Monitoring of Safety and Effectiveness of COVID-19 Therapeutics: Aim 1 Protocol Development

Sequential surveillance of therapeutics in electronic health data enables routine monitoring for a statistically significant increased risk of specific adverse events. When performing sequential surveillance of drug safety, a formal study is designed and repeated as data accrues to identify any increased risk for outcomes of interest as quickly as possible. This monitoring is continued until 1) there are findings that indicate that a safety issue may be present and therefore more follow-up or a regulatory action is warranted, or 2) until findings provide assurance that the safety issue of interest does not require further action.

The Sentinel System has integrated the capability to perform sequential surveillance into its routine analytic tools. The tools have the ability to perform multiple executions of cohort or self-controlled risk interval analyses. This project aims to leverage these capabilities to assist FDA in their response to the COVID-19 pandemic – specifically monitoring safety of new therapeutics. A master protocol will be designed such that it can be leveraged to proactively monitor the safety of these therapeutics as they undergo FDA review and are introduced to the market. 

The Sentinel Operations Center has posted this final draft protocol for public comment. Comments must be received by the Sentinel Operations Center no later than December 1, 2023.

Submit comments by sending an email directly to info@sentinelsystem.org. Please include the following information along with your comments:

• Protocol title
• Section(s) and page number(s) of protocol, if appropriate
• Optional (but preferred):
  • Your name
  • Your organization and title
  • Your email address

The workgroup will consider all comments, but under most circumstances will not reply directly to commenters.

Any revisions done to this surveillance plan/protocol after it is posted for public comment will be noted in the change log document posted along with the amended surveillance plan/protocol. Posting of both documents will be listed on the Sentinel homepage, on the relevant assessments project details page, and in the Sentinel RSS feed.