Statistical Methods in Clinical Trials and Drug Development

Displaying 1 - 12 of 12CSV
Goldberg, T. E., Lee, S., Devanand, D., & Schneider, L. S. S. (2024). Comparison of Relative Change with Effect Size Metrics in Alzheimer’s Disease Anti‐amyloid Clinical Trials. Alzheimer’s & Dementia, 20(S8). Portico. https://doi.org/10.1002/alz.094862
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Leuva, H., Zhou, M., Jamaleddine, N., Meseha, M., Faiena, I., Anna Park, Y.-H., McWilliams, G., Luhrs, C., Maxwell, K. N., Von Hoff, D., Bates, S. E., & Fojo, T. (2024). Assessing olaparib efficacy in U.S. Veterans with metastatic prostate cancer utilizing a time-indifferent -rate method ideal for real-world analyses. EBioMedicine, 107, 105288. https://doi.org/10.1016/j.ebiom.2024.105288
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Zhang, L., Richter, L. R., Wang, Y., Ostropolets, A., Elhadad, N., Blei, D. M., & Hripcsak, G. (2024). Causal fairness assessment of treatment allocation with electronic health records. Journal of Biomedical Informatics, 155, 104656. https://doi.org/10.1016/j.jbi.2024.104656
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Fojo, T., LaRose, M., & Bates, S. E. (2024). The Impact of Exuberance on Equipoise in Oncology Clinical Trials: Sotorasib as Archetype. The Oncologist, 29(4), 275–277. https://doi.org/10.1093/oncolo/oyae042
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He, P., Gambhire, D., Zhou, H., Ma, X., Emura, Y., Laadem, A., Leung, D., Bates, S. E., Fojo, A. T., & Rixe, O. (2024). 76P Utilization of g score in early oncology drug development: Impact on study design and early go/no-go decision. ESMO Open, 9, 102304. https://doi.org/10.1016/j.esmoop.2024.102304
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Goldberg, T. E., Lee, S., Devanand, D. P., & Schneider, L. S. (2023). Comparison of relative change with effect size metrics in Alzheimer’s disease clinical trials. Journal of Neurology, Neurosurgery & Psychiatry, 95(1), 2–7. https://doi.org/10.1136/jnnp-2023-331941
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Najjar, M., McCarron, J., Cliff, E. R. S., Berger, K., Steensma, D. P., Al Hadidi, S., Chakraborty, R., Goodman, A., Anto, E., Greene, T., Sborov, D., & Mohyuddin, G. R. (2023). Adverse Event Reporting in Randomized Clinical Trials for Multiple Myeloma. JAMA Network Open, 6(11), e2342195. https://doi.org/10.1001/jamanetworkopen.2023.42195
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Wu, Q., Schuemie, M. J., Suchard, M. A., Ryan, P., Hripcsak, G. M., Rohde, C. A., & Chen, Y. (2023). Padé approximant meets federated learning: A nearly lossless, one-shot algorithm for evidence synthesis in distributed research networks with rare outcomes. Journal of Biomedical Informatics, 145, 104476. https://doi.org/10.1016/j.jbi.2023.104476
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Buxton, M., Alexander, B., Berry, D., Cavenee, W., Colman, H., de Groot, J., Ellingson, B., Gordon, G., Khasraw, M., Lassman, A., Lee, E., Li, W., Lim, M., Mellinghoff, I., Mikkelsen, T., Nelli, A., Perry, J., Sulman, E., Tanner, K., … Cloughesy, T. (2022). CTNI-38. UPDATE ON GBM AGILE: A GLOBAL, PHASE 2/3 ADAPTIVE PLATFORM TRIAL TO EVALUATE MULTIPLE REGIMENS IN NEWLY DIAGNOSED AND RECURRENT GLIOBLASTOMA. Neuro-Oncology, 24(Supplement_7), vii80–vii80. https://doi.org/10.1093/neuonc/noac209.303
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Mazza, G. L., Petersen, M. M., Ginos, B., Langlais, B. T., Heon, N., Gounder, M. M., Mahoney, M. R., Zoroufy, A. J., Schwartz, G. K., Rogak, L. J., Thanarajasingam, G., Basch, E., & Dueck, A. C. (2021). Missing data strategies for the Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) in Alliance A091105 and COMET-2. Quality of Life Research, 31(4), 1069–1080. https://doi.org/10.1007/s11136-021-02968-1
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Parisien, R. L., Trofa, D. P., Cronin, P. K., Dashe, J., Curry, E. J., Eichinger, J. K., Levine, W. N., Tornetta, P., & Li, X. (2021). Comparative Studies in the Shoulder Literature Lack Statistical Robustness: A Fragility Analysis. Arthroscopy, Sports Medicine, and Rehabilitation, 3(6), e1899–e1904. https://doi.org/10.1016/j.asmr.2021.08.017
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