1. Advances in Clinical Outcome Assessments

   • Joseph C. Cappelleri
   • Stephen P. Spielberg

   Editorial 30 December 2015 Pages: 780 - 782

2. “Bring Your Own Device” (BYOD): The Future of Field-Based Patient-Reported Outcome Data Collection in Clinical Trials?

   • Chad Gwaltney
   • Stephen Joel Coons
   • ePRO Consortium

   Special Section on Clinical Outcome Assessments: Review 30 December 2015 Pages: 783 - 791

3. Considerations for Requiring Subjects to Provide a Response to Electronic Patient-Reported Outcome Instruments

   • Paul O’Donohoe
   • J. Jason Lundy
   • Patient-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

4. Optimizing Electronic Capture of Clinical Outcome Assessment Data in Clinical Trials: The Case of Patient-Reported Endpoints

   • Sarah Fleming
   • Alexandra I. Barsdorf
   • Patient-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

5. Advances in the Evaluation of Longitudinal Construct Validity of Clinical Outcome Assessments

   • Valerie Williams
   • Lori McLeod
   • Lauren Nelson

   Special Section on Clinical Outcome Assessments: Review 30 December 2015 Pages: 805 - 812

6. Unique Challenges in Development, Psychometric Evaluation, and Interpretation of Daily and Event Diaries as Endpoints in Clinical Trials

   • Adam Gater
   • Cheryl D. Coon
   • Cynthia Girman

   Special Section on Clinical Outcome Assessments: Review 30 December 2015 Pages: 813 - 821

7. Overcoming Organizational Challenges of Integrating Patient-Reported Outcomes in Oncology Clinical Trials

   • Ari Gnanasakthy
   • Carla DeMuro

   Special Section on Clinical Outcome Assessments: Analytical Report 30 December 2015 Pages: 822 - 830

8. An Overview and Analysis Regarding the Use of Adjudication Methods in EU and US Drug Approvals

   • Stephanie Krumholz-Bahner
   • Mimmo Garibbo
   • Beat E. Widler

   Regulatory Science: Original Research 30 December 2015 Pages: 831 - 839

9. Regulatory Definitions and Good Pharmacovigilance Practices in Social Media: Challenges and Recommendations

   • Paulami Naik
   • Thomas Umrath
   • Stella Stergiopoulos

   Regulatory Science: Review 30 December 2015 Pages: 840 - 851

10. Are Phase 3 Clinical Trials Really Becoming More Complex?

    • Harold E. Glass
    • Jeffrey J. DiFrancesco
    • Phuong Tran

    Product Development and Innovation: Original Research 30 December 2015 Pages: 852 - 860

11. Oligonucleotide-Based Drug Development: Considerations for Clinical Pharmacology and Immunogenicity

    • Jian Wang
    • Hoi-Kei Lon
    • David S. Pisetsky

    Product Development and Innovation: Review 30 December 2015 Pages: 861 - 868

12. An Examination of eClinical Technology Usage and CDISC Standards Adoption

    • Mary Jo Lamberti
    • Rebecca Kush
    • Kenneth A. Getz

    Product Development and Innovation: Original Research 30 December 2015 Pages: 869 - 876

13. Managing Team Innovation in the Research and Development (R&D) Organization: Critical Determinants of Team Effectiveness

    • Rajesh Krishna
    • Hongwei He

    Product Development and Innovation: Original Research 30 December 2015 Pages: 877 - 885

14. The Phosphate Content of Prescription Medication: A New Consideration

    • Richard A. Sherman
    • Supriya Ravella
    • Toros Kapoian

    Product Development and Innovation: Original Research 30 December 2015 Pages: 886 - 889

15. Improved Label and Liver Warning for Nonprescription Acetaminophen Products

    • R. William Soller
    • Tien Ho
    • James M. Lightwood

    Product Safety: Original Research 30 December 2015 Pages: 890 - 897

16. Quantitative Methods for the Identification of Signals for Individual Case Safety Reports in India

    • Kalaiselvan Vivekanandan
    • Arunabh Tripathi
    • Gyanendra Nath Singh

    Product Safety: Original Research 30 December 2015 Pages: 898 - 902

17. Risk-Based Monitoring: A Closer Statistical Look at Source Document Verification, Queries, Study Size Effects, and Data Quality

    • Vadim Tantsyura
    • Imogene McCanless Dunn
    • Jules Mitchel

    Clinical Trials: Original Research 30 December 2015 Pages: 903 - 910

18. The Relationship Between Development Start Lag and Approval Lag in Oncology Drug Development in Japan

    • Keitaro Nakajima
    • Ramzi Dagher
    • Koji Chiba

    Global Perspectives: Original Research 30 December 2015 Pages: 911 - 919

19. National Drug Information Sharing in the Thailand Health Care Supply Chain

    • Sophon Muangchoo
    • Duangpun Kritchanchai

    Global Perspectives: Original Research 30 December 2015 Pages: 920 - 928

20. Partnering With Patients in the Development and Lifecycle of Medicines: A Call for Action

    • Anton Hoos
    • James Anderson
    • Gervais Tougas

    Special Populations: Review Open access 30 December 2015 Pages: 929 - 939

21. Generational Value Differences Affecting Public Perceptions of and Willingness to Participate in Clinical Trials

    • April M. Nelson
    • Irwin G. Martin
    • Kenneth A. Getz

    Special Populations: Original Research 30 December 2015 Pages: 940 - 946

22. Clinical, Ethical, and Socioeconomic Considerations for Prescription Drug Use During Pregnancy in Women Suffering From Chronic Diseases

    • Victoria Tzouma
    • Mari Grepstad
    • Panos Kanavos

    Special Populations: Review 30 December 2015 Pages: 947 - 956

23. Statistical Considerations on the Evaluation of Imbalances of Adverse Events in Randomized Clinical Trials

    • Haijun Ma
    • Chunlei Ke
    • Steven Snapinn

    Biostatistics: Review 30 December 2015 Pages: 957 - 965