What you should know about the ISS/ISE (ISR)
There are many reasons to integrate and to summarize all the data from a clinical trial program. Each clinical trial in the program is unique in its objective and design. Some are small safety studies among normal volunteers, while others are efficacy trials in a large patient population. The primary reason to create an integrated summary is to compare and to contrast all the various study results and to arrive at one consolidated review of the benefit/risk profile . A second and important reason is to reach a defensible statistical conclusion, through an exploration of the integrated data, that no competing alternative hypothesis that can reasonably account for the observed findings exists. Third, pooling the data from various studies enables the examination of trends in rare subgroups of patients, such as the elderly, those with differing disease states (mild vs. severe), and those with comorbidities at baseline. Last, providing such a summary in the new drug application is ...