Evaluating the risks and benefits of new brain treatments in early trials
The RATIOS Study: Risk/benefit AssessmenT by IRB review of Phase One Studies
This study is looking at how review boards make sure new treatments for brain disorders are safe and beneficial during early testing, and it aims to help patients understand what they might face by improving the information they receive before joining a trial.
Quick facts
| Grant type | R01 grant |
|---|---|
| Study type | NIH-funded research |
| Funding institution | University of California at Davis NIH-funded |
| Lab location | 1 site (Davis, United States) |
| Project ID | NIH-10754263 on NIH RePORTER |
What this research studies
This research investigates how Institutional Review Boards (IRBs) assess the risks and benefits of new treatments for neurological disorders during Phase 1 clinical trials. It focuses on improving the informed consent process by ensuring that patients receive clear and comprehensive information about potential risks and benefits. The study aims to identify reliable methods for evaluating preclinical efficacy data, especially for innovative techniques like CRISPR-Cas9 and brain organoids. By addressing the challenges faced by IRBs, the research seeks to enhance the ethical conduct of clinical trials and protect patient interests.
Who could benefit from this research
Good fit: Ideal candidates for this research are individuals considering participation in Phase 1 clinical trials for neurological conditions.
Not a fit: Patients with established neurological disorders who are not eligible for Phase 1 trials may not benefit from this research.
Why it matters
Potential benefit: If successful, this research could lead to safer and more effective treatments for patients with neurological disorders.
How similar studies have performed: While the ethical assessment of clinical trials is a well-explored area, this specific focus on novel preclinical techniques is relatively novel and has not been extensively tested.
Where this research is happening
Davis, United States
- University of California at Davis — Davis, United States (Active)
Researchers
- Principal investigator: Fedyk, Mark — University of California at Davis
- Study coordinator: Fedyk, Mark
About this research
- This is an active NIH-funded research project — typically early-stage science, not a clinical trial accepting patient enrollment.
- Some NIH-funded labs run parallel clinical studies or seek volunteers for related work. To check, contact the principal investigator or institution listed above.
- For full project details, budget, and progress reports, visit the official NIH RePORTER page below.