Project Scope Impact assessment of the estimands framework and recommendations/best practices (where applicable) for implementing the framework in the following areas:
Development of new standards is not in scope, and any impact findings that may necessitate new standard development will be shared with CDISC for their consideration. Examples may be created on how to implement the framework by using permitted extensions to the existing data standards. |
| Project Leads | |
| Chris Price | |
| Lori VanMeter | lvanmet@ITS.JNJ.com |
| Katie Warren (PHUSE Project Assistant) |
| Objectives & Deliverables | Timelines |
Kick off | Q1 2022 |
Review current company practices | Q1 2022 |
Develop conference abstract | Q2 2022 |
Draft paper | Q3 2022 |
Conference slides | Q4 2022 |
Final paper for public review | Q4 2022 |
Final paper published | Q1 2023 |
CURRENT STATUS | |
| Project approved Q1 2022 |
| Project Members | Organisation |
|---|---|
| Arman Sabbaghi | Purdue University |
| Armin Schueler | Merckgroup |
| Bess Leroy | CDISC |
| Cedric Davister | Merck |
| Elena Polverejan | Janssen Research & Development |
| John Scott | FDA |
| Junxiang Luo | Moderna |
| Kim Musgrave | Amgen |
| Liping Sun | FDA |
| Lisa Lin | FDA |
| Marc Walton | Janssen Research & Development |
| Rama Empati | AstraZeneca |
| Robin White | Eli Lilly and Company |
| Rosanne Lane | Janssen Research & Development |
| Santosh K Lingala | Gilead |
| Shahida Tamboli | Labcorp |
| Stephen Ruberg | Analytix Thinking |
| Steve Gilbert | Pfizer |
| Steve Wilson | FDA |
| Yongming Qu | Eli Lilly and Company |