1. A Model for the Role of TIRS in Helping to Develop and Validate Best Practices Across Clinical Trial Management

   • Stephen P. Spielberg

   Editorial 30 December 2014 Pages: 528 - 528

2. Defining a Central Monitoring Capability: Sharing the Experience of TransCelerate BioPharma’s Approach, Part 1

   • Brett Wilson
   • Tom Provencher
   • Andy Lawton

   Sponsored Special Section by TransCelerate BioPharma Open access 30 December 2014 Pages: 529 - 535

3. Technology Considerations to Enable the Risk-Based Monitoring Methodology

   • Shelly Barnes
   • Nareen Katta
   • Thomas Verish

   Sponsored Special Section by TransCelerate BioPharma Open access 30 December 2014 Pages: 536 - 545

4. Building an Integrated Early Clinical Development Platform to Improve the Path to Proof of Concept

   • Oren Cohen
   • Frederic Sax

   Commentaries 30 December 2014 Pages: 546 - 551

5. Just Say No?

   • Mary Ross Southworth
   • Norman Stockbridge

   Commentaries 30 December 2014 Pages: 552 - 553

6. FDA Analysis of Atorvastatin Products Refutes Report of Methyl Ester Impurities

   • Janet Woodcock
   • Mansoor A. Khan

   Commentaries 30 December 2014 Pages: 554 - 556

7. Promotion of Patient-Reported Outcome Label Claims Based on Nonprimary Endpoints

   • Ari Gnanasakthy
   • Ashlyn Sadrick
   • Carla DeMuro

   Patient Focus 30 December 2014 Pages: 557 - 563

8. Structured Approaches to Benefit-Risk Assessment: A Case Study and the Patient Perspective

   • Bennett Levitan
   • Lawrence D. Phillips
   • Stuart Walker

   Patient Focus 30 December 2014 Pages: 564 - 573

9. Patient Comprehension of Medication Guides for Asthma and Chronic Obstructive Pulmonary Disease Medications

   • Rachael L. DiSantostefano
   • Melissa Beck
   • David A. Stempel

   Patient Focus 30 December 2014 Pages: 574 - 582

10. Diabetic Patients’ Knowledge of Their Disease, Therapeutic Goals, and Self-management: Association With Goal Attainment at Dessie Referral Hospital, Ethiopia

    • Teshager Aklilu
    • Desta Hiko
    • Nezif Hussein Dekema

    Patient Focus 30 December 2014 Pages: 583 - 591

11. A New Method for the Comparison of Powers of Noninferiority Exact Tests for the Difference of Proportions

    • David Sotres-Ramos
    • Félix Almendra-Arao
    • Emmanuel Anguiano-Mondragón

    Statistics 30 December 2014 Pages: 592 - 600

12. Novel Statistical Designs for Phase I/II and Phase II Clinical Trials With Dose-Finding Objectives

    • Oleksandr Sverdlov
    • Weng Kee Wong

    Statistics 30 December 2014 Pages: 601 - 612

13. Statistical Properties of Large Sample Tests for Dose Content Uniformity

    • Meiyu Shen
    • Yi Tsong
    • Xiaoyu Dong

    Statistics 30 December 2014 Pages: 613 - 622

14. The Imperfect Intellectual Bridge Between a Master Medicinal Product and Its Associated Custom-Made Medicinal Products

    • John D. Johnston
    • Peter Feldschreiber

    Translational Medicine 30 December 2014 Pages: 623 - 627

15. Site Characteristics Influencing the Translation of Clinical Research Into Clinical Practice

    • Marie Smed
    • Kenneth A. Getz

    Translational Medicine 30 December 2014 Pages: 628 - 634

16. Approval Status and Regulatory Actions for Radiopharmaceuticals in the United States and Japan

    • Nobuyuki Hanamura
    • Atsushi Aruga

    International Regulatory Science 30 December 2014 Pages: 635 - 643

17. Exploring Ethnic Differences in Toxicity in Early-Phase Clinical Trials for Oncology Drugs

    • Takashi Ogura
    • Satoshi Morita
    • Tsutomu Urano

    International Regulatory Science 30 December 2014 Pages: 644 - 650

18. Responsible Parties—Is It Time to Clean Up Your ACTs?

    • Frances Vakarcs

    Clinical Trials 30 December 2014 Pages: 651 - 657

19. FDA Studies New Strategies for Presentation of Patient Information

    • Bryon M. Pearsall
    • Richardae Araojo

    Letter to the Editor Open access 30 December 2014 Pages: NP3 - NP4