Safety Reporting from Clinincal Trials: What Regulators Expect

Clinical Trials Yearbook, December 2013

By:  Suhasini Sharma, Darshan Bhatt, Chitra Lele

Monitoring patient safety is an integral and critical part of the clinical trial process. The objective of collecting safety data from clinical trials is early detection of important safety signals, protecting patients from unnecessary risks, and developing the safety profile of the drug contributing to its benefit-risk assessment. Safety data from ongoing clinical trials has a direct impact on the safety and clinical care of patients enrolled in these trials. The ultimate goal of clinical trial safety monitoring is to evolve medically relevant safety label information for the product under development. Mandates by regulatory authorities around the documentation and reporting of serious events have evolved significantly to help ensure the safety of clinical trial subjects.

The regulatory landscape for safety monitoring of healthcare products has changed considerably in recent years.

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