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Introducing a Resource to Support Neonatal Nurse Engagement in Clinical Research ©
1Pediatric Clinical Development Research Consultant (self-employed).
Insights
A new resource supports neonatal nurses in clinical research, enhancing collaboration with pharmaceutical researchers to improve drug development for infants. This initiative aims to overcome challenges in neonatal therapy advancement.
Area of Science:
- Neonatal Medicine
- Clinical Research
- Nursing Science
Background:
- Neonates are underserved in drug development, leading to off-label medication use and impacting safety/efficacy evaluations.
- Neonatal Intensive Care Unit (NICU) nurses possess critical competencies for clinical trials but may lack research engagement experience.
Purpose of the Study:
- Introduce a resource to support neonatal nurse engagement in clinical research study design and protocol review.
- Promote collaboration between nurses and pharmaceutical researchers to advance neonatal therapies.
Main Methods:
- Resource development involved a comprehensive literature review.
- Usability testing was conducted with multiple stakeholders to refine the resource.
Main Results:
- Usability testing confirmed the resource is comprehensive and relevant for various study types.
- Feedback highlighted the resource's prompts as beneficial for assessing clinical trial feasibility.
Conclusions:
- Nurse engagement is crucial for improving clinical trial feasibility, flexibility, and preventing protocol deviations.
- Leveraging the resource enhances research education and nurse participation in neonatal studies.
- The resource benefits nurses, the nursing profession, and the pharmaceutical industry by fostering collaboration and advancing neonatal therapies.
Purpose:
This paper introduces the Resource to Support Neonatal Nurse Engagement in Clinical Research © to educate and support engagement of nurses in study design and protocol review. The resource serves to promote collaboration between nurses and pharmaceutical researchers to advance the development of neonatal therapies.
Background:
Neonates remain therapeutic orphans, underserved by the drug development community. Off-label use of drugs in neonates negatively impacts the evaluation of their safety and efficacy. Although NICU nurses' competencies are examples of expertise needed for well-designed clinical trials, nurses may have limited experience in providing insights.
Methods:
Resource development included a literature review and usability testing by multiple stakeholders.
Results:
Usability testing indicated the resource was comprehensive and relevant to pharmaceutical and nonpharmaceutical studies. Reviewers commented resource prompts are beneficial in assessing study feasibility.
Conclusion:
Sponsors of research need nurse engagement to improve feasibility and flexibility and prevent protocol deviations in clinical trials. Leveraging the "Resource to Support Neonatal Nurse Engagement in Clinical Research © " can enhance research education and foster engagement of nurses in neonatal research.
Implications For Practice:
The resource has implications for the nursing profession, the pharmaceutical industry, and the advancement of new therapies. Individual nurses benefit from education and a framework for research engagement. The profession benefits from enhanced visibility through research collaboration. The pharmaceutical industry gains valuable insights on neonatal care, family dynamics, and NICU standard of care. A resource to foster collaboration in the study development process is an important step for advancing new therapies for neonates.
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