1. Statistical Practices of Safety Monitoring: An Industry Survey

   • Michael W. Colopy
   • Robert Gordon
   • Greg Ball

   Biostatistics: Analytical Report 23 December 2019 Pages: 293 - 300

2. How 4 Companies Became One: Co-development Under an Outsourced Model With Focus on Phase 3 Analysis and Reporting Deliverables

   • Susan Huyck
   • Gregory Golm
   • Tarra Irvin

   Clinical Trials: Original Article 23 December 2019 Pages: 301 - 306

3. Evaluating the Completeness of ClinicalTrials.gov

   • Stella Stergiopoulos
   • Kenneth A. Getz
   • Christine Blazynski

   Clinical Trials: Original Article 23 December 2019 Pages: 307 - 317

4. Perceived Burden of Completion of Patient-Reported Outcome Measures in Clinical Trials: Results of a Preliminary Study

   • Serge Bodart
   • Bill Byrom
   • ePRO Consortium

   Clinical Trials: Original Article 23 December 2019 Pages: 318 - 323

5. Possible Causes of Failing to Meet Primary Endpoints: A Systematic Review of Randomized Controlled Phase 3 Clinical Trials in Patients With Non–Small Cell Lung Cancer

   • Mitsugu Ikeda
   • Tatsuya Ochibe
   • Masahiro Tohkin

   Clinical Trials: Original Article 23 December 2019 Pages: 324 - 331

6. Pharma Collaboration for Transparent Medical Information (phactMI) Benchmark Study: Trends, Drivers, Success Factors, and Value of Globalization in Medical Information

   • Suzana A. Giffin
   • Richa Shah
   • Dominick Albano

   Medical Communications: Original Article 23 December 2019 Pages: 332 - 339

7. US Medical Information Websites Benchmarking: How Is the Industry Fairing in Usability?

   • Etienne Paquette-Lemieux
   • Steven Hays
   • Rania Gaspo

   Medical Communications: Original Article 23 December 2019 Pages: 340 - 348

8. Incorporating Patient Advocates in Oncology Clinical Development: Lessons Learned From a Novel Pilot Program

   • Wendy Selig
   • Ian Banks
   • Lisa Schlager

   Patient Engagement: Commentary 23 December 2019 Pages: 349 - 353

9. Validation Master Plans: Progress of Implementation in the Pharmaceutical Industry

   • Clare Elser
   • Frances J. Richmond

   Product Safety: Original Article 23 December 2019 Pages: 354 - 363

10. Expediting Drug Development: FDA’s New Regenerative Medicine Advanced Therapy Designation

    • Annegret Vaggelas
    • Diane Seimetz

    Regulatory Science: Analytical Report 23 December 2019 Pages: 364 - 373

11. Practical Issues in Clinical Inspection Process

    • Fuyu Song
    • Xue Qian
    • Minghuang Hong

    Regulatory Science: Original Article 23 December 2019 Pages: 374 - 380

12. Special Considerations for Proprietary Name Review: Focus on Products That May Be Prescribed “As Directed”

    • Briana B. Rider
    • Hina Mehta
    • Lubna Merchant

    Regulatory Science: Original Article 23 December 2019 Pages: 381 - 386

13. Assessing Treatment Effects That Capture Disease Burden in Serious Chronic Diseases

    • Mouna Akacha
    • Bruce Binkowitz
    • Norman Stockbridge

    Regulatory Science: Review Article 23 December 2019 Pages: 387 - 397

14. Improving Drug Development and Patient Access With the Right People, Processes, and Culture: What Needs to Happen Right Now to Bring Better Medicines to the Patients Who Need Them

    • Alberto Grignolo
    • Albert Siu

    Regulatory Science: Analytical Report Open access 23 December 2019 Pages: 398 - 402

15. Evidence-Based Valuation in Oncology: Lessons Learned from a Case Study

    • John J. Doyle
    • Emily Hawryluk
    • Brian Wood

    Value and Access: Analytical Report Open access 23 December 2019 Pages: 403 - 411