How do regulations impact clinical trials for cancer therapies?
Clinical trials are tightly regulated to protect the safety and rights of participants. The FDA oversees clinical trials in the U.S., requiring Investigational New Drug (IND) applications before trials can begin. Institutional Review Boards (IRBs) must also approve and monitor trials, ensuring ethical standards are upheld. Additionally, trial protocols must comply with the International Conference on Harmonisation (ICH) Guidelines for Good Clinical Practice (GCP), which standardize the conduct of trials globally.
