Current Edition

Maximising the Role of Statisticians and Programmers to Reduce Timelines in Integrated Summaries of Safety and Effectiveness

An ISS is an Integrated Summary of Safety, and an ISE is an Integrated Summary of Effectiveness. An ISS combines the safety results from different studies conducted in a compound; while the ISE combines efficacy results. The regulatory authorities state both the ISS and ISE are critical components of a submission. David Underwood at Quanticate explains the combining of data in integrated summaries helps to address safety and efficacy concerns that are difficult to address using the data from individual trials.