Project 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 (FDA) | |
Mark Carfagna (Eli Lilly, BioCelerate Consortium) | |
| Katie Warren (PHUSE Project Assistant) |
| Objectives & Deliverables | Timelines |
|---|---|
| Prioritised list of domains/variables required for harmonisation | Q32020 |
| Develop harmonisation recommendations for selected domains/variables and create white paper(s) for specific domains/variables as needed | Q22021 |
| Poster presentation and update of current Working Group progress at CSS | Q32021 |
| PHUSE Publication of White Paper | Q22022 |
CURRENT STATUS Q12022 |
|---|
Recommendations for Consistent Representation of Test Facilities, Test Sites, and Subject Metadata Using SEND Controlled Terminology White Paper sent out for public review |
Project Members | Organisation |
|---|---|
| Annika Kreuchwig | Bayer |
| Bill Houser | Bristol Myers Squibb, BioCelerate Consortium |
| Cara Rinaldi | BioCelerate |
Cheryl Sloan | Bristol Myers Squibb, BioCelerate Consortium |
Deepa Smant | Comcast |
| Frank Bringezu | Merck |
Gen Sato | Eisai |
| Joseph Horvath | Bristol Myers Squibb |
| Laura Kaufman | Pointcross |
| Lokesh Babu | Pointcross |
| Matthew Crawley | Biocelerate |
| Michael DeNieu | Labcorp |
| Michael Wasko | PDS Life Sciences |
Michele Dunleavy | Biocelerate |
| Nicolas Philippe | PointCross Life Sciences |
| Patricia Brundage | FDA |
| Rick Thompson | Janssen Research & Development, BioCelerate Consortium |
| SivaRamaKrishna VemiReddy | Pointcross |
| Steve Polley | GSK |
| Sue Dehaven | Sanofi |
| Todd Page | Eli Lilly |
| Vidhuna Sadanandan | Labcorp |
| Wang Wenxian | Bristol Myers Squibb, BioCelerate Consortium |
| William Houser | Bristol Myers Squibb |