What are the Key Considerations in Designing Human Trials?
Designing human trials involves several key considerations:
- Safety: Ensuring that the trial does not pose undue risk to participants. - Scientific Validity: Creating a robust study design that can produce reliable results. - Ethical Principles: Adhering to ethical guidelines to protect participants. - Informed Consent: Ensuring that participants are fully informed about the trial and voluntarily agree to participate. - Regulatory Compliance: Following guidelines set by regulatory authorities such as the FDA or EMA.
