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Innovation in the Design of Clinical Trials for Infectious Diseases: Focusing on Patients Over Pathogens
John H Powers1,2, Robert J O'Connell3
1Clinical Research Directorate, Frederick National Laboratory for Cancer Research, Frederick, MD, USA. powersjohn@mail.nih.gov.
Current infectious disease research, focusing on in vitro drug activity, often fails to improve patient outcomes. A shift towards patient-centered research is crucial for better clinical evidence and effective treatments.
Area of Science:
- Infectious disease research
- Clinical microbiology
- Translational medicine
Background:
- In vitro antimicrobial susceptibility testing does not fully predict clinical outcomes.
- Suboptimal patient outcomes persist despite in vitro drug susceptibility.
- Current research paradigms overlook the immune system's role and real-world clinical questions.
Purpose of the Study:
- To advocate for a paradigm shift in infectious disease research.
- To emphasize the need for research focused on improving patient outcomes.
- To highlight the limitations of current in vitro-centric approaches.
Main Methods:
- Critically analyze current infectious disease research methodologies.
- Identify the disconnect between laboratory findings and clinical practice.
- Propose changes in research questions, patient selection, interventions, and outcome evaluation.
Main Results:
- Current research often fails to address critical clinical questions.
- Focusing solely on in vitro susceptibility is insufficient for improving patient care.
- A shift in research focus is necessary to generate clinically relevant evidence.
Conclusions:
- Infectious disease research must prioritize patient outcomes over in vitro activity.
- Reorienting research will lead to better evidence for patient care.
- This shift will better justify the development and payment of new interventions.
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