Risk of Extrapyramidal Syndromes Associated With Psychotropic Polypharmacy: A Study Based on Large-Scale Japanese Claims Data Yoko Hirano Original Research 13 January 2020 Pages: 259 - 268
A Study Design for Augmenting the Control Group in a Randomized Controlled Trial: A Quality Process for Interaction Among Stakeholders Yunling XuNelson LuRam Tiwari Commentary 06 January 2020 Pages: 269 - 274
Quality Decision Making in Health Technology Assessment: Issues Facing Companies and Agencies Magdalena BujarNeil McAuslaneSam Salek Original Research 08 January 2020 Pages: 275 - 282
Building a Better Approach for the Benefit of Patients: 10 Pillars to Strengthen Regulatory Review Systems Globally Julie O’BrienRebecca Sarah LumsdenJudith Catherine Macdonald Expert Commentary Open access 06 January 2020 Pages: 283 - 292
MI-ND Medical Information–News Delivery: Providing Health Care Professionals With Medical Information “Proactively” by Using MessengerPeople Jürgen LautnerSimone Maaß-KoedelMarie-Luise Helmich Original Research 06 January 2020 Pages: 293 - 296
Analysis of the Authorized Target Populations for Fixed Dose Combination Products Between 2000 and 2017 Reveals Discrepancies Between EMA’s and FDA’s Views on Initial Dual-Therapy Ole Jannik BjerrumSascha EichendorffNada Bassam Alkis Original Research 06 January 2020 Pages: 297 - 302
Assessing Real-World Data Quality: The Application of Patient Registry Quality Criteria to Real-World Data and Real-World Evidence Richard E. GliklichMichelle B. Leavy Expert Commentary 06 January 2020 Pages: 303 - 307
Peptide Phage Display: Molecular Principles and Biomedical Applications Marlon S. Zambrano-MilaKaren Elizabeth Sánchez BlacioNelson Santiago Vispo ReviewPaper 06 January 2020 Pages: 308 - 317
Evaluating REMS Burden: A Comparative Time Analysis of 3 Channels for REMS Stakeholders to Perform Mandatory REMS Tasks Jennifer ChapmanJohn FreemanPaul Sheehan Original Research 06 January 2020 Pages: 318 - 323
Choosing Estimands in Clinical Trials: Putting the ICH E9(R1) Into Practice Bohdana RatitchJames BellIlya Lipkovich Analytical Report 04 January 2020 Pages: 324 - 341
Barriers for Pharmaceutical Innovation With Focus in Cancer Drugs, the Case of Mexico Alfonso Duenas-GonzalezAurora Gonzalez-Fierro Review 06 January 2020 Pages: 342 - 352
Aligning Estimators With Estimands in Clinical Trials: Putting the ICH E9(R1) Guidelines Into Practice C. H. MallinckrodtJ. BellG. Molenberghs Analytical Report 06 January 2020 Pages: 353 - 364
Probiotics and Their Quality-Related Concerns: Highlights From the Saudi Arabian Market Fahad S. AldawsariBandar S. Bin HelelMubark Al Abudahash Original Research Article 06 January 2020 Pages: 365 - 369
Defining Efficacy Estimands in Clinical Trials: Examples Illustrating ICH E9(R1) Guidelines Bohdana RatitchNiti GoelMichael O’Kelly Analytical Report 06 January 2020 Pages: 370 - 384
Evaluating Literature for Oncology Data Gaps to Improve the Quality of Standard Response Letters: A Retrospective Review Shanada Monestime Original Article 06 January 2020 Pages: 385 - 389
Open Payments and the US Clinical Landscape Harold E. Glass Original Article 06 January 2020 Pages: 390 - 395
Disease Modification in Alzheimer’s Disease: Current Thinking Hong Liu-SeifertJennifer SchumiRichard Entsuah ReviewPaper 06 January 2020 Pages: 396 - 403
US Physician and Nurse Proclivity to Refer Their Patients Into Clinical Trials Kenneth A. Getz Original Research Manuscript 06 January 2020 Pages: 404 - 410
Exact Unconditional Tests for Dichotomous Data When Comparing Multiple Treatments With a Single Control Guogen ShanCarolee Dodge-FrancisGregory E. Wilding Original Article 06 January 2020 Pages: 411 - 417
Notable Differences in Drug Lag Between Korea and Japan of New Drugs Between 2009 and 2017 Sang-Won LeeSo-Hee ParkJu-Young Shin Original Research 06 January 2020 Pages: 418 - 423
Estimating the Impact of Food and Drug Administration’s Unapproved Drug Initiative on Drug Prices and Sales Dolly SharmaGlen T. SchumockSurrey M. Walton OriginalPaper 06 January 2020 Pages: 424 - 430
Masking in Pragmatic Trials: Who, What, and When to Blind Jennifer B. ChristianEmily S. BrouwerNancy A. Dreyer Commentary Open access 08 January 2020 Pages: 431 - 436
Exact Confidence Limits on Some New Measures of Concordance and Discordance in Binary Outcomes Kung-Jong Lui Original Research 06 January 2020 Pages: 437 - 443
A Time of Optimism: Targeted Immunotherapeutics as the Long-Awaited Armamentaria Against the Scourge of Human Diseases Charles OoRobert J. Noveck Letter to Editor 06 January 2020 Pages: 444 - 446
Global Regulatory Landscape for Aggregate Safety Assessments: Recent Developments and Future Directions Greg BallRaffael KurekLothar Tremmel Original Research 06 January 2020 Pages: 447 - 461
Shared Learnings on the New EMA First-in-Human and Early Clinical Trial Guideline: Proceedings From a DIAlogue Session at DIA Europe 2018 Jan Willem van der LaanCharles T. BensonSalah-Dine Chibout Session Proceedings 06 January 2020 Pages: 462 - 467
Evaluation of Legal Legislation Compliance and Readability of Clinical Trial Informed Consent Forms Buket GungorMualla AylinAyse Gelal Original Research 08 January 2020 Pages: 468 - 475
Evaluating the Understandability and Actionability of Web-Based Education Materials for Patients Taking Non–vitamin K Oral Anticoagulants Angela YiuKingsley K. NgBeata V. Bajorek OriginalPaper 06 January 2020 Pages: 476 - 483