Strategies for dealing with fraud in clinical trials von Herson, Jay

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Cardiovascular adverse events in oncology trials: understanding and appreciating the differences between clinical trial data and real-world reports von Ewer, Michael S, Herson, Jay

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Clinical trial preparations for the next pandemic von Herson, Jay

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Correlation between week 24 trastuzumab-dkst response and week 48 progression-free survival: the HERITAGE trial von Rugo, Hope S., Pennella, Eduardo J., Gopalakrishnan, Unmesh, Hernandez-Bronchud, Miguel, Herson, Jay, Koch, Hans Friedrich, Loganathan, Subramanian, Deodhar, Sarika, Marwah, Ashwani, Manikhas, Alexey, Bondarenko, Igor, Parra, Joseph D., Abesamis-Tiambeng, Maria Luisa T., Akewanlop, Charuwan, Vynnychenko, Ihor, Sriuranpong, Virote, Roy, Sirshendu, Yanez Ruiz, Eduardo Patricio, Barve, Abhijit, Waller, Cornelius F.

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Cardiac Monitoring Guidelines in Clinical Trials and Post-Approval Surveillance for Patients Exposed to Anticancer Treatments: Do the Data Support the Recommendations? von Ewer, Michael S, Palaskas, Nicolas L, Herson, Jay

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Structure-Based Design of an Osteoclast-Selective, Nonpeptide Src Homology 2 Inhibitor with in vivo Antiresorptive Activity von Shakespeare, William, Yang, Michael, Bohacek, Regine, Cerasoli, Franklin, Stebbins, Karin, Sundaramoorthi, Raji, Azimioara, Mihai, Vu, Chi, Pradeepan, Selvi, Metcalf, Chester, Haraldson, Chad, Merry, Taylor, Dalgarno, David, Narula, Surinder, Hatada, Marcos, Lu, Xiaode, van Schravendijk, Marie Rose, Adams, Susan, Violette, Shelia, Smith, Jeremy, Guan, Wei, Bartlett, Catherine, Herson, Jay, Iuliucci, John, Weigele, Manfred, Sawyer, Tomi

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Effect of a Proposed Trastuzumab Biosimilar Compared With Trastuzumab on Overall Response Rate in Patients With ERBB2 (HER2)–Positive Metastatic Breast Cancer: A Randomized Clinica... von Rugo, Hope S, Barve, Abhijit, Waller, Cornelius F, Hernandez-Bronchud, Miguel, Herson, Jay, Yuan, Jinyu, Sharma, Rajiv, Baczkowski, Mark, Kothekar, Mudgal, Loganathan, Subramanian, Manikhas, Alexey, Bondarenko, Igor, Mukhametshina, Guzel, Nemsadze, Gia, Parra, Joseph D, Abesamis-Tiambeng, Maria Luisa T, Baramidze, Kakhaber, Akewanlop, Charuwan, Vynnychenko, Ihor, Sriuranpong, Virote, Mamillapalli, Gopichand, Ray, Sirshendu, Yanez Ruiz, Eduardo P, Pennella, Eduardo

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Global Drug Safety: 2030 von Herson, Jay

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Aggregate IND Safety Reporting for Smaller Companies and Programs von Ball, Greg, Li, Mengchun, Buchanan, Jim, Hendrickson, Barbara, Zink, Richard C., Snapinn, Steve, Herson, Jay

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False Positive Cardiotoxicity Events in Cancer-Related Clinical Trials: Risks Related to Imperfect Noninvasive Parameters von Ewer, Michael S., Herson, Jay

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Employment, Entrepreneurship, Innovation: 2030 von Herson, Jay

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Coordinating Data Monitoring Committees and Adaptive Clinical Trial Designs von Herson, Jay

