What are the Challenges in Implementing ICH E9 in Cancer Research?
While ICH E9 provides a robust framework, its implementation can be challenging. Cancer trials often face issues such as heterogeneous patient populations, long follow-up periods, and complex endpoints. Researchers must be adept at adapting the guidelines to address these challenges without compromising the integrity of the trial. Additionally, the evolving nature of cancer treatment modalities requires continuous updates to trial designs and statistical methods.
