Clinical Trials Safety Data

Patient safety monitoring is a critical component in the clinical development process. In the last few decades, the regulatory landscape has changed for safety data monitoring in clinical trials. The guidelines issued by regulatory authorities specifically for the collection of safety data during clinical trials, documentation, and reporting of serious adverse events have made a significant impact to ensure the safety of clinical trial subjects. The main objective of collecting and reporting safety data from clinical trials is early detection of important safety signals to protect subjects, provide information about new risks, assess the potential risk to future patients, and develop safety profile and product label of the drug contributing to its benefit–risk assessment throughout the life cycle of the product in clinical development.