-
Small Pharma Advanced Safety Analytics Proof Points
Large pharma, small pharma- same regulations, suprisingly different approaches and needs. As a consultant, I specialize in helping small pharma easily, efficiently, and affordably incorporate advanced safety analytics that serve a far greater purpose than simply regulatory compliance: investor due dilligence. Recently, a small pharma successfully sold a pre-market asset to a large pharma in…
-
The ASAP Process supports the Safety Surveillance Plan
The 2021 IND safety reporting guidance highlights the importance of maintaining a Safety Surveillance Plan (SSP) that describes the approach for monitoring serious anticipated events requiring aggregate analysis. Decisionmaking for this approach needs to be supported by an ongoing systematic assessment of the product’s safety data from all sources. The Aggregate Safety Assessment Planning (ASAP)…
-
A Learning and Decision Making Approach
A Learning and Decision-Making Approach PhRMA SPERT proposed three tiers (classifying endpoints by analysis) for analyzing AEs. An alternative approach is to think of two parts (classifying endpoints by clinical interest) for assessing AEs and other safety data. On the surface this may appear to be a subtle difference; however, it fundamentally transforms a testing…
-
The ASAP Process Builds on CIOMS VI and the PSAP
In 2005, CIOMS VI (Management of Safety Information from Clinical Trials) started to bridge the gap between pre- and post-approval activities to understand and manage risk. Pharmacovigilance had traditionally focused on detection and evaluation of signals in the post-approval environment to secure early detection of new adverse reactions or high risk subgroups, and to introduce…
-
Regaining Global Alignment on Safety Reporting from Clinical Trials
EU regulators prefer to receive all individual SUSAR reports from sponsors (judged by sponsor and/or investigator) – concerned about missing important signals. Note, Reference Safety Information (RSI) listed in the Investigator’s Brochure, which forms the basis for the expectedness assessment of all “suspected” SARs that occur in clinical trials, requires aggregate assessments based on SPONSOR…
-
Global Regulatory Landscape for Aggregate Safety Assessments
Recent guidance on safety monitoring during drug development, issued by regulatory authorities in the US and EU, indicate a shift in focus toward aggregate safety monitoring and scientific evaluation of integrated safety data earlier in the development program. This shift in emphasis provides an opportunity for sponsors to engage in the advancement of cross disciplinary…