Methods for Employing Information About Uncertainty of Ascertainment of Events in Clinical Trials (English)
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- New search for: Hung, H. M. James
- New search for: Stockbridge, Norman
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In:
Therapeutic Innovation & Regulatory Science
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55
, 1
; 197-211
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2020
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ISSN:
- Article (Journal) / Electronic Resource
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Title:Methods for Employing Information About Uncertainty of Ascertainment of Events in Clinical Trials
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Contributors:Chen, Yiming ( author ) / Lawrence, John ( author ) / Hung, H. M. James ( author ) / Stockbridge, Norman ( author )
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Published in:Therapeutic Innovation & Regulatory Science ; 55, 1 ; 197-211
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Publisher:
- New search for: Springer International Publishing
- New search for: Springer Nature
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Place of publication:[New York]
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Publication date:2020
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ISSN:
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ZDBID:
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DOI:
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Type of media:Article (Journal)
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Type of material:Electronic Resource
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Language:English
- New search for: 44.38 / 44.38
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Keywords:
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Source:
Table of contents – Volume 55, Issue 1
The tables of contents are generated automatically and are based on the data records of the individual contributions available in the index of the TIB portal. The display of the Tables of Contents may therefore be incomplete.
- 1
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FDA’s New Guidance for Industry Addressing Evaluation of the Safety of New Drugs for Improving Glycemic Control: A Case Study in Regulatory ScienceRick Turner, J. et al. | 2020
- 6
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Determining the Suitability of Registries for Embedding Clinical Trials in the United States: A Project of the Clinical Trials Transformation InitiativeMikita, J. Stephen / Mitchel, Jules / Gatto, Nicolle M. / Laschinger, John / Tcheng, James E. / Zeitler, Emily P. / Swern, Arlene S. / Flick, E. Dawn / Dowd, Christopher / Lystig, Theodore et al. | 2020
- 19
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Benchmarking Patient Recruitment and Retention PracticesLamberti, Mary Jo / Smith, Zachary / Henry, Rhonda / Howe, Deborah / Goodwin, Melanie / Williams, Amanda / Getz, Kenneth et al. | 2020
- 33
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Determining Minimum Wear Time for Mobile Sensor TechnologyMcCarthy, Marie / Bury, Denise P. / Byrom, Bill / Geoghegan, Cindy / Wong, Susan et al. | 2020
- 38
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Choosing a Mobile Sensor Technology for a Clinical Trial: Statistical Considerations, Developments and LearningsRussell, Colleen / McCarthy, Marie / Cappelleri, Joseph C. / Wong, Susan et al. | 2020
- 48
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Alternative New Mono-scaled Quantitative Benefit–Risk Assessment of Human Papillomavirus Vaccine in JapanMatsumoto, Tomoko / Matsumaru, Naoki / Scuffham, Paul / Neels, Pieter / Tsukamoto, Katsura et al. | 2020
- 56
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Spatial-Cluster Signal Detection in Medical Devices Using Likelihood Ratio Test MethodHu, Tingting / Huang, Lan / Xu, Jianjin / Tiwari, Ram et al. | 2020
- 65
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Policy of Multisource Drug Products in Latin America: Opportunities and Challenges on the Application of Bioequivalence In Vitro AssaysMiranda-Pérez de Alejo, Claudia / Aceituno Álvarez, Alexis / Mendes Lima Santos, Gustavo / Fernández Cervera, Mirna / Jung-Cook, Helgi / Cabrera-Pérez, Miguel Ángel et al. | 2020
- 82
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Factors Related to Conversion from Accelerated to Full Approval for Drugs Approved in the United States Between 2000 and 2016Irisawa, Koji / Kaneko, Masayuki / Narukawa, Mamoru et al. | 2020
- 90
