The advisory committee provides crucial oversight to ensure scientific validity, participant safety, and ethical integrity in investigational drug studies.
Composition
Comprised of experts in fields like medicine, biostatistics, and ethics, who offer insights into clinical trial complexities.
Functions
Review Protocols: Evaluates study designs for scientific and ethical standards.
Monitor Progress: Periodically assesses data to ensure safety and integrity.
Recommendations: Advises on study amendments, continuation, or termination based on interim findings.
Ethical Oversight
Ensures participant rights and welfare are upheld throughout the study.
Transparency
Engages with the public to promote transparency in the drug approval process.