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Advancing innovative clinical trials to efficiently deliver medicines to patients

Nature reviews. Drug discovery, 2022-08, Vol.21 (8), p.543-544

2022

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Platform Trial Designs in Drug Development: Umbrella Trials and Basket Trials

1, 2019

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Optimization of Pharmaceutical R&D Programs and Portfolios: Design and Investment Strategy

Antonijevic, Zoran

2015

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A framework for assessing the impact of accelerated approval

PloS one, 2022-06, Vol.17 (6), p.e0265712-e0265712

2022

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Optimization of Pharmaceutical R&d Programs and Portfolios: Design and Investment Strategy

Antonijevic, Zoran

2015., 2014

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Aiding the Adoption of Master Protocols by Optimizing Patient Engagement

Therapeutic innovation & regulatory science, 2023-11, Vol.57 (6), p.1136-1147

2023

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Statistical Design and Considerations of a Phase 3 Basket Trial for Simultaneous Investigation of Multiple Tumor Types in One Study

Statistics in biopharmaceutical research, 2016-07, Vol.8 (3), p.248-257

2016

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Sample Size Re-estimation Designs In Confirmatory Clinical Trials-Current State, Statistical Considerations, and Practical Guidance

Statistics in biopharmaceutical research, 2015-10, Vol.7 (4), p.309-321

2015

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The Impact of Adaptive Design on Portfolio Optimization

Therapeutic innovation & regulatory science, 2016-09, Vol.50 (5), p.615-619

Antonijevic, Zoran

2016

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Adaptive Clinical Trials

Clinical investigation, 2015-04, Vol.5 (4), p.353-354

Antonijevic, Zoran

2015

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Innovations in Clinical Development in Rare Diseases of Children and Adults: Small Populations and/or Small Patients

Paediatric drugs, 2022-11, Vol.24 (6), p.657-669

2022

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Efficient two-stage sequential arrays of proof of concept studies for pharmaceutical portfolios

Statistical methods in medical research, 2021-02, Vol.30 (2), p.396-410

2021

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A mathematical model for maximizing the value of phase 3 drug development portfolios incorporating budget constraints and risk

Statistics in medicine, 2013-05, Vol.32 (10), p.1763-1777

2013

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Planning for the Next Pandemic: Ethics and Innovation Today for Improved Clinical Trials Tomorrow

Statistics in biopharmaceutical research, 2022-01, Vol.14 (1), p.22-27

2022

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Impact of Dose Selection Strategies Used in Phase II on the Probability of Success in Phase III

Statistics in biopharmaceutical research, 2010-11, Vol.2 (4), p.469-486

2010

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A Practical Guide to Data Monitoring Committees in Adaptive Trials

Therapeutic innovation & regulatory science, 2014-05, Vol.48 (3), p.316-326

2014

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Optimizing Drug Development Programs: Type 2 Diabetes Case Study

Therapeutic Innovation & Regulatory Science, 2013-05, Vol.47 (3), p.363-374

2013

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Views on Emerging Issues Pertaining to Data Monitoring Committees for Adaptive Trials

Therapeutic Innovation & Regulatory Science, 2013-07, Vol.47 (4), p.495-502

2013

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Practical Considerations for a Two-Stage Confirmatory Adaptive Clinical Trial Design and Its Implementation: ADVENT Trial

Practical Considerations for Adaptive Trial Design and Implementation, p.383-411

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Dynamically Optimizing Budget Allocation for Phase 3 Drug Development Portfolios Incorporating Uncertainty in the Pipeline

Optimization of Pharmaceutical R&D Programs and Portfolios, p.181-200

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Adaptive and Model-Based Dose-Ranging Trials: Quantitative Evaluation and Recommendations. White Paper of the PhRMA Working Group on Adaptive Dose-Ranging Studies

Statistics in biopharmaceutical research, 2010-11, Vol.2 (4), p.435-454

2010

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Primary Site Independent Clinical Trials in Oncology

Platform Trial Designs in Drug Development, 2019, p.167-180

1, 2019

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Decision Analysis from the Perspectives of Single and Multiple Stakeholders

Platform Trial Designs in Drug Development, 2019, p.141-152

1, 2019

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Basket Trials at the Confirmatory Stage

Platform Trial Designs in Drug Development, 2019, p.37-54

1, 2019

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An Executive’s View of Value of Platform Trials

Platform Trial Designs in Drug Development, 2019, p.289-294

1, 2019

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Advancing innovative clinical trials to efficiently deliver medicines to patients

Platform Trial Designs in Drug Development: Umbrella Trials and Basket Trials

Optimization of Pharmaceutical R&D Programs and Portfolios: Design and Investment Strategy

A framework for assessing the impact of accelerated approval

Optimization of Pharmaceutical R&d Programs and Portfolios: Design and Investment Strategy

Aiding the Adoption of Master Protocols by Optimizing Patient Engagement

Statistical Design and Considerations of a Phase 3 Basket Trial for Simultaneous Investigation of Multiple Tumor Types in One Study

Sample Size Re-estimation Designs In Confirmatory Clinical Trials-Current State, Statistical Considerations, and Practical Guidance

The Impact of Adaptive Design on Portfolio Optimization

Adaptive Clinical Trials

Innovations in Clinical Development in Rare Diseases of Children and Adults: Small Populations and/or Small Patients

Efficient two-stage sequential arrays of proof of concept studies for pharmaceutical portfolios

A mathematical model for maximizing the value of phase 3 drug development portfolios incorporating budget constraints and risk

Planning for the Next Pandemic: Ethics and Innovation Today for Improved Clinical Trials Tomorrow

Impact of Dose Selection Strategies Used in Phase II on the Probability of Success in Phase III

A Practical Guide to Data Monitoring Committees in Adaptive Trials

Optimizing Drug Development Programs: Type 2 Diabetes Case Study

Views on Emerging Issues Pertaining to Data Monitoring Committees for Adaptive Trials

Practical Considerations for a Two-Stage Confirmatory Adaptive Clinical Trial Design and Its Implementation: ADVENT Trial

Dynamically Optimizing Budget Allocation for Phase 3 Drug Development Portfolios Incorporating Uncertainty in the Pipeline

Adaptive and Model-Based Dose-Ranging Trials: Quantitative Evaluation and Recommendations. White Paper of the PhRMA Working Group on Adaptive Dose-Ranging Studies

Primary Site Independent Clinical Trials in Oncology

Decision Analysis from the Perspectives of Single and Multiple Stakeholders

Basket Trials at the Confirmatory Stage

An Executive’s View of Value of Platform Trials

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