FDA Fellowship - Statistical Considerations in the Design and Analysis of Oncology Clinical Trials
Oak Ridge Institute for Science and Education · White Oak, MD · 2 mo ago
HealthcareFull-time
Research Project
A number of different design and analysis strategies have been proposed to address contribution of phase of therapy. The goal of this project is to investigate the impact of some of these options and to determine their impact on the drug approval process. Such design and analysis features include but are not limited to:
- Re-randomization
- 2:2:1 or 2:1:2 randomization to the multiple phase, single-phase, and control arms
- Estimation of impact of later phase via propensity score methods
- Use of a less stringent criterion to claim the additional phase is necessary (e.g., superiority vs single-phase therapy at a one-sided Type I error of 0.10)
- This project includes simulation of survival data in multiple phases (e.g., piecewise modeling).
- Evaluation of potential design features using clinical trial data to guide designs of similar future trials.
Learning Objectives
- Under the guidance of a mentor, you will learn, among other ideas:
- Research methods in this space by reviewing the scientific literature
- How to determine which design features are most efficient in determining contribution of phase
- Additional programming and modeling skills through generating simulations for the proposed designs
- How to communicate with statistical and clinical experts in oncology to understand the unique challenges in this space
Mentor
The mentor for this opportunity is Xin Wang (Xin.Wang@fda.hhs.gov). If you have questions about the nature of the research, please contact the mentor.
Evaluation of Clinical Trial Data
The evaluation of clinical trial data is an important aspect of this research project.
Qualification Requirements
- I am a U.S. citizen, or I have lived in the United States for at least 36 out of the past 60 months.
- I have read the FDA Ethics Requirements.
Contact Information
If you have questions, send an email to ORISE.FDA.CDER@orau.org. Please include the reference code for this opportunity in your email.