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Final overall survival analysis of the phase 3 HERITAGE study demonstrates equivalence of trastuzumab-dkst to trastuzumab in HER2-positive metastatic breast cancer von Rugo, Hope S., Pennella, Eduardo J., Gopalakrishnan, Unmesh, Hernandez-Bronchud, Miguel, Herson, Jay, Koch, Hans Friedrich, Loganathan, Subramanian, Deodhar, Sarika, Marwah, Ashwani, Manikhas, Alexey, Bondarenko, Igor, Mukhametshina, Guzel, Nemsadze, Gia, Parra, Joseph D., Abesamis-Tiambeng, Maria Luisa T., Baramidze, Kakhaber, Akewanlop, Charuwan, Vynnychenko, Ihor, Sriuranpong, Virote, Mamillapalli, Gopichand, Roy, Sirshendu, Yanez Ruiz, Eduardo Patricio, Barve, Abhijit, Fuentes-Alburo, Adolfo, Waller, Cornelius F.

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A Phase 2/3, Multicenter, Randomized, Double-Masked, 2-Year Trial of Pegaptanib Sodium for the Treatment of Diabetic Macular Edema von Sultan, Marla B., MD, MBA, Zhou, Duo, MD, MS, Loftus, Jane, MSc, BSc, Dombi, Theresa, PhD, Ice, Kathleen S., PhD

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Biosimilar trastuzumab-dkst monotherapy versus trastuzumab monotherapy after combination therapy: Toxicity, efficacy, and immunogenicity from the phase 3 Heritage trial von Manikhas, Aleksei, Pennella, Eduardo J., Bondarenko, Igor, Mukhametshina, Guzel, Abesamis-Tiambeng, Maria Luisa T., Akewanlop, Charuwan, Vynnychenko, Ihor, Sriuranpong, Virote, Ray, Sirshendu, Waller, Cornelius F., Hernandez Bronchud, Miguel, Herson, Jay, Loganathan, Subramanian, Barve, Abhijit, Rugo, Hope S.

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Biosimilar trastuzumab-dkst monotherapy versus trastuzumab monotherapy after combination therapy: Final overall survival (OS) from the phase III HERITAGE Trial von Waller, Cornelius F., Manikhas, Aleksei, Pennella, Eduardo J., Bondarenko, Igor, Mukhametshina, Guzel, Tiambeng, Maria Luisa Abesanis, Akewanlop, Charuwan, Vynnychenko, Ihor, Sriuranpong, Virote, Ray, Sirshendu, Hernandez-Bronchud, Miguel, Herson, Jay, Parra, Joseph D., Nemsadze, Gia, Gopalakrishnan, Unmesh, Loganathan, Subramanian, Muniz, Rafael, Barve, Abhijit, Rugo, Hope S.

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Heritage: A phase III safety and efficacy trial of the proposed trastuzumab biosimilar Myl-1401O versus Herceptin von Rugo, Hope S., Barve, Abhijit, Waller, Cornelius F., Hernandez-Bronchud, Miguel, Herson, Jay, Yuan, Jinyu, Manikhas, Alexey, Bondarenko, Igor, Mukhametshina, Guzel, Nemsadze, Gia, Parra, Joseph D., Tiambeng, Maria Luisa T. Abesamis, Baramidze, Kakhaber, Akewanlop, Charuwan, Vynnychenko, Ihor, Sriuranpong, Virote, Manillapalli, Gopichand, Ray, Sirshendu, Yanez Ruiz, Eduardo Patricio, Pennella, Eduardo J.

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Heritage: A phase III safety and efficacy trial of the proposed trastuzumab biosimilar Myl-1401O versus Herceptin von Rugo, Hope S., Barve, Abhijit, Waller, Cornelius F., Hernandez-Bronchud, Miguel, Herson, Jay, Yuan, Jinyu, Manikhas, Alexey, Bondarenko, Igor, Mukhametshina, Guzel, Nemsadze, Gia, Parra, Joseph D., Tiambeng, Maria Luisa T. Abesamis, Baramidze, Kakhaber, Akewanlop, Charuwan, Vynnychenko, Ihor, Sriuranpong, Virote, Manillapalli, Gopichand, Ray, Sirshendu, Yanez Ruiz, Eduardo Patricio, Pennella, Eduardo J.

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Data monitoring boards in the pharmaceutical industry von Herson, Jay

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Predictive Probability Early Termination Plans For Phase II Clinical Trials von Herson, Jay

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