1. A Milestone: Therapeutic Innovation & Regulatory Science Has Been Accepted for Inclusion in MEDLINE

   • J. Rick Turner

   Editorial 30 December 2018 Pages: 265 - 266

2. Keeping a Focus on Research Ethics

   • Lindsay McNair

   Special Section — Research Ethics: Editorial 30 December 2018 Pages: 267 - 267

3. Truth in Advertising: Disclosure of Participant Payment in Research Recruitment Materials

   • Luke Gelinas
   • Holly Fernandez Lynch
   • Barbara E. Bierer

   Special Section — Research Ethics 30 December 2018 Pages: 268 - 274

4. Adults Lacking Capacity to Give Consent: When Is It Acceptable to Include Them in Research?

   • David G. Forster
   • David A. Borasky Jr

   Special Section — Research Ethics Open access 30 December 2018 Pages: 275 - 279

5. Ethical Issues in Research Involving Participants With Opioid Use Disorder

   • Emily Anderson
   • Lindsay McNair

   Special Section — Research Ethics Open access 30 December 2018 Pages: 280 - 284

6. Improving Expanded Access in the United States: The Role of the Institutional Review Board

   • Kelly McBride Folkers
   • Alison Bateman-House

   Special Section — Research Ethics 30 December 2018 Pages: 285 - 293

7. An Alternative to Disproportionality: A Frequency-Based Method for Pharmacovigilance Data Mining

   • Jeremy D. Jokinen
   • Fabio Lievano
   • Melissa Truffa

   Biostatistics: Original Research 30 December 2018 Pages: 294 - 299

8. Sample Size for Biosimilar Trials: In Defense of Synthesis

   • Timothy Clark
   • Sook Jung Jo
   • Alan Phillips

   Biostatistics: Analytical Report 30 December 2018 Pages: 300 - 305

9. Longitudinal Modeling Approaches to Assess the Association Between Changes in 2 Clinical Outcome Assessments

   • Dawn Odom
   • Lori McLeod
   • David McSorley

   Biostatistics: Original Research 30 December 2018 Pages: 306 - 312

10. A Resource-Based Relative Value for Clinical Research Nurses’ Workload

    • Sangmi Lee
    • Ihn Sook Jeong

    Clinical Trials: Original Research 30 December 2018 Pages: 313 - 320

11. The Early Preclinical Development Program for Locally Administered Investigational Medicinal Products in Ophthalmology: Preclinical Data Required for Starting a First-in-Human Clinical Trial in Europe—Basic Considerations and 2 Case Studies

    • Annick Toggenburger
    • Rebecca Trönnberg
    • Georg A. Mathis

    Global Perspectives: Original Research 30 December 2018 Pages: 321 - 328

12. Statistical Signal Process in R Language in the Pharmacovigilance Programme of India

    • Aman Kumar
    • Jitin Ahuja
    • Vivekanandan Kalaiselvan

    Global Perspectives: Original Research 30 December 2018 Pages: 329 - 333

13. Utility of Bayesian Single-Arm Design in New Drug Application for Rare Cancers in Japan: A Case Study of Phase 2 Trial for Sarcoma

    • Akihiro Hirakawa
    • Tadaaki Nishikawa
    • Yasuhiro Fujiwara

    Global Perspectives: Original Research 30 December 2018 Pages: 334 - 338

14. Comparison of Serious Adverse Event Profiles Among Antirheumatic Agents Using Japanese Adverse Drug Event Report Database

    • Yomei Matsuoka
    • Mamoru Narukawa

    Global Perspectives: Original Research 30 December 2018 Pages: 339 - 347

15. Evaluation and Characterization of Health Economics and Outcomes Research in SAARC Nations

    • Manthan Mehta
    • Rajan Nerurkar

    Global Perspectives: Original Research 30 December 2018 Pages: 348 - 353

16. Safety Reporting: It Can Enter the 21st Century—If We Let It

    • Jonathan Seltzer
    • Amit Bhattacharyya

    Product Safety: Commentary 30 December 2018 Pages: 354 - 361

17. Advancing a Framework for Regulatory Use of Real-World Evidence: When Real Is Reliable

    • Nancy A. Dreyer

    Regulatory Science: Commentary Open access 30 December 2018 Pages: 362 - 368

18. FDA Expectations for Demonstrating Interchangeability

    • Kamali Chance

    Regulatory Science: Review 30 December 2018 Pages: 369 - 373

19. Mobile Health Applications for Caring of Older People: Review and Comparison

    • Victoria Laput Anthony Berauk
    • Muthu Kumar Murugiah
    • Long Chiau Ming

    Special Populations: Original Research 30 December 2018 Pages: 374 - 382

20. Mobile Health Applications for Pediatric Care: Review and Comparison

    • Samantha Sangie Morse
    • Muthu Kumar Murugiah
    • Long Chiau Ming

    Special Populations: Original Research 30 December 2018 Pages: 383 - 391

21. Erratum to: Implications of CRISPR-based germline engineering for cancer survivors

    • Gregory Katz
    • Peter J. Pitts

    Erratum 30 December 2018 Pages: 392 - 392