Combination therapy/ Dose-Optimization WS:
Master Protocols/ Tumor Agnostic Approvals WS:
o Preparing a book “Master Protocol Clinical Trials for Efficient Evidence Generation: Development Strategies, Study Designs, Operational Engagement, and Case Studies” (joint efforts with DahShu IDSWG)
o Working on a review paper on CoC
Enrichment Designs / RWE in Oncology Development/ Interim Evaluation of OS WS:
- Working on a manuscript on OS interim evaluation in PFS trials.
Pediatric Trial designs WS:
- Working on a manuscript on pediatric oncology registries.
Joint Modeling WS:
- Working on a manuscript focusing on the Bayesian joint modeling of longitudinal biomarkers and survival outcomes.
Treatment Switch WS:
- Working on a tutorial paper on treatment switching
- Working on implementation and code standardization
- Will work on research topics on treatment switching
Statistical Methods in Oncology Scientific Working Group initiated virtual Open Forums in collaboration with LUNGevity Foundation and in coordination with the US FDA Oncology Center of Excellence under Project SignifiCanT (https://www.fda.gov/about-fda/oncology-center-excellence/project-significant-statistics-cancer-trials):
2024
- Interpretation of Results from Hierarchical Testing of Multiple Endpoints, Subgroups, Analyses Across Disease Settings in Cancer Clinical Trials
2023
- Non-inferiority Cancer Clinical Trial Design Considerations when Data from a Single Foreign Country is Available – Part 2
- Statistical Considerations in the Early Interim Overall Survival Analysis in Indolent Cancers for Evaluation of Risk – Part 2
- Consideration of Criteria for Evaluation of Surrogate Endpoint
- Cancer Clinical Trial Design and Analysis Considerations in Evaluating Treatment Effect in Marker Negative Population – Part 2
- Design Considerations in the Evaluation of Contribution of Effect of Combination of Two New Investigational Drugs in Randomized Cancer Clinical Trials
- Impact of Cross-over in the Evaluation of Overall Survival in Randomized Cancer Clinical Trials
- Considerations in requiring blinded independent central review of radiological scans in randomized cancer clinical trials when progression-free survival is the primary endpoint
2022
- Statistical Considerations in Pediatric Cancer Trials – Part 2
- Summarizing Treatment Effect for Time-to-event Endpoints in Cancer Clinical Trials in the Presence of Non-proportional Hazards – Part 2
- Impact on Type I error with Unplanned Analyses in Cancer Clinical Trials
- Statistical Considerations in the Evaluation and Interpretation of Interim Overall Survival Results in Patients with Chronic Diseases from Randomized Cancer Clinical Trials
- Considerations for Data Monitoring Committee and Regulator Direct Interactions in Ongoing Randomized Cancer Clinical Trials
- Considerations in the Evaluation of Progression Free Survival with Informative Censoring in Cancer Clinical Trials
- Assessing Bias in Cancer Studies with Real World Data Elements
- Considerations of innovative cancer clinical trial designs for post-market dose-optimization studies
2021
- Statistical Considerations in Oncology Clinical Trials in the COVID-19 Era – Part 1 and Part 2
- Designing Dose-optimization Studies in Cancer Drug Development – Part 1, Part 2 and Part 3
- Evaluation of Treatment Effect in Underrepresented Population in Oncology Clinical Trials – Part 1 and Part 2
- Statistical Considerations in Pediatric Cancer Trials – Part 1
- Summarizing Treatment Effect for Time-to-event Endpoints in Cancer Clinical Trials in the Presence of Non-proportional Hazards – Part 1
- Cancer Clinical Trial Design Considerations when Accepting Foreign Data from a Single Country
- Cancer Clinical Trial Design Considerations in Evaluating Treatment Effect in Marker Negative Population
2020
- Type I error Considerations in Master Protocols with Common Control in Oncology Clinical Trials
- Use of Non-concurrent Common Control for Treatment Comparisons in Master Protocols