Therapeutic Innovation & Regulatory Science
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Publication Venue For
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A Framework for Safety Evaluation Throughout the Product Development Life-Cycle..
54:821-830.
2020
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Legal, Regulatory, and Practical Issues to Consider When Adopting Decentralized Clinical Trials: Recommendations From the Clinical Trials Transformation Initiative..
54:779-787.
2020
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Determining the Suitability of Registries for Embedding Clinical Trials in the United States: A Project of the Clinical Trials Transformation Initiative.
2020
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Designing, Conducting, Monitoring, and Analyzing Data from Pragmatic Randomized Clinical Trials: Proceedings from a Multi-stakeholder Think Tank Meeting.
2020
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Methodological and Regulatory Considerations for Updated Guidance on the Pressor Effects of Drugs.
2020
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Practical Issues in Clinical Inspection Process..
53:374-380.
2019
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Defining Efficacy Estimands in Clinical Trials: Examples Illustrating ICH E9(R1) Guidelines..
2168479019841316.
2019
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Choosing Estimands in Clinical Trials: Putting the ICH E9(R1) Into Practice..
2168479019838827.
2019
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Developing and Implementing Performance Outcome Assessments: Evidentiary, Methodologic, and Operational Considerations..
53:146-153.
2019
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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 Researchers..
52:507-513.
2018
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Assessing the Financial Value of Patient Engagement: A Quantitative Approach from CTTI's Patient Groups and Clinical Trials Project..
52:220-229.
2018
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Patient Engagement at a Tipping Point-The Need for Cultural Change Across Patient, Sponsor, and Regulator Stakeholders: Insights From the DIA Conference, "Patient Engagement in Benefit Risk Assessment Throughout the Life Cycle of Medical Products"..
50:546-553.
2016
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Oligonucleotide-Based Drug Development: Considerations for Clinical Pharmacology and Immunogenicity..
49:861-868.
2015
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Applying Regulatory Science to Develop Safe and Effective Medicines for Neonates: Report of the US Food and Drug Administration First Annual Neonatal Scientific Workshop, October 28-29, 2014..
49:623-631.
2015
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Cardiac Safety Research Consortium (CSRC): Cardiovascular Safety and Adverse Event Case Report Forms..
49:511-513.
2015
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Industry Practices for Expedited Reporting to Investigators Conducting Research Under an IND..
48:741-748.
2014
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Optimizing Expedited Safety Reporting for Drugs and Biologics Subject to an Investigational New Drug Application..
48:200-207.
2014