1. Reporting of Randomized Clinical Trials Remains Far from Optimal

   • J. Rick Turner

   Editorial 30 December 2018 Pages: 137 - 139

2. Introduction to the Special Section for Sources of Safety Data and Statistical Strategies for Design and Analysis

   • Richard C. Zink

   Special Section: Sources of Safety Data and Statistical Strategies for Design and Analysis 30 December 2018 Pages: 140 - 140

3. Sources of Safety Data and Statistical Strategies for Design and Analysis: Clinical Trials

   • Richard C. Zink
   • Olga Marchenko
   • Qi Jiang

   Special Section: Sources of Safety Data and Statistical Strategies for Design and Analysis 30 December 2018 Pages: 141 - 158

4. Sources of Safety Data and Statistical Strategies for Design and Analysis: Postmarket Surveillance

   • Rima Izem
   • Matilde Sanchez-Kam
   • Yueqin Zhao

   Special Section: Sources of Safety Data and Statistical Strategies for Design and Analysis 30 December 2018 Pages: 159 - 169

5. Sources of Safety Data and Statistical Strategies for Design and Analysis: Real World Insights

   • Olga Marchenko
   • Estelle Russek-Cohen
   • Qi Jiang

   Special Section: Sources of Safety Data and Statistical Strategies for Design and Analysis 30 December 2018 Pages: 170 - 186

6. Sources of Safety Data and Statistical Strategies for Design and Analysis: Transforming Data Into Evidence

   • Haijun Ma
   • Estelle Russek-Cohen
   • Qi Jiang

   Special Section: Sources of Safety Data and Statistical Strategies for Design and Analysis 30 December 2018 Pages: 187 - 198

7. Extrapolation of Efficacy in Pediatric Drug Development and Evidence-based Medicine: Progress and Lessons Learned

   • Haihao Sun
   • Jean W. Temeck
   • Dianne Murphy

   Biostatistics: Original Research 30 December 2018 Pages: 199 - 205

8. The Rules of Engagement: CTTI Recommendations for Successful Collaborations Between Sponsors and Patient Groups Around Clinical Trials

   • Diane Bloom
   • Joel Beetsch
   • Jamie N. Roberts

   Clinical Trials: Original Research Open access 30 December 2018 Pages: 206 - 213

9. What to Know About Medicines With New Active Ingredients Approved in FY 2016/2016 in Japan and EU: A Brief Comparison of New Medicines Approved in Japan and the EU in 2016

   • Hideyuki Kondo
   • Agnès Saint-Raymond
   • Naoyuki Yasuda

   Global Perspectives: Commentary 30 December 2018 Pages: 214 - 219

10. Assessing the Financial Value of Patient Engagement: A Quantitative Approach from CTTI’s Patient Groups and Clinical Trials Project

    • Bennett Levitan
    • Kenneth Getz
    • Joseph DiMasi

    Patient Engagement: Original Research Open access 30 December 2018 Pages: 220 - 229

11. Design of Brand Names of Medicines Considering Subjects’ Preferences

    • Carla Maria Batista Ferreira Pires
    • Afonso Cavaco

    Patient Engagement: Original Research 30 December 2018 Pages: 230 - 235

12. Patient Drug Safety Reporting: Diabetes Patients’ Perceptions of Drug Safety and How to Improve Reporting of Adverse Events and Product Complaints

    • Puja Patel
    • David Spears
    • Michael Sacco

    Product Safety: Original Research 30 December 2018 Pages: 236 - 243

13. Translating New Science Into the Drug Review Process: The US FDA’s Division of Applied Regulatory Science

    • Rodney Rouse
    • Naomi Kruhlak
    • David G. Strauss

    Regulatory Science: Review Open access 30 December 2018 Pages: 244 - 255

14. Use of Proprietary Names by Prescribers for Generic Products

    • Vicky Borders-Hemphill
    • Irene Z. Chan
    • Grace Chai

    Regulatory Science: Original Research 30 December 2018 Pages: 256 - 260