Precision medicine's goal of personalized response complicates outcome prediction for individual patients.
- The informed consent process must explicitly address the uncertainty of individual outcomes.
- Reconciling disparate patient and physician goals is a significant hurdle.
Conclusions:
- The informed consent process for precision medicine must be carefully tailored to patient vulnerability and evolving evidence.
- Continuous reassessment of expectations and goals by both patients and providers is necessary.
- Ethical implementation requires transparent communication about the limitations of predicting individual patient responses.
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