1. 2015 and Beyond

   • Stephen P. Spielberg

   Editorial 30 December 2015 Pages: 8 - 8

2. Patient Engagement by Pharma—Why and How? A Framework for Compliant Patient Engagement

   • Lode Dewulf

   Policy 30 December 2015 Pages: 9 - 16

3. A Universal Framework for the Benefit-Risk Assessment of Medicines: Is This the Way Forward?

   • Stuart Walker
   • Neil McAuslane
   • Sam Salek

   Policy 30 December 2015 Pages: 17 - 25

4. An Assessment of Future Clinical Pharmacy Service Delivery in the Patient-Centered Medical Home

   • John Gettens
   • Timothy R. Hudd
   • Claire Santarelli

   Policy 30 December 2015 Pages: 26 - 32

5. Funding of Cancer Research: Do Levels Match Incidence and Mortality Rates?

   • Irwin G. Martin
   • Sowmya Mallela

   Policy 30 December 2015 Pages: 33 - 35

6. Development and Use of Reprints Tracking Reporter (RTR©) as a Medical Information Web-Based Tool for Compliance with the Physician Payments Sunshine Act

   • Robert J. Fuentes
   • Kazeem Idowu
   • Sanjay K. Sahoo

   Policy 30 December 2015 Pages: 36 - 44

7. A Survey of Key Opinion Leaders to Support Curriculum Development in Advanced Medical Science Liaison Training

   • Robert J. Moss
   • Emily B. Smith
   • Edward J. Weiner

   Policy 30 December 2015 Pages: 45 - 49

8. Clinical Development Approaches and Statistical Methodologies to Prospectively Assess the Cardiovascular Risk of New Antidiabetic Therapies for Type 2 Diabetes

   • Mary Jane Geiger
   • Cyrus Mehta
   • Brenda Gaydos

   Product Safety 30 December 2015 Pages: 50 - 64

9. Methods and Issues to Consider for Detection of Safety Signals From Spontaneous Reporting Databases: A Report of the DIA Bayesian Safety Signal Detection Working Group

   • A. Lawrence Gould
   • Theodore C. Lystig
   • Haijun Ma

   Product Safety 30 December 2015 Pages: 65 - 75

10. Reduction in Medication Errors: The Fentora Case Study

    • Gopal Reddy Palvatla
    • Irwin G. Martin

    Product Safety 30 December 2015 Pages: 76 - 80

11. Valacyclovir-Induced Acute Kidney Injury in Japanese Patients Based on the PMDA Adverse Drug Reactions Reporting Database

    • Asuka Kitano
    • Hideyuki Motohashi
    • Yoshitaka Yano

    Product Safety 30 December 2015 Pages: 81 - 85

12. Inferences Beyond a Study Design’s Grasp: A Cautionary Case Study From the Recent Renal Sympathetic Denervation Literature

    • J. Rick Turner
    • Eoin O’Brien

    Product Safety 30 December 2015 Pages: 86 - 92

13. Incorporating Historical Data in Bayesian Phase I Trial Design: The Caucasian-to-Asian Toxicity Tolerability Problem

    • Kentaro Takeda
    • Satoshi Morita

    Product Safety 30 December 2015 Pages: 93 - 99

14. Effective Drug Supply for Adaptive Clinical Trials: Recommendations by the DIA Adaptive Design Scientific Working Group Drug Supply Subteam

    • Nancy Burnham
    • Judith Quinlan
    • L. B. Wong

    Clinical Trials 30 December 2015 Pages: 100 - 107

15. Maximal Usage Trial: An Overview of the Design of Systemic Bioavailability Trial for Topical Dermatological Products

    • Edward Dennis Bashaw
    • Doanh C. Tran
    • Xiaomei Liu

    Clinical Trials 30 December 2015 Pages: 108 - 115

16. Smart Program Design Through a Common Information Model

    • Laszlo Vasko
    • Mats Sundgren
    • Martin Simán

    Clinical Trials 30 December 2015 Pages: 116 - 125

17. Multivariate Common Language Effect Size

    • Xiaofeng Steven Liu

    Clinical Trials 30 December 2015 Pages: 126 - 131

18. The Patient-Reported Outcome (PRO) Consortium: Lessons Learned Along the Path to PRO Instrument Qualification

    • Risa P. Hayes
    • Steven I. Blum
    • Stephen Joel Coons

    Clinical Trials 30 December 2015 Pages: 132 - 138

19. Management of Clinical Trial Agreements

    • JoAnn P. Pfeiffer
    • Frances J. Richmond

    Clinical Trials 30 December 2015 Pages: 139 - 145

20. Characterization of Missing Data in Clinical Registry Studies

    • Aaron B. Mendelsohn
    • Nancy A. Dreyer
    • Priscilla Velentgas

    Clinical Trials 30 December 2015 Pages: 146 - 154

21. Bayesian Design of Proof-of-Concept Trials

    • Roland Fisch
    • Ieuan Jones
    • Heinz Schmidli

    Biostatistics 30 December 2015 Pages: 155 - 162

22. Exact Bayesian Inference Comparing Binomial Proportions, With Application to Proof-of-Concept Clinical Trials

    • Oleksandr Sverdlov
    • Yevgen Ryeznik
    • Sheng Wu

    Biostatistics 30 December 2015 Pages: 163 - 174

23. How Should a Globalized CTD Be Created? An Introduction to the Japanese 3-Layer Approach

    • Katsumi Yoshida
    • Naoto Awaji
    • Osamu Komiyama

    Global Perspective 30 December 2015 Pages: 175 - 180

24. Analysis of the Current Situation of Antitumor Drug Use in China: A Hospital-Based Perspective

    • Yun-Feng Lai
    • Jin-Jian Lu
    • Yi-Tao Wang

    Global Perspective 30 December 2015 Pages: 181 - 193

25. Interprofessional Authorship in Critical Care Journals

    • Katie J. Suda
    • Amanda L. Torbett
    • Benjamin L. Zarzaur

    Product Development and Innovation 30 December 2015 Pages: 194 - 196

26. The Wider Use of Fixed-Dose Combinations Emphasizes the Need for a Global Approach to Regulatory Guideline Development

    • Yvonne Gautam
    • Ole J. Bjerrum
    • Merete Schmiegelow

    Regulatory Science 30 December 2015 Pages: 197 - 204