A Novel Collaborative Approach to Building Better Clinical Trials: New Insights From a Patient Engagement Workshop to Propel Patient-Centricity Forward Alyson GreggNova GetzAnnick Anderson Original Research 04 January 2020 Pages: 485 - 491
Pediatric Antibiotic Pack Size Compliance With the Dosage Regimen: A Descriptive Study Iram MalikMuhammad AtifNafees Ahmad OriginalPaper 06 January 2020 Pages: 492 - 506
A Systematic Approach for Post Hoc Subgroup Analyses With Applications in Clinical Case Studies Christoph MuysersAlex DmitrienkoStephanie Roll Biostatistics: Original Research 06 January 2020 Pages: 507 - 518
Innovation in Clinical Trial Design and Product Promotion: Evolving the Patient Perspective With Regulatory and Technological Advances Mary L. Raber-JohnsonWolfgang E. GallwitzPhilip Storer Review 06 January 2020 Pages: 519 - 527
Challenges on Multiple Endpoints in Clinical Trials: An Industry Survey in Japan Kentaro SakamakiSeitaro YoshidaSatoru Fukimbara Original Article 06 January 2020 Pages: 528 - 533
Development and Validation of a Brief Measure of Self-Management Competence: The Self-Management Self-Test (SMST) Peter M. WehmeierTheresa FoxUrs M. Nater OriginalPaper 06 January 2020 Pages: 534 - 543
Analyzing Upward Deviation of Actual vs Predicted Drug Sales in Japan for a Reasonable Drug-Pricing Policy Shoyo ShibataDaigo FukumotoKoken Ozaki Original Research 06 January 2020 Pages: 544 - 551
Global Pediatric Regulations: An Overview Priya M. GadgePrathmesh P. KenjaleVinod L. Gaikwad Review 06 January 2020 Pages: 552 - 558
A Comparison Between a Meta-analytic Approach and Power Prior Approach to Using Historical Control Information in Clinical Trials With Binary Endpoints Naoki IsogawaKentaro TakedaTakashi Daimon Original Article 06 January 2020 Pages: 559 - 570
Combined-Indications Significance Level of Multiple Related Indications Developed Simultaneously Jiacheng YuanRay ZhuGary Koch Original Article 06 January 2020 Pages: 571 - 576
How and Why to Involve Patients in Drug Development: Perspectives From the Pharmaceutical Industry, Regulatory Authorities, and Patient Organizations Marianne Botoft HansenLotte Stig NørgaardChristine Erikstrup Hallgreen Original Research 06 January 2020 Pages: 577 - 585
Nonclinical Immunotoxicity Testing in the Pharmaceutical World: The Past, Present, and Future Paul Baldrick Original Article 06 January 2020 Pages: 586 - 597
Assessing Patient Participation Burden Based on Protocol Design Characteristics Kenneth GetzVenkat SethuramanStella Stergiopoulos Original Research 06 January 2020 Pages: 598 - 604
Patient Feedback on a Warfarin Action Plan Used in a Local Australian Physician Practice Setting Angela W.P. YiuVincent W. LeeBeata V. Bajorek Original Research 06 January 2020 Pages: 605 - 612
The Medical Device Regulation of the European Union Intensifies Focus on Clinical Benefits of Devices Beata WilkinsonRobert van Boxtel Review Article 06 January 2020 Pages: 613 - 617
Development of Performance Indicators for Clinical Research Coordinators Using the Balanced Scorecard in South Korea Youn Sun HwangTae Wha Lee Original Research 06 January 2020 Pages: 618 - 625
Is There a Difference Between the Readabilities of Informed Consent Forms Used for Elective and Emergency Procedures in Turkey? Mehmet Giray SönmezLeyla Öztürk SönmezZerrin Defne Dündar Original Research 06 January 2020 Pages: 626 - 630
Preparation of Direct Healthcare Professional Communication: An Exploratory Study on the Experiences and Perceptions of European Pharmaceutical Companies and the EMA Arnela BoskovicMathias MøllebækSusanne Kaae Original Research 06 January 2020 Pages: 631 - 639
Impact of FDA-Required Cardiovascular Outcome Trials on Type 2 Diabetes Clinical Study Initiation From 2008 to 2017 Cameron M. KiefferAndrew S. Robertson Original Research Open access 06 January 2020 Pages: 640 - 644
Pharmaceutical Benefit-Risk Perception and Older Age: A Pilot Study Dominic Hugo Patrick Balog-WayRagnar Ernst Löfstedt Original Research 06 January 2020 Pages: 645 - 657
Breakthrough Therapy, PRIME and Sakigake: A Comparison Between Neuroscience and Oncology in Obtaining Preferred Regulatory Status Elena Tomaselli MuenstermanYijia LuoJonathon M Parker Original Research 06 January 2020 Pages: 658 - 666
Postmarketing Safety of Biosimilars: Current Status, Challenges, and Opportunities in the Spontaneous Reporting System Abhishek SinghMuthusamy KalaivaniSuresh K. Gupta Review Article 06 January 2020 Pages: 667 - 680
Sequentially Determined Measures of Interobserver Agreement (Kappa) in Clinical Trials May Vary Independent of Changes in Observer Performance Russell ReeveKlaus Gottlieb Original Research (Statistics) 06 January 2020 Pages: 681 - 686
Single-Study Approvals: Quantum of Evidence Required Frank J. SasinowskiMichelle L. Butler Analytical Report Open access 06 January 2020 Pages: 687 - 692
In Vitro Skin Permeation Methodology for Over-The-Counter Topical Dermatologic Products Luke OhSojeong YiEdward Bashaw Review Article 06 January 2020 Pages: 693 - 700
Public Attitudes Toward the Secondary Uses of Patient Records for Pharmaceutical Companies’ Activities in Japan Haruka NakadaYusuke InoueShimon Tashiro Original Research 06 January 2020 Pages: 701 - 708
FDA Reported Use of Patient Experience Data in 2018 Drug Approvals Cameron M. KiefferAlexis Reisin MillerAndrew S. Robertson Original Research Open access 06 January 2020 Pages: 709 - 716
Improving the Standards of Reporting of Clinical Trial Data Jitendra Ganju Commentary 06 January 2020 Pages: 717 - 722