1. DIA Then and Now: A Half-Century Odyssey

   • J. Rick Turner

   Editorial 30 December 2017 Pages: 531 - 533

2. Improving Investigative Site Contact Options on Clinical Trial Registries: Making It Easier for Patients to Find Clinical Trials

   • Christa Patterson Polidori
   • Mandy S. Su
   • Joseph Yoder

   Sponsored Special Section by TransCelerate BioPharma: Original Research Open access 30 December 2017 Pages: 534 - 541

3. Improving Information Exchange with Clinical Trial Participants: A Proposal for Industry

   • Julie Dietrich
   • Jeannine Alivojvodic
   • Kelsey Jakee

   Sponsored Special Section by TransCelerate BioPharma: Original Research Open access 30 December 2017 Pages: 542 - 550

4. Optimizing the Use of Electronic Data Sources in Clinical Trials: The Technology Landscape

   • Ed Kellar
   • Susan Bornstein
   • Brett Wilson

   Sponsored Special Section by TransCelerate BioPharma: Original Research Open access 30 December 2017 Pages: 551 - 567

5. The Case for a Bayesian Approach to Benefit-Risk Assessment: Overview and Future Directions

   • Maria J. Costa
   • Weili He
   • Carl Di Casoli

   Biostatistics: Analytical Report 30 December 2017 Pages: 568 - 574

6. Baseline Assessment of a Global Clinical Investigator Landscape Poised for Structural Change

   • Kenneth Getz
   • Carrie Brown
   • Cerdi Beltre

   Clinical Trials: Original Research 30 December 2017 Pages: 575 - 581

7. Quantitative Assessment of Premium Rates for Clinical Usefulness in New Drug Price Calculation in Japan

   • Akane Takayama
   • Eriko Kobayashi
   • Mamoru Narukawa

   Global Perspectives: Original Research 30 December 2017 Pages: 582 - 588

8. Investigation of the Factors Affecting Risk-Based Quality Management of Investigator-Initiated Investigational New-Drug Trials for Unapproved Anticancer Drugs in Japan

   • Tomohisa Sudo
   • Akihiro Sato

   Global Perspectives: Original Research 30 December 2017 Pages: 589 - 596

9. Drugs Targeted for Price Cutting in Japan: The Case of Price Revisions Based on the Divergence of Official Versus Delivery Prices

   • Daigo Fukumoto
   • Ai Tsuyuki
   • Takeshi Suzuki

   Global Perspectives: Original Research 30 December 2017 Pages: 597 - 603

10. Comparison of New Drug Accessibility and Price Between Japan and Major European Countries

    • Akane Takayama
    • Mamoru Narukawa

    Global Perspectives: Original Research 30 December 2017 Pages: 604 - 611

11. Improving Patient Involvement in Medicines Research and Development: A Practical Roadmap

    • Jan Geissler
    • Bettina Ryll
    • Mary Uhlenhopp

    Patient Engagement: Original Research 30 December 2017 Pages: 612 - 619

12. Import Testing: An Outdated Practice? Opportunities for Improved Access to Safe and Efficient Medicines

    • Joerg H. O. Garbe
    • Maria G. Jacobs
    • Stephan K. Rönninger

    Product Safety: Review 30 December 2017 Pages: 620 - 624

13. On a Stepwise Quantitative Approach for Benefit-Risk Assessment

    • Weili He
    • Yaxuan Sun
    • Sabrina Wan

    Regulatory Science: Analytical Report 30 December 2017 Pages: 625 - 634

14. The Benefit-Risk Assessment of Medicines: Experience of a Consortium of Medium-Sized Regulatory Authorities

    • Neil McAuslane
    • James Leong
    • Stuart Walker

    Regulatory Science: Original Research 30 December 2017 Pages: 635 - 644

15. Best Practices for Submitting Promotional 2253 Submissions in the New Module 1 Specification

    • Sandra Krogulski

    Regulatory Science: Original Research 30 December 2017 Pages: 645 - 650

16. Analysis of Review Times for Recent 505(b)(2) Applications

    • Sharon Sakai
    • Joseph A. DiMasi
    • Kenneth A. Getz

    Regulatory Science: Original Research 30 December 2017 Pages: 651 - 656