P. Mishra-Kalyani

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Propensity Process: a Balancing Functional

Brent A. Johnson, Q. Long, P. Mishra-Kalyani, 2019, 1905.02065.

FDA Approval Summary: Pralsetinib for the Treatment of Lung and Thyroid Cancers With RET Gene Mutations or Fusions

Jiang Liu, Jielin Sun, Reena Philip, 2021, Clinical Cancer Research.

The FDA Oncology Center of Excellence Scientific Collaborative: Charting a Course for Applied Regulatory Science Research in Oncology

W. Rubinstein, L. Fashoyin-Aje, K. Goldberg, 2021, Clinical Cancer Research.

Time to treatment discontinuation (TTD) as a pragmatic endpoint in metastatic non-small cell lung cancer (mNSCLC): A pooled analysis of 8 trials.

S. Khozin, K. Kehl, G. Blumenthal, 2018 .

FDA Approval Summary: Nivolumab in Combination with Ipilimumab for the Treatment of Unresectable Malignant Pleural Mesothelioma

Jiang Liu, Martha Donoghue, R. Pazdur, 2021, Clinical Cancer Research.

FDA Approval Summary: Osimertinib for Adjuvant Treatment of Surgically Resected Non–Small Cell Lung Cancer, a Collaborative Project Orbis Review

Jiang Liu, R. Pazdur, U. Rohr, 2021, Clinical Cancer Research.

Global Variation in Opioid Use in Prostate Cancer Trials.

R. Pazdur, J. Roydhouse, G. Blumenthal, 2019, JAMA oncology.

FDA Approval Summary: Selumetinib for Plexiform Neurofibroma

Jiang Liu, K. Goldberg, R. Pazdur, 2021, Clinical Cancer Research.

FDA Approval Summary: Pembrolizumab for the Treatment of Patients with Unresectable or Metastatic Melanoma

Huanyu Chen, P. Keegan, R. Pazdur, 2017, Clinical Cancer Research.

Outcomes of anti-PD-(L1) therapy in combination with chemotherapy versus immunotherapy (IO) alone for first-line (1L) treatment of advanced non-small cell lung cancer (NSCLC) with PD-L1 score 1-49%: FDA pooled analysis.

R. Pazdur, Shenghui Tang, J. Beaver, 2021 .

FDA analyses of survival in older adults with metastatic non-small cell lung cancer in controlled trials of PD-1/PD-L1 blocking antibodies.

P. Keegan, R. Pazdur, G. Blumenthal, 2018, Seminars in oncology.

FDA Approval Summary: Atezolizumab and Durvalumab in Combination with Platinum-Based Chemotherapy in Extensive Stage Small Cell Lung Cancer.

K. Goldberg, R. Pazdur, M. Theoret, 2021, The oncologist.

The Current Landscape in Biostatistics of Real-World Data and Evidence: Clinical Study Design and Analysis

M. J. van der Laan, Xiwu Lin, Z. Meng, 2021, Statistics in Biopharmaceutical Research.

FDA Approval Summary: Cabozantinib for Differentiated Thyroid Cancer.

Jiang Liu, R. Pazdur, Hong Zhao, 2022, Clinical cancer research : an official journal of the American Association for Cancer Research.

Unresectable and Metastatic Melanoma of the Skin: Literature Review of Clinical Trials and Efficacy Endpoints Since 2000

R. Sridhara, P. Mishra-Kalyani, Susan Jin, 2019, Therapeutic innovation & regulatory science.

FDA Approval Summary: Pembrolizumab for Treatment of Metastatic Non‐Small Cell Lung Cancer: First‐Line Therapy and Beyond

K. Goldberg, P. Keegan, Amy McKee, 2017, The oncologist.

External Control Arms in Oncology: Current Use and Future Directions.

J. Concato, R. Pazdur, R. Sridhara, 2022, Annals of oncology : official journal of the European Society for Medical Oncology.

Arm Pain in Youth Baseball Players

E. Makhni, C. Ahmad, P. Mishra-Kalyani, 2015, The American journal of sports medicine.

K. Goldberg, R. Pazdur, L. Rimassa, 2021, European journal of cancer.

Analysis of time-to-treatment discontinuation of targeted therapy, immunotherapy, and chemotherapy in clinical trials of patients with non-small-cell lung cancer.

S. Khozin, K. Goldberg, R. Pazdur, 2019, Annals of oncology : official journal of the European Society for Medical Oncology.

FDA Approval Summary: Pembrolizumab, Atezolizumab, and Cemiplimab-rwlc as single agents for first-line treatment of advanced/metastatic PD-L1 high NSCLC.

Jiang Liu, Martha Donoghue, R. Pazdur, 2022, Clinical cancer research : an official journal of the American Association for Cancer Research.

