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Compassionate use in research.
1Bellarmine University School of Nursing, Louisville, Kentucky 40223, USA. vmiracle@aol.com
Dimensions of Critical Care Nursing : DCCN
|February 20, 2009
Summary
Compassionate use provides investigational treatments for patients ineligible for clinical trials. Critical care nurses play a vital role in managing these complex patient cases.
Area of Science:
- Nursing
- Clinical Pharmacology
- Medical Ethics
Background:
- Critical care nurses frequently participate in clinical trials for novel medications, devices, and treatments.
- Patient eligibility for clinical trials is strictly defined by inclusion and exclusion criteria.
- Unresponsive conditions or failure to meet trial criteria may necessitate alternative treatment pathways.
Observation:
- Compassionate use, also known as expanded access, offers investigational therapies to patients outside of clinical trials.
- This pathway is considered when standard treatments are ineffective and the patient does not qualify for ongoing research.
- Navigating compassionate use requires understanding its definition, appropriate application, and approval processes.
Findings:
- The article defines compassionate use and outlines scenarios where it is deemed appropriate.
- It details the procedural aspects of obtaining approval for compassionate use.
- The essential role of critical care nurses in the care of patients receiving compassionate use treatments is highlighted.
Implications:
- Understanding compassionate use is crucial for critical care nurses managing complex patient populations.
- This knowledge empowers nurses to advocate for patients and facilitate access to potentially life-saving therapies.
- Effective management of compassionate use cases enhances patient care and supports the ethical expansion of treatment options.
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