How Does ICH Impact Clinical Trials in Gynecology?
The ICH provides a framework for the design, conduct, and reporting of clinical trials. Key guidelines include: - ICH E6 (R2) Good Clinical Practice: Ensures that clinical trials are ethically conducted and that data is credible. - ICH E8 General Considerations for Clinical Trials: Provides guidelines on the design and conduct of clinical trials, ensuring that they are scientifically valid and ethically sound. - ICH E9 Statistical Principles for Clinical Trials: Offers guidance on the statistical aspects of clinical trial design and analysis.
These guidelines are essential for ensuring that clinical trials in gynecology are conducted ethically and yield reliable data.
