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Activity Number: 548
Type: Contributed
Date/Time: Wednesday, August 3, 2016 : 10:30 AM to 12:20 PM
Sponsor: Biopharmaceutical Section
Abstract #321520
Title: Collection of Adverse Events Data for the Supplemental Indications in Cancer Clinical Trials: Is It Needed?
Author(s): Sirisha Mushti* and Huanyu Chen and Yun Wang and Rajeshwari Sridhara
Companies: FDA and FDA and FDA and FDA
Keywords: Supplemental indications ; safety data
Abstract:

Safety data collected for supplemental indications (SI) is usually similar to the safety data collected in support of the initial approval of the agent. It is unknown if comprehensive collection of safety data for SI adds any new information to the existing safety profile of the drug. In order to examine the redundancy in collecting exhaustive safety data in SI, we reviewed product labels of 14 approved drugs that had SI. Data, based on randomized clinical trials, from product labels of original and SI were collected to study the AE profiles. For each of the drugs, the number of unique AEs with >5% difference in the incidence of AE rates between the treatment and control arm were identified. Data was then summarized into either: - observed only in original but not in SI or - not observed in the original submissions but in SI. Based on the number of new AEs that were reported in the product label for SI, it could be inferred that the safety data from the SI, in addition to the reported AEs in original indication widened the AE profile for the drug. Collecting comprehensive safety data for supplemental indications can be useful in characterizing the safety profile of cancer agents.


Authors who are presenting talks have a * after their name.

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