448 results on '"Kluetz, Paul G."'
Search Results
2. False-Positive Circulating Tumor DNA Results Do Not Explain Lack of Efficacy for PARP Inhibitors in Patients With Castration-Resistant Prostate Cancer Harboring ATM and CHEK2 Mutations
3. Correlations of response rate and progression-free survival with overall survival in immunotherapy trials for metastatic non-small-cell lung cancer: an FDA pooled analysis
4. Patient-reported frailty phenotype (PRFP) vs. International Myeloma Working Group frailty index (IMWG FI) proxy: A comparison between two approaches to measuring frailty
5. Rethinking Cancer Clinical Trial Conduct Induced by COVID-19: An Academic Center, Industry, Government, and Regulatory Agency Perspective
6. Measuring Frailty Using Patient-Reported Outcomes (PRO) Data: A Feasibility Study in Patients with Multiple Myeloma
7. Proceedings of the Comprehensive Oncology Network Evaluating Rare CNS Tumors (NCI-CONNECT) Oligodendroglioma Workshop.
8. Feasibility of structuring electronic health record data to facilitate real‐world data research: ICAREdata methods applied to multicenter cancer clinical trials.
9. Reaching beyond maximum grade: progress and future directions for modernising the assessment and reporting of adverse events in haematological malignancies
10. Time to deterioration of symptoms or function using patient-reported outcomes in cancer trials
11. FDA Approval Summary: Durvalumab and Pembrolizumab, Immune Checkpoint inhibitors for the Treatment of Biliary Tract Cancer
12. Refining neoadjuvant therapy clinical trial design for muscle-invasive bladder cancer before cystectomy: a joint US Food and Drug Administration and Bladder Cancer Advocacy Network workshop
13. FDA review summary of patient-reported outcome results for ibrutinib in the treatment of chronic graft versus host disease
14. Survival outcomes in older men with non-metastatic castration-resistant prostate cancer treated with androgen receptor inhibitors: a US Food and Drug Administration pooled analysis of patient-level data from three randomised trials
15. Patient-Reported Outcomes After Treatment Discontinuation: Commercial Clinical Trial Data From Four Cancer Types
16. Does Knowledge of Treatment Assignment Affect Patient Report of Symptoms, Function, and Health Status? An Evaluation Using Multiple Myeloma Trials
17. The Oncology QCARD Initiative: Fostering efficient evaluation of initial real‐world data proposals.
18. US Food and Drug Administration Approval Summary: Eflornithine for High-Risk Neuroblastoma After Prior Multiagent, Multimodality Therapy.
19. Demystifying the estimand framework: a case study using patient-reported outcomes in oncology
20. FDA Approval Summary: Fruquintinib for the Treatment of Refractory Metastatic Colorectal Cancer
21. Supplementary Table S2 from FDA Approval Summary: Enfortumab Vedotin plus Pembrolizumab for Cisplatin-Ineligible Locally Advanced or Metastatic Urothelial Carcinoma
22. Supplementary Figure S1 from FDA Approval Summary: Enfortumab Vedotin plus Pembrolizumab for Cisplatin-Ineligible Locally Advanced or Metastatic Urothelial Carcinoma
23. Data from FDA Approval Summary: Enfortumab Vedotin plus Pembrolizumab for Cisplatin-Ineligible Locally Advanced or Metastatic Urothelial Carcinoma
24. FDA Approval Summary: Enfortumab Vedotin plus Pembrolizumab for Cisplatin-Ineligible Locally Advanced or Metastatic Urothelial Carcinoma
25. Cytoreductive nephrectomy in the era of immune checkpoint inhibitors: a US Food and Drug Administration pooled analysis
26. Exploring racial disparities in treatment patterns and outcomes for patients with multiple myeloma using real world data
27. Public-private partnerships in transplant drug development
28. CDK4/6 inhibitor treatment for patients with hormone receptor-positive, HER2-negative, advanced or metastatic breast cancer: a US Food and Drug Administration pooled analysis
29. International standards for the analysis of quality-of-life and patient-reported outcome endpoints in cancer randomised controlled trials: recommendations of the SISAQOL Consortium
30. Current state of quality of life and patient-reported outcomes research
31. US Food and Drug Administration review of statistical analysis of patient-reported outcomes in lung cancer clinical trials approved between January, 2008, and December, 2017
32. Clinical Evidence Generation During a Pandemic: Lessons Learned for Sustaining Progress
33. A Pooled Analysis of Treatment-Free Survival in Advanced Renal Cell Carcinoma
34. Considering Functional Outcomes as Efficacy Endpoints in Pediatric Low-Grade Glioma Clinical Trials: An FDA Educational Symposium
35. Supplementary Table S1 from FDA Approval Summary: Alpelisib for PIK3CA-Related Overgrowth Spectrum
36. Data from FDA Approval Summary: Alpelisib for PIK3CA-Related Overgrowth Spectrum
37. When less is more—reducing complexity in cancer trials
38. FDA Approval Summary: Olaparib in Combination With Abiraterone for Treatment of Patients With BRCA-Mutated Metastatic Castration-Resistant Prostate Cancer
39. Beyond maximum grade: modernising the assessment and reporting of adverse events in haematological malignancies
40. Review of patient-reported outcomes in multiple myeloma registrational trials: highlighting areas for improvement
41. Informing the Tolerability of Cancer Treatments Using Patient-Reported Outcome Measures: Summary of an FDA and Critical Path Institute Workshop
42. Incorporating the patient experience into regulatory decision making in the USA, Europe, and Canada
43. FDA Approval Summary: Tremelimumab in Combination with Durvalumab for the Treatment of Patients with Unresectable Hepatocellular Carcinoma
44. Advancing Clinical Trial Design for Non-Muscle Invasive Bladder Cancer
45. Immune Response Evaluation and Treatment with Immune Checkpoint Inhibitors Beyond Clinical Progression: Response Assessments for Cancer Immunotherapy
46. Efficacy of Poly(ADP-ribose) Polymerase Inhibitors by Individual Genes in Homologous Recombination Repair Gene-Mutated Metastatic Castration-Resistant Prostate Cancer: A US Food and Drug Administration Pooled Analysis.
47. FDA Approval Summary: Alpelisib for PIK3CA-Related Overgrowth Spectrum
48. FDA Approval Summary: Dabrafenib in combination with trametinib for BRAF V600E mutation-positive low-grade glioma
49. FDA Approval Summary: Ribociclib Indicated for Male Patients with Hormone Receptor-Positive, HER2-Negative Advanced or Metastatic Breast Cancer
50. FDA Approval Summary: Futibatinib for Unresectable Advanced or Metastatic, Chemotherapy Refractory Intrahepatic Cholangiocarcinoma with FGFR2 Fusions or Other Rearrangements
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