PMID- 37072647
OWN - NLM
STAT- MEDLINE
DCOM- 20230531
LR  - 20230531
IS  - 1179-1993 (Electronic)
IS  - 1178-2595 (Linking)
VI  - 37
IP  - 3
DP  - 2023 May
TI  - Value and Implementation of the Aggregate Safety Assessment Plan.
PG  - 171-181
LID - 10.1007/s40290-023-00470-2 [doi]
AB  - Aggregate safety assessment involves evaluation of the totality of safety data to 
      characterize the emerging safety profile of a product. The Drug Information 
      Association-American Statistical Association Interdisciplinary Safety Evaluation 
      scientific working group recently published an approach to developing an 
      Aggregate Safety Assessment Plan (ASAP). Creation of an ASAP facilitates a 
      consistent approach to safety data collection and analysis across studies and 
      minimizes important missing data at the time of regulatory submission. A critical 
      aspect of the ASAP is identification of the Safety Topics of Interest (STOI). The 
      STOI, as defined in the ASAP, comprises adverse events (AEs), which have the 
      potential to impact the benefit: risk profile of a product and typically require 
      specialized data collection or analyses. While there are clear benefits to 
      developing an ASAP for a drug development program, multiple concerns may be 
      encountered with implementation. This article uses the examples of two STOIs to 
      demonstrate the benefits and efficiencies gained with implementation of the ASAP 
      in safety planning as well as in optimally characterizing the emerging safety 
      profile of a product.
CI  - (c) 2023. The Author(s), under exclusive licence to Springer Nature Switzerland AG.
FAU - Hendrickson, Barbara A
AU  - Hendrickson BA
AUID- ORCID: 0000-0002-8722-3455
AD  - University of Chicago, Chicago, IL, 60637, USA. bhendric@bsd.uchicago.edu.
FAU - Agarwal, Anupam
AU  - Agarwal A
AD  - Denovo Biopharma, San Diego, CA, USA.
FAU - Bennett, Dimitri
AU  - Bennett D
AD  - Takeda Development Center Americas, Inc., Global Evidence and Outcomes, 
      Cambridge, MA, USA.
FAU - Kubler, Jurgen
AU  - Kubler J
AD  - QSciCon, Quantitative Scientific Consulting, Marburg, Germany.
FAU - McShea, Cynthia
AU  - McShea C
AD  - UCB Biosciences, Statistical Science and Innovation, Morrisville, NC, USA.
FAU - Tremmel, Lothar
AU  - Tremmel L
AD  - CSL Behring, Quantitative Clinical Sciences and Reporting, King of Prussia, PA, 
      USA.
LA  - eng
PT  - Journal Article
DEP - 20230419
PL  - New Zealand
TA  - Pharmaceut Med
JT  - Pharmaceutical medicine
JID - 101471195
SB  - IM
MH  - *Data Collection/methods
MH  - United States
MH  - *Adverse Drug Reaction Reporting Systems/organization & administration
EDAT- 2023/04/19 00:42
MHDA- 2023/05/25 06:42
CRDT- 2023/04/18 23:31
PHST- 2023/03/09 00:00 [accepted]
PHST- 2023/05/25 06:42 [medline]
PHST- 2023/04/19 00:42 [pubmed]
PHST- 2023/04/18 23:31 [entrez]
AID - 10.1007/s40290-023-00470-2 [pii]
AID - 10.1007/s40290-023-00470-2 [doi]
PST - ppublish
SO  - Pharmaceut Med. 2023 May;37(3):171-181. doi: 10.1007/s40290-023-00470-2. Epub 
      2023 Apr 19.