DIA Japan Meeting: Thoughts on Global Collaboration Stephen P. Spielberg Editorial 30 December 2016 Pages: 7 - 7
Defining a Central Monitoring Capability: Sharing the Experience of TransCelerate BioPharma’s Approach, Part 2 Jacqueline GoughBrett WilsonHeather Achenbach Sponsored Special Section by TransCelerate BioPharma: Original Research Open access 30 December 2016 Pages: 8 - 14
Detecting Data Quality Issues in Clinical Trials: Current Practices and Recommendations David KnepperChristian FenskeAndy Lawton Sponsored Special Section by TransCelerate BioPharma: Original Research Open access 30 December 2016 Pages: 15 - 21
Interpreting Change in Scores on Patient-Reported Outcome Instruments Cheryl D. CoonJoseph C. Cappelleri Special Section on Clinical Outcome Assessments: Meeting Report 30 December 2016 Pages: 22 - 29
Establishing Equivalence of Electronic Clinician-Reported Outcome Measures Rebecca L. M. FullerCynthia W. McNamaraDavid S. Miller Special Section on Clinical Outcome Assessments: Original Research 30 December 2016 Pages: 30 - 36
Practical Considerations for the Use of Clinical Outcome Assessments (COAs) in Pediatric Clinical Research: Examples From Pediatric Gastroenterology Sarrit M. KovacsDiane M. Turner-BowkerJean Paty Special Section on Clinical Outcome Assessments: Meeting Report 30 December 2016 Pages: 37 - 43
Innovation of Medical Products: The Evolution of Regulatory Science, Research, and Education Per SpindlerKarin F. BachHans-Georg Eichler Global Perspectives: Commentary 30 December 2016 Pages: 44 - 48
Impact of Premium Rewards for the Promotion of Innovative Drug Discovery on the Japanese Pharmaceutical Market: An Analysis by Therapeutic Area Shoyo ShibataRyotaro UemuraTakeshi Suzuki Global Perspectives: Original Research 30 December 2016 Pages: 49 - 55
Factors That Affect the Acquisition of Reward Premiums for Promotion of Innovative Drug Discovery in Japan Shoyo ShibataRyotaro UemuraTakeshi Suzuki Global Perspectives: Original Research 30 December 2016 Pages: 56 - 65
Comparison of Treatment Effects Between US and Non-US Study Sites in Multiregional Alzheimer Disease Clinical Trials Jingyu Julia LuanRanjit ManiH. M. James Hung Global Perspectives: Original Research 30 December 2016 Pages: 66 - 73
Studies of Product Structure Adjustment Routes for China’s Pharmaceutical Industry: A View From the New Healthcare Reform Targets Wenhua LuoLihua SunGuangping Wang Global Perspectives: Original Research 30 December 2016 Pages: 74 - 81
Efficient Source Data Verification Using Statistical Acceptance Sampling: A Simulation Study Rutger M. van den BorBas J. OostermanKit C. B. Roes Global Perspectives: Original Research 30 December 2016 Pages: 82 - 90
Defining Regions in Multiregional Clinical Trials: An Analytical Approach to Considering Impact of Intrinsic and Extrinsic Factors Yoko TanakaAndrew BuchananBruce Binkowitz Global Perspectives: Original Research 30 December 2016 Pages: 91 - 100
Risk Management Plans in the European Union: Nonclinical Aspects Paul BaldrickLesley Reeve Global Perspectives: Analytical Report 30 December 2016 Pages: 101 - 105
Implementation of the European QRD Template in Package Leaflets of Centralized Approved Medicines Anna WolfJörg FuchsHarald G. Schweim Global Perspectives: Original Research 30 December 2016 Pages: 106 - 114
Extended Risk-Based Monitoring Model, On-Demand Query-Driven Source Data Verification, and Their Economic Impact on Clinical Trial Operations Vadim TantsyuraImogene McCanless DunnJules Mitchel Clinical Trials: Original Research 30 December 2016 Pages: 115 - 122
Benefits of Centralized ECG Reading in Clinical Oncology Studies Robert KleimanJeffrey LitwinJoel Morganroth Clinical Trials: Original Research 30 December 2016 Pages: 123 - 129
Incorporation of a Benefit-Risk Assessment Framework Into the Clinical Overview of Marketing Authorization Applications Anne WolkaMargaret WarnerRebecca Noel Product Safety: Original Research 23 December 2019 Pages: 130 - 134