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Bridging the Gap Between RCTs and RWE Through Endpoint SelectionLoCasale, Robert J. / Pashos, Chris L. / Gutierrez, Ben / Dreyer, Nancy A. / Collins, Toby / Calleja, Alan / Seewald, Michael J. / Plumb, Jonathan M. / Liwing, Johan / Tepie, Maurille Feudjo et al. | 2020
- 97
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Correction to: Bridging the Gap Between RCTs and RWE Through Endpoint SelectionLoCasale, Robert J. / Pashos, Chris L. / Gutierrez, Ben / Dreyer, Nancy A. / Collins, Toby / Calleja, Alan / Seewald, Michael J. / Plumb, Jonathan M. / Liwing, Johan / Tepie, Maurille Feudjo et al. | 2020
- 98
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Disagreements Between FDA and its Oncologic Drugs Advisory Committee (ODAC)Ayon Verduzco, Ariana / Yeboah, Kwadwo et al. | 2020
- 111
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Collection of Post-treatment PRO Data in Oncology Clinical TrialsLundy, J. Jason / Coon, Cheryl D. / Fu, An-Chen / Pawar, Vivek et al. | 2020
- 118
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Use of the Certificate for Pharmaceutical Products (CPP) in 18 Maturing Pharmaceutical Markets: Comparing Agency Guidelines with Company PracticeRodier, Céline / Bujar, Magda / McAuslane, Neil / Patel, Prisha / Liberti, Lawrence et al. | 2020
- 129
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Predicting Regulatory Product Approvals Using a Proposed Quantitative Version of FDA’s Benefit–Risk Framework to Calculate Net-Benefit Score and Benefit–Risk RatioSun, Stephen / Heske, Suzanne / Mercadel, Melanie / Wimmer, Jean et al. | 2020
- 138
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Rebranding Gout: Could a Name Change for Gout Improve Adherence to Urate-Lowering Therapy?Coleshill, Matthew J. / Aung, Eindra / Carland, Jane E. / Faasse, Kate / Stocker, Sophie / Day, Richard O. et al. | 2020
- 142
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Exploring Completeness of Adverse Event Reports as a Tool for Signal Detection in PharmacovigilanceLee, Inyoung / Jokinen, Jeremy D. / Crawford, Stephanie Y. / Calip, Gregory S. / Kilpatrick, Ryan D. / Lee, Todd A. et al. | 2020
- 152
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Mobile Applications (Apps) to Support the Hepatitis C Treatment: A Systematic Search in App StoresRodrigues, Aline Teotonio / Sousa, Camila Tavares / Pereira, João / Figueiredo, Isabel Vitória / Lima, Tácio de Mendonça et al. | 2020
- 163
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The CECMED Office of Innovation: A Core Initiative to Bolster Novel Pharmaceutical Products-The Cuban ApproachRomeu, Belkis / Perez Cristiá, Rafael et al. | 2020
- 170
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FDA’s Benefit–Risk Framework for Human Drugs and Biologics: Role in Benefit–Risk Assessment and Analysis of Use for Drug ApprovalsLackey, Leila / Thompson, Graham / Eggers, Sara et al. | 2020
- 180
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Feasibility of a Hybrid Risk-Adapted Monitoring System in Investigator-Sponsored Trials in CancerKim, Sinae / Kim, YunJung / Hong, YoungLan / Kim, YunOk / Lim, Joon Seo / Lee, JiSung / Kim, Tae Won et al. | 2020
- 190
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Using Statistical Modeling for Enhanced and Flexible Pharmacovigilance Audit Risk Assessment and PlanningZou, Min / Barmaz, Yves / Preovolos, Melissa / Popko, Leszek / Ménard, Timothé et al. | 2020
- 197
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Methods for Employing Information About Uncertainty of Ascertainment of Events in Clinical TrialsChen, Yiming / Lawrence, John / Hung, H. M. James / Stockbridge, Norman et al. | 2020
- 212
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Drivers of Start-Up Delays in Global Randomized Clinical TrialsLai, Jennifer / Forney, Leila / Brinton, Daniel L. / Simpson, Kit N. et al. | 2020
- 228
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Impact of Real-World Data on Market Authorization, Reimbursement Decision & Price NegotiationPulini, Alfredo Aram / Caetano, Gabriela Martins / Clautiaux, Henri / Vergeron, Laure / Pitts, Peter J. / Katz, Gregory et al. | 2020
- 239
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Unicorn Poo and Blessed Waters: COVID-19 Quackery and FDA Warning LettersBramstedt, Katrina A. et al. | 2020
- 245
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Ensuring Black Lives Matter in Drug DevelopmentFitzsimmons, William E. / Okorie-Awé, Clara et al. | 2020
- 247
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Patient Contribution to the Development and Safe Use of Medicines During the Covid-19 PandemicPitts, Peter J. / Houÿez, François et al. | 2020