| Scope |
|---|
The scope of this project is to evaluate and recommend approaches for SEND harmonization to better enable analysis of historical control data. SEND harmonization strategies include creation of new variables, controlled terminology, preferred terms, reference lists and/or analysis strategies (scripts) to enable cross study analysis. Developing a solution framework for variability that includes representation of stakeholders involved in the creation and use of SEND datasets will enable more efficient routine analysis of warehoused SEND data. |
Project Leads | |
|---|---|
Kevin Synder | kevin.snyder@fda.hhs.gov |
Mark Carfagna | carfagna_mark_a@lilly.com |
Key Milestones
| Objective | Timeline |
|---|---|
| Prioritised list of domains/variables required for harmonisation | Q3 2020 |
| Develop harmonisation recommendations for selected domains/variables and create white paper(s) for specific domains/variables as needed | Q2 2021 |
| Poster presentation and update of current working group progress at CSS | Q2 2021 |
| PHUSE Publication or white paper | Q2 2021 |
CURRENT STATUS
| Resources | |
|---|---|
| Vehicle Components Survey | Draft White Paper |
| SEND Package A | |
| SEND Package B | |
| SEND Package C | |
| SEND Package D |
Project Members | Organisation |
|---|---|
| Bill Houser | BMS |
Cheryl Sloan | BMS |
Deepa Smant | Comcast |
Erin Mulrooney | BioCelerate |
Gen Sato | Eisai |
Joseph Horvath | BMS |
Michele Dunleavy | Biocelerate |
Project Members | Organisation |
|---|---|
| Nicolas Philippe | PointCross |
Patricia Brundage | FDA |
Steve Polley | GSK |
Sue Dehaven | Sanofi |
Todd Page | Eli Lilly |
Wang Wenxian | Xybion |
Volunteer Today
Our project always welcomes new members to collaborate in an open, transparent and non-competitive project. If you are interested in joining please contact workinggroups@phuse.eu.