FDA Fellowship: Evaluation of Novel Endpoints and Innovative Statistical Methodology in Oncology Clinical Trials

Organization

U.S. Food and Drug Administration (FDA)

FDA-CDER-

10/23/2026 3:00:00 PM Eastern Time Zone

• Applications will be reviewed on a rolling-basis.

A research opportunity is available immediately with the Food and Drug Administration (FDA), Center for Drug Evaluation and Research (CDER), located in Silver Spring, Maryland.

The Center for Drug Evaluation and Research (CDER) performs an essential public health task by making sure that safe and effective drugs are available to improve the health of people in the United States. As part of the U.S. Food and Drug Administration (FDA), CDER regulates over‑the‑counter and prescription drugs, including biological therapeutics and generic drugs. These efforts cover more than just medicines.

This research project aims to develop and evaluate innovative statistical methods and novel clinical trial endpoints in oncology, addressing key methodological gaps that have emerged as cancer therapies grow more complex and patient‑centered outcomes become increasingly central to regulatory decision‑making. Some topics for research as a part of this program could include:

Novel Endpoints Involving Repeated Measurements Over Time:
Traditional time‑to‑event endpoints may not fully capture the longitudinal burden of disease or the dynamic trajectory of treatment benefit in oncology. This project will investigate endpoints that incorporate repeated measurements over time — such as tumor burden trajectories, patient‑reported tolerability endpoints, or other endpoints of interest. Statistical approaches under evaluation could include joint models for longitudinal and time‑to‑event data, mixed‑effects models for repeated measures (MMRM), non‑parametric methods, and multistate models that characterize transitions across clinically relevant health states throughout the disease course.

Intercurrent Events with Differential Prognostic Impact:
Standard approaches to handling intercurrent events — such as avoidance of surgery in the perioperative treatment setting, transplant, treatment switching or use of subsequent therapies, or dose modifications — often fail to account for their heterogeneous prognostic implications. This project will evaluate principled estimand frameworks, consistent with ICH E9(R1), for defining and estimating treatment effects in the presence of intercurrent events whose occurrence may itself carry prognostic information.

Methods of interest could include survivor average causal effect (SACE) estimators and principal stratification approaches that explicitly condition on patient subpopulations defined by intercurrent event status, with the goal of producing clinically interpretable estimates that reflect meaningful treatment contrasts.

Evaluation of Novel Endpoints in Rare Disease Settings:
Many rare oncology disease settings have clinical trial design challenges due to a lack of available endpoints beyond overall survival. Other clinically relevant end points may exist, but without data from randomized clinical trials that capture both the novel endpoint of interest and overall survival, these endpoints cannot be formally validated. Innovative methods for evaluation of these endpoints could be explored to investigate the utility of their use in clinical trials for patients with rare tumors.

Collectively, these research areas address important methodological needs at the intersection of regulatory science, clinical trial design, and patient‑centered outcomes in oncology.

• Gain comprehensive education in oncology clinical trials through structured learning opportunities, available regulatory guidance, and fellowship‑program resources.
• De…