FDA analysis of depth of response (DpR) and survival across 10 randomized controlled trials in patients with previously untreated unresectable or metastatic melanoma (UMM) by therapy type.

P. Keegan, R. Pazdur, R. Sridhara, 2019, Journal of Clinical Oncology.

Biostatistical Considerations When Using RWD and RWE in Clinical Studies for Regulatory Purposes: A Landscape Assessment

Yixin Fang, Richard C. Zink, Benjamin A. Goldstein, 2021, Statistics in Biopharmaceutical Research.

Does Knowledge of Treatment Assignment Affect Patient Report of Symptoms, Function, and Health Status? An Evaluation Using Multiple Myeloma Trials.

R. Gutman, B. King-Kallimanis, J. Roydhouse, 2021, Value in health : the journal of the International Society for Pharmacoeconomics and Outcomes Research.

The Current Landscape in Biostatistics of Real-World Data and Evidence: Causal Inference Frameworks for Study Design and Analysis

Qi Jiang, Yixin Fang, Xiwu Lin, 2021, Statistics in Biopharmaceutical Research.

FDA Approval Summary: Sotorasib for KRAS G12C Mutated Metastatic NSCLC.

Jiang Liu, R. Pazdur, Hong Zhao, 2021, Clinical cancer research : an official journal of the American Association for Cancer Research.

Analysis of time-to-treatment discontinuation of targeted therapy, immunotherapy, and chemotherapy in clinical trials of patients with non-small-cell lung cancer.

S. Khozin, K. Goldberg, R. Pazdur, 2019, Annals of oncology : official journal of the European Society for Medical Oncology.

FDA Approval Summary: Capmatinib and Tepotinib for the Treatment of Metastatic NSCLC Harboring MET Exon 14 Skipping Mutations or Alterations

Jiang Liu, Reena Philip, K. Goldberg, 2021, Clinical Cancer Research.

Outcomes of anti–PD-(L)1 therapy with or without chemotherapy (chemo) for first-line (1L) treatment of advanced non–small cell lung cancer (NSCLC) with PD-L1 score ≥ 50%: FDA pooled analysis.

Martha Donoghue, R. Pazdur, Shenghui Tang, 2022, Journal of Clinical Oncology.

FDA Approval Summary: Mobocertinib for Metastatic Non-Small Cell Lung Cancer with EGFR Exon 20 Insertion Mutations.

Jiang Liu, Reena Philip, Martha Donoghue, 2022, Clinical cancer research : an official journal of the American Association for Cancer Research.

Outcomes of first-line immune checkpoint inhibitors with or without chemotherapy according to KRAS mutational status and PD-L1 expression in patients with advanced NSCLC: FDA pooled analysis.

R. Pazdur, Shenghui Tang, J. Beaver, 2022, Journal of Clinical Oncology.

Examples of Applying RWE Causal-Inference Roadmap to Clinical Studies

M. J. van der Laan, Susan Gruber, D. Benkeser, 2023, Statistics in Biopharmaceutical Research.

FDA Approval Summary: Pemigatinib for Previously Treated, Unresectable Locally Advanced or Metastatic Cholangiocarcinoma with FGFR2 fusion or other rearrangement.

Jiang Liu, L. Fashoyin-Aje, Martha Donoghue, 2022, Clinical cancer research : an official journal of the American Association for Cancer Research.

Analyzing patient‐reported outcome data when completion differs between arms in open‐label trials: an application of principal stratification

R. Gutman, J. Roydhouse, R. Sridhara, 2019, Pharmacoepidemiology and drug safety.

Association between antibiotics and adverse oncological outcomes in patients receiving targeted or immune-based therapy for hepatocellular carcinoma

L. Fashoyin-Aje, R. Pazdur, A. Cortellini, 2023, JHEP reports : innovation in hepatology.

Estimating the effect of PEG in ALS patients using observational data subject to censoring by death and missing outcomes

Brent A. Johnson, J. Glass, Q. Long, 2019, 1905.02062.

FDA Approval Summary: Amivantamab for the Treatment of patients with non-small cell lung cancer with EGFR exon 20 insertion mutations.

Jiang Liu, Jielin Sun, Reena Philip, 2023, Clinical cancer research : an official journal of the American Association for Cancer Research.

FDA Accelerated Approval of Pembrolizumab for Recurrent Locally Advanced or Metastatic Merkel Cell Carcinoma.

P. Keegan, R. Pazdur, S. Lemery, 2020, The oncologist.

Time to treatment failure (TTF) as a potential clinical endpoint in real-world evidence (RWE) studies of melanoma.

R. Sridhara, M. Theoret, P. Mishra-Kalyani, 2018 .

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.

R. Pazdur, P. Kluetz, P. Mishra-Kalyani, 2024, The Lancet. Oncology.