Reports to Independent Data Monitoring Committees: An Appeal for Clarity, Completeness, and Comprehensibility (English)
- New search for: Buhr, Kevin A.
- New search for: Downs, Matthew
- New search for: Rhorer, Janelle
- New search for: Bechhofer, Robin
- New search for: Wittes, Janet
- New search for: Buhr, Kevin A.
- New search for: Downs, Matthew
- New search for: Rhorer, Janelle
- New search for: Bechhofer, Robin
- New search for: Wittes, Janet
In:
Therapeutic Innovation & Regulatory Science
;
52
, 4
; 459-468
;
2018
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ISSN:
- Article (Journal) / Electronic Resource
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Title:Reports to Independent Data Monitoring Committees: An Appeal for Clarity, Completeness, and Comprehensibility
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Contributors:Buhr, Kevin A. ( author ) / Downs, Matthew ( author ) / Rhorer, Janelle ( author ) / Bechhofer, Robin ( author ) / Wittes, Janet ( author )
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Published in:Therapeutic Innovation & Regulatory Science ; 52, 4 ; 459-468
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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:2018
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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
- Further information on Basic classification
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Keywords:
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Classification:
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Source:
Table of contents – Volume 52, Issue 4
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.
- 397
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“Assessment of Pressor Effects of Drugs”—A New US FDA Draft Guidance for IndustryTurner, J. Rick et al. | 2018
- 400
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Advancing Drug Safety Through Prospective PharmacovigilancePitts, Peter J. / Le Louet, Hervé et al. | 2018
- 403
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A Proposal to Replace “SRL” as the Common Term for Medical Information Response DocumentsAlbano, Dominick / Ferri, Sviatlana et al. | 2018
- 405
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Response to “Use of Qualitative Data to Support Content Validity of Performance-Based Cognitive Outcome Assessments”Ropacki, Michael T. / Hannesdottir, Kristin / Hendrix, Suzanne / Gordon, Mark Forrest / Stephenson, Diane / Coons, Stephen Joel / Stern, Robert A. et al. | 2018
- 407
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Sample Size Determination for a 3-Treatment 3-Period Crossover Trial in Frequency DataLui, Kung-Jong et al. | 2018
- 416
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Strategic and Statistical Considerations on the QT Assessment of VolasertibWallenstein, Gudrun / Walter, Beate / Fritsch, Holger / Taube, Tillmann et al. | 2018
- 423
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Comparison of Dissolution Profiles: A Statistician’s PerspectiveHoffelder, Thomas et al. | 2018
- 430
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A Comparative Safety Profile Assessment of Oncolytic Virus Therapy Based on Clinical TrialsMatsuda, Takuma / Karube, Hiroyo / Aruga, Atsushi et al. | 2018
- 438
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Regional Differences During the ICH Regulatory Consultation Process Between the EU, US, and JapanTorqui, Aimad / Macau, Alina Mihaela et al. | 2018
- 442
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Optimal Anti-cancer Drug Profiles for Effective Penetration of the Anti-cancer Drug Market by Generic Drugs in JapanShibata, Shoyo / Matsushita, Maiko / Saito, Yoshimasa / Suzuki, Takeshi et al. | 2018
- 449
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The Regulatory Review Process in South Africa: Challenges and Opportunities for a New Improved SystemKeyter, Andrea / Gouws, Joey / Salek, Sam / Walker, Stuart et al. | 2018
- 459
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Reports to Independent Data Monitoring Committees: An Appeal for Clarity, Completeness, and ComprehensibilityBuhr, Kevin A. / Downs, Matthew / Rhorer, Janelle / Bechhofer, Robin / Wittes, Janet et al. | 2018
- 469
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Insights and Best Practices for Planning and Implementing Patient Advisory BoardsAnderson, Annick / Getz, Kenneth A. et al. | 2018
- 474
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Value of Developing Plain Language Summaries of Scientific and Clinical Articles: A Survey of Patients and PhysiciansPushparajah, Daphnee S. / Manning, Elizabeth / Michels, Erik / Arnaudeau-Bégard, Catherine et al. | 2018
- 482
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Direct-to-Consumer Genetic Testing: Finding a Clear Path ForwardSeward, Brendan et al. | 2018
- 489
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Factors That Facilitate Regulatory Approval for Drug-Device Combination Products in the European Union and United States of America: A Mixed Method Study of Industry ViewsMasterson, Fiona et al. | 2018
- 499
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Use Effectiveness of Medical Devices: A Case Study on the Deployment of Ultrasonographic DevicesAugustýnek, Martin / Laryš, Daniel / Kubíček, Jan / Marešová, Petra / Kuča, Kamil et al. | 2018
- 507
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Effective Partnering in Conducting Benefit-Risk Patient Preference Studies: Perspectives From a Patient Advocacy Organization, a Pharmaceutical Company, and Academic Stated-Preference ResearchersWolka, Anne M. / Fairchild, Angelyn O. / Reed, Shelby D. / Anglin, Greg / Johnson, F. Reed / Siegel, Michael / Noel, Rebecca et al. | 2018
- 514
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Pharma Opportunities and Risks Multiply as Regulatory Reform Remakes APAC: Expanded Accelerated Pathways Challenge Developer Value Story, Evidence Collection, and Market Access StrategiesGrignolo, Alberto / Mingping, Zhang et al. | 2018