Background
Seamless design concept originated from the idea of combining the dose ranging study and the confirmative study together. In oncology drug development, the seamless framework can be extended to a general multi-stage design that combines the exploratory stage and the confirmative stage. In addition, accelerated (conditional) approval pathway provides another opportunity for oncology agents based on early phase studies. Seamless development program may be an efficient approach to bring drugs to patients early. A large volume of statistical methodology articles appeared in this design framework in the past two decades, however it is still not commonly seen in real practice of oncology clinical trials.
Mission
- Understand the current practices, challenges, and gaps in implementing seamless development strategies in oncology drug development.
- Develop pragmatic statistical and operational solutions to the gaps and challenges that prevent the use of seamless designs in settings where they are efficient choices.
- Communicate and engage with statistical and non-statistical communities on the challenges and opportunities of oncology seamless development.
Members
| Name | Company |
|---|---|
| Philip He | Daiichi Sankyo |
| Yingwen Dong | Sanofi |
| Kristine Broglio | Astrazeneca |
| Mike (Guozhi) Gao | Eisai |
| Gautier Paux | Sanofi |
| Mike Xiao | Vanda |
| Freda Cooner | Arcutis |
| X.Q Xue | Syneos Health |
| Min Yi | Arrowhead Pharma |
| Michelle Fan-Port | Arsenalbio |
| Yi Xia | Alphamab |
| Zhao Yang | Amgen |
| Junhong Zhu | Replimune |
| Wei He | GSK |
| Chang Yu | New York University |
| Lei Gao | Moderna |
Projects
- Conduct a survey to understand the use of the seamless development program in oncology in biopharmaceutical industry and academic research institutions. Write a manuscript for the findings of the survey.
- Perform a meta-analysis to create a list of practical clinical studies that implemented the seamless development strategy. Prepare a manuscript for the findings.
- Promote oncology seamless development by organizing technical sessions in statistical conferences and communities.