Treatment of Death Events in the Analysis of Time to Progression Tetsuo SaitoKenta Murotani Letter to the Editor 05 October 2021 Pages: 1 - 3
Heart Failure Population with Therapeutic Response to Sacubitril/Valsartan, Spironolactone and Candesartan: FDA Perspective Charu GandotraJennifer ClarkNorman L. Stockbridge Commentary 26 October 2021 Pages: 4 - 7
Real World Evidence in Medical Cannabis Research Rishi BanerjeeSimon ErridgeMikael Hans Sodergren Commentary Open access 08 November 2021 Pages: 8 - 14
A Framework for Extension Studies Using Real-World Data to Examine Long-Term Safety and Effectiveness Mehmet BurcuCyntia B. Manzano-SalgadoJennifer B. Christian Review Open access 12 July 2021 Pages: 15 - 22
Adverse Events in the Digital Age: Finding the Sharpest Tool in the Box Robert Di GiovanniAndrew CochraneDavid J. Lewis Review 07 September 2021 Pages: 23 - 37
U.S. Food and Drug Administration’s Patient-Focused Drug Development Initiative: Experience with Integration of Patient-Experience Data in a New Drug Application for Esketamine Nasal Spray Plus a Newly Initiated Oral Antidepressant for Treatment-Resistant Depression Eva G. KatzPauline McNultyCarol Jamieson Analytical Report Open access 08 October 2021 Pages: 38 - 46
Laboratory-Developed Tests: Design of a Regulatory Strategy in Compliance with the International State-of-the-Art and the Regulation (EU) 2017/746 (EU IVDR [In Vitro Diagnostic Medical Device Regulation]) Folker SpitzenbergerJaimin PatelChristian Meisel Original Research Open access 21 July 2021 Pages: 47 - 64
Data-Driven Subgroup Identification in Confirmatory Clinical Trials Pierre BunoufMélanie GrocIlya Lipkovich Original Research 29 July 2021 Pages: 65 - 75
Healthy Volunteer Studies in the Development of Anticancer Drugs with Genotoxic Findings Grace Omes-SmitMarjolein GarsenAlex Zwiers Original Research Open access 11 August 2021 Pages: 76 - 84
Co-Development of Oncology Drugs and Companion Diagnostics: Analyses of Approval Lags and Drug Development Periods in Recently Approved Cases in Japan Akari TanakaHirofumi SuzukiNaomi Nagai Original Research 18 August 2021 Pages: 85 - 95
The Medical Science Liaison Role in Spain: A Survey About the Opinion of HealthCare Professionals Antonio González del CastilloCristina GarcíaVictor Sastre Original Research 20 August 2021 Pages: 96 - 103
RETRACTED ARTICLE: Seasonal and Secular Periodicities Identified in the Dynamics of US FDA Medical Devices (1976–2020): Portends Intrinsic Industrial Transformation and Independence of Certain Crises Iraj Daizadeh Original Research 23 August 2021 Pages: 104 - 116
Exploring How and Why to Develop Patient-Centered Packaging: A Multiple-Case Study with Pharmaceutical Companies Giana Carli LorenziniAnnika Olsson Original Research Open access 28 September 2021 Pages: 117 - 129
Detection of Fraud in a Clinical Trial Using Unsupervised Statistical Monitoring Sylviane de VironLaura TrottaMarc Buyse Original Research Open access 29 September 2021 Pages: 130 - 136
A Novel Case Study of the Use of Real-World Evidence to Support the Registration of an Osteoporosis Product in China Neal E. StormWen ChangSteven K. Galson Original Research Open access 11 October 2021 Pages: 137 - 144
Mixed Models for Repeated Measures Should Include Time-by-Covariate Interactions to Assure Power Gains and Robustness Against Dropout Bias Relative to Complete-Case ANCOVA Alejandro Schuler Original Research 21 October 2021 Pages: 145 - 154
A Comprehensive Nomogram Combining CT Imaging with Clinical Features for Prediction of Lymph Node Metastasis in Stage I–IIIB Non-small Cell Lung Cancer Xingxing ZhengJingjing ShaoFeng Feng Original Research 26 October 2021 Pages: 155 - 167
Increased Patient’s Risk Associated with the Canadian Bioequivalence Guidance Due to Outlier Removal Anders Fuglsang Original Research 30 October 2021 Pages: 168 - 172
