Adverse Experience Collection: Perspective from a Biological Development Program

Abstract

Differences in adverse experience reporting for biologic products and drugs include different regulatory bodies and a stronger emphasis with biologics on capturing data on potential allergic responses. Other considerations for collecting adverse experience data are common for biologics and drugs. Critical steps include: (1) planning prior to construction of case report forms, (2) education of nurse coordinators and investigators, and (3) monitoring to evaluate the effectiveness of instruction. Experience gained in the development of tissue plasminogen activator, a biologic product, resulted in the following specific recommendations for collection of adverse experience data: (1) instruct investigators to report syndromes rather than individual associated signs and symptoms, and (2) instruct investigators to distinguish primary adverse experiences from adverse experiences secondary to another adverse experience. In studies of critically ill patients where large volumes of adverse experiences are expected, collection of adverse experience data without forethought to strategies for data organization may obscure rather than reveal the true adverse experience profile.