Synergy in Action

Analysis of SIB Data Subgroup

Analysis of SIB Data Bibliography

Working Group Goal:
Review current status  and develop consensus regarding guiding principles and considerations when analyzing existing SIB data at the study, program and meta-analytic level and identification of gaps in current analytic approaches

Possible Activities:

–Review approaches for summarizing and analyzing clinical trial and project level data

  • Summarization of SIB data without respect to treatment
  • Analysis of SIB data in association with treatment
  • Aggregation of SIB data with other study endpoints (eg, MADRS)
  • Use of common data elements
  • Relationship between SIB assessments and AE reporting
  • Meta-analysis/network analysis of existing large datasets

–Review approaches for leveraging big data for SIB datasets and identifying emerging opportunities

–Identify challenges in assembling and analyzing large SIB datasets

Sub-group Members:

Munaf Ali, Munaf Ali Consultancy
John Davies, GSK
Bryan Dirks, Shire
Sarah DuBrava, Pfizer
Rebecca Evans, Parexel
Michael Federico, ERT
Andrew Freeman, Univ of Nevada, Las Vegas
Mark Gordon, Boehringer-Ingelheim
Pilar Lim, Janssen
Cristiana Mayer, Janssen
Mary Nilsson, Lilly
Jill Rasmussen, psi-napse
Madhukar Trivedi, Univ of Texas SWMC
Christine Ulbricht, UMass Medical School
Robieson Weining, AbbVie
Anna van Meter, Einstein College of Medicine
Benedetto Vitiello, NIMH
Jun Zhao, AbbVie

Analysis of SIB Data Working Group Internal Documents