What is the main focus of E6 in clinical trials?

The main focus of E6 in clinical trials is on providing a consolidated guidance for good clinical practices (GCP). This guideline, established by the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH), is fundamental in ensuring that clinical trials are conducted ethically and that the data collected is credible and reliable.

E6 outlines the responsibilities of sponsors, investigators, and institutional review boards, emphasizing the importance of protecting the rights, safety, and well-being of trial participants. By establishing standards for the conduct of clinical trials, E6 helps to ensure that the process is consistent across different regions and that the results can be trusted by regulatory authorities.

In contrast, statistical analysis, the design of protocols, and the writing of study reports, while important components of clinical research, are not the central focus of E6. These elements fall under the broader umbrella of clinical trial conduct but do not directly address the principles of good clinical practices that E6 aims to codify and promote.