Advances in Clinical Outcome Assessments Joseph C. CappelleriStephen P. Spielberg Editorial 30 December 2015 Pages: 780 - 782
“Bring Your Own Device” (BYOD): The Future of Field-Based Patient-Reported Outcome Data Collection in Clinical Trials? Chad GwaltneyStephen Joel CoonsePRO Consortium Special Section on Clinical Outcome Assessments: Review 30 December 2015 Pages: 783 - 791
Considerations for Requiring Subjects to Provide a Response to Electronic Patient-Reported Outcome Instruments Paul O’DonohoeJ. Jason LundyPatient-Reported Outcome (PRO) Consortium and the ePRO Consortium at the Critical Path Institute Special Section on Clinical Outcome Assessments: Analytical Report 30 December 2015 Pages: 792 - 796
Optimizing Electronic Capture of Clinical Outcome Assessment Data in Clinical Trials: The Case of Patient-Reported Endpoints Sarah FlemingAlexandra I. BarsdorfPatient-Reported Outcome (PRO) Consortium and the ePRO Consortium at the Critical Path Institute Special Section on Clinical Outcome Assessments: Analytical Report 30 December 2015 Pages: 797 - 804
Advances in the Evaluation of Longitudinal Construct Validity of Clinical Outcome Assessments Valerie WilliamsLori McLeodLauren Nelson Special Section on Clinical Outcome Assessments: Review 30 December 2015 Pages: 805 - 812
Unique Challenges in Development, Psychometric Evaluation, and Interpretation of Daily and Event Diaries as Endpoints in Clinical Trials Adam GaterCheryl D. CoonCynthia Girman Special Section on Clinical Outcome Assessments: Review 30 December 2015 Pages: 813 - 821
Overcoming Organizational Challenges of Integrating Patient-Reported Outcomes in Oncology Clinical Trials Ari GnanasakthyCarla DeMuro Special Section on Clinical Outcome Assessments: Analytical Report 30 December 2015 Pages: 822 - 830
An Overview and Analysis Regarding the Use of Adjudication Methods in EU and US Drug Approvals Stephanie Krumholz-BahnerMimmo GaribboBeat E. Widler Regulatory Science: Original Research 30 December 2015 Pages: 831 - 839
Regulatory Definitions and Good Pharmacovigilance Practices in Social Media: Challenges and Recommendations Paulami NaikThomas UmrathStella Stergiopoulos Regulatory Science: Review 30 December 2015 Pages: 840 - 851
Are Phase 3 Clinical Trials Really Becoming More Complex? Harold E. GlassJeffrey J. DiFrancescoPhuong Tran Product Development and Innovation: Original Research 30 December 2015 Pages: 852 - 860
Oligonucleotide-Based Drug Development: Considerations for Clinical Pharmacology and Immunogenicity Jian WangHoi-Kei LonDavid S. Pisetsky Product Development and Innovation: Review 30 December 2015 Pages: 861 - 868
An Examination of eClinical Technology Usage and CDISC Standards Adoption Mary Jo LambertiRebecca KushKenneth A. Getz Product Development and Innovation: Original Research 30 December 2015 Pages: 869 - 876
Managing Team Innovation in the Research and Development (R&D) Organization: Critical Determinants of Team Effectiveness Rajesh KrishnaHongwei He Product Development and Innovation: Original Research 30 December 2015 Pages: 877 - 885
The Phosphate Content of Prescription Medication: A New Consideration Richard A. ShermanSupriya RavellaToros Kapoian Product Development and Innovation: Original Research 30 December 2015 Pages: 886 - 889
Improved Label and Liver Warning for Nonprescription Acetaminophen Products R. William SollerTien HoJames M. Lightwood Product Safety: Original Research 30 December 2015 Pages: 890 - 897
Quantitative Methods for the Identification of Signals for Individual Case Safety Reports in India Kalaiselvan VivekanandanArunabh TripathiGyanendra Nath Singh Product Safety: Original Research 30 December 2015 Pages: 898 - 902
Risk-Based Monitoring: A Closer Statistical Look at Source Document Verification, Queries, Study Size Effects, and Data Quality Vadim TantsyuraImogene McCanless DunnJules Mitchel Clinical Trials: Original Research 30 December 2015 Pages: 903 - 910
The Relationship Between Development Start Lag and Approval Lag in Oncology Drug Development in Japan Keitaro NakajimaRamzi DagherKoji Chiba Global Perspectives: Original Research 30 December 2015 Pages: 911 - 919
National Drug Information Sharing in the Thailand Health Care Supply Chain Sophon MuangchooDuangpun Kritchanchai Global Perspectives: Original Research 30 December 2015 Pages: 920 - 928
Partnering With Patients in the Development and Lifecycle of Medicines: A Call for Action Anton HoosJames AndersonGervais Tougas Special Populations: Review Open access 30 December 2015 Pages: 929 - 939
Generational Value Differences Affecting Public Perceptions of and Willingness to Participate in Clinical Trials April M. NelsonIrwin G. MartinKenneth A. Getz Special Populations: Original Research 30 December 2015 Pages: 940 - 946
Clinical, Ethical, and Socioeconomic Considerations for Prescription Drug Use During Pregnancy in Women Suffering From Chronic Diseases Victoria TzoumaMari GrepstadPanos Kanavos Special Populations: Review 30 December 2015 Pages: 947 - 956
Statistical Considerations on the Evaluation of Imbalances of Adverse Events in Randomized Clinical Trials Haijun MaChunlei KeSteven Snapinn Biostatistics: Review 30 December 2015 Pages: 957 - 965
