Journal for Clinical Studies
Sept 2013; Volume 5 Issue 5
Chitra Lele, Suhasini Sharma, Darshan Bhatt at Sciformix
Capture and management of safety data are critical components of the clinical trial (CT) process. In addition to ensuring safety of CT participants, systematic capture and analysis of safety data from CTs is important for developing the safety profile of the drug and contributing to its benefit-risk assessment, which is a key consideration in the approval decision. During the pre-approval CTs (Phase I – III) the safety profile of the drug is largely unknown.
The objectives of collecting safety data from CTs are early detection of important safety signals, protecting patients from unnecessary risks, and developing a safety profile of the drug, contributing to its benefit-risk assessment. Safety data from ongoing CTs influences the clinical care of patients enrolled in these and other trials. The ultimate goal is to evolve medically useful safety label information, and to ensure that safety data generated during clinical
development can be seamlessly merged with post-marketing data to develop a comprehensive safety profile for the product over a reasonable timeframe.