Search Results - "Cooner, Freda"

Advancing innovative clinical trials to efficiently deliver medicines to patients by Beckman, Robert A., Natanegara, Fanni, Singh, Pritibha, Cooner, Freda, Antonijevic, Zoran, Liu, Yi, Mayer, Cristiana, Price, Karen, Tang, Rui, Xia, Amy, Apostolaros, Maria, Granville, Courtney, Michaels, Debra

“…Complex innovative designs in clinical trials have the potential to increase efficiency and lower the cost of drug development, improving patient access to…”
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A Systematic Review of Adaptive Seamless Clinical Trials for Late-Phase Oncology Development by Broglio, Kristine, Cooner, Freda, Wu, Yujun, Xiao, Mike, Xue, X Q, Lowen, Marina, Ikhapoh, Izuagie, He, Philip

“…Although oncology has seen large scientific and clinical advances over the last decade, it also has one of the lowest success rates for novel agents across…”
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Use of Seamless Study Designs in Oncology Clinical Development- A Survey Conducted by IDSWG Oncology Sub-team by Dong, Yingwen, Paux, Gautier, Broglio, Kristine, Cooner, Freda, Gao, Guozhi, He, Wei, Gao, Lei, Xue, Xiaoqiang, He, Philip

“…Seamless study designs have the potential to accelerate clinical development. The use of innovative seamless designs has been increasing in the oncology area;…”
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Clinical trial considerations for pediatric cancer drug development by Cooner, Freda, Ye, Jingjing, Reaman, Gregory

“…Oncology has been one of the most active therapeutic areas in medicinal products development. Despite this fact, few drugs have been approved for use in…”
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RESTART trial design: two-stage seamless transition design with operational considerations by Yi, Min, Zhuo, Bin, Cooner, Freda

“…Oncology/hematology is a competitive therapeutic area where the landscape is constantly evolving. With regulatory support, many drug developers have spent a…”
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Hierarchical dynamic time-to-event models for post-treatment preventive care data on breast cancer survivors by Cooner, Freda W, Yu, Xinhua, Banerjee, Sudipto, Grambsch, Patricia L, McBean, A Marshall

“…This paper considers modelling data arising in post-treatment preventive care settings, where cancer patients who have undergone disease-directed treatment…”
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A phase 1 study of AMG 509 in patients (pts) with metastatic castration-resistant prostate cancer (mCRPC) by Danila, Daniel Costin, Waterhouse, David Michael, Appleman, Leonard Joseph, Pook, David William, Matsubara, Nobuaki, Dorff, Tanya B., Lee, Jae-Lyun, Armstrong, Andrew J., Kim, Miso, Horvath, Lisa, Sumey, Christopher Joseph, Cooner, Freda, Salvati, Mark, Stieglmaier, Julia, Kelly, William Kevin

“…TPS5101 Background: Six-transmembrane epithelial antigen of prostate 1 (STEAP1) is overexpressed on the surface of prostate cancer cells with low or no…”
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Flexible Cure Rate Modeling Under Latent Activation Schemes by Cooner, Freda, Banerjee, Sudipto, Carlin, Bradley P, Sinha, Debajyoti

“…With rapid improvements in medical treatment and health care, many datasets dealing with time to relapse or death now reveal a substantial portion of patients…”
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The win odds: statistical inference and regression by Song, James, Verbeeck, Johan, Huang, Bo, Hoaglin, David C., Gamalo-Siebers, Margaret, Seifu, Yodit, Wang, Duolao, Cooner, Freda, Dong, Gaohong

“…Generalized pairwise comparisons and win statistics (i.e., win ratio, win odds and net benefit) are advantageous in analyzing and interpreting a composite of…”
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Platform trials to evaluate the benefit-risk of COVID-19 therapeutics: Successes, learnings, and recommendations for future pandemics by Buenconsejo, Joan, Liao, Ran, Lin, Junjing, Singh, Pritibha, Cooner, Freda, Ghosh, Samiran, Gamalo, Margaret, Russek-Cohen, Estelle, Zariffa, Névine

“…In response to the COVID-19 global pandemic, multiple platform trials were initiated to accelerate evidence generation of potential therapeutic interventions…”
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Safety and efficacy of AMG 160, a half-life extended BiTE immune therapy targeting prostate-specific membrane antigen (PSMA), and other therapies for metastatic castration-resistant prostate cancer (mCRPC) by Subudhi, Sumit Kumar, Siddiqui, Bilal A., Maly, Joseph J., Nandagopal, Lakshminarayanan, Lam, Elaine Tat, Whang, Young E., Minocha, Mukul, Gupta, Vinita, Penny, Xianne, Cooner, Freda, Jhones, Camila, Paluch, Andrew, Salvati, Mark, Janat-Amsbury, Margit, Eggert, Tobias, Kouros-Mehr, Hosein, Joshua, Anthony M., Aggarwal, Rahul Raj, De Bono, Johann S.

“…Abstract only TPS5088 Background: Lesions in mCRPC are typically immunologically cold. AMG 160 binds to PSMA on cancer cells and CD3 on T cells, leading to…”
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P-142 Meta-analysis of Baseline C-reactive Protein and Clinical Remission in Nine Crohnʼs Disease Clinical Trials by Yoonhee, Kim, Gottlieb, Klaus, Zhang, Li, Cooner, Freda, Lee, Jessica, Lee, Sue Chih, Insook Kim

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Su1083 Can Crohn's Disease Activity Index Differentiate Clinical Remission Induced by Placebo Versus Biologics Treatment? – Analyses of Six Clinical Trials for Crohn's Disease by Kim, Yoonhee, Mulberg, Andrew E, Lee, Jessica J, Gottlieb, Klaus, Cooner, Freda, Lee, Sue Chih H, Zhang, Li, Kim, Insook

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Modelling geographically referenced survival data with a cure fraction by Cooner, Freda, Banerjee, Sudipto, McBean, A Marshall

“…The emergence of geographical information systems and related softwares nowadays enables medical databases to incorporate the geographical information on…”
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Latent activation cure rate modeling for time -to -event data by Cooner, Freda W

“…With rapid improvements in medical treatment and health care, many data sets dealing with time to relapse or death now reveal a substantial portion of patients…”
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