Leveling the Joint Task Force Core Competencies for Clinical Research Professionals Stephen A. SonsteinRebecca J. Namenek BrouwerCarolynn Thomas Jones Original Article 06 January 2020 Pages: 1 - 20
Lessons Learned From Multi-regional Trials With Signals of Treatment Effect Heterogeneity Gang LiHui QuanPaul Gallo Review 06 January 2020 Pages: 21 - 31
Development of a Computer-Assisted Adverse Drug Events Alarm and Assessment System for Hospital Inpatients in China Chao ChenWangping JiaZhihui Tang Original Research 06 January 2020 Pages: 32 - 41
Adaptive Designs: Results of 2016 Survey on Perception and Use Alan HartfordMitchell ThomannCaroline Morgan Analytical Report 06 January 2020 Pages: 42 - 54
A Proposed Framework for a Globally Applicable Pragmatic Approach to Using Facilitated Regulatory Pathways Lawrence LibertiNeil McAuslaneHubert Leufkens Original Research 06 January 2020 Pages: 55 - 68
Improving Clinical Trial Participant Prescreening With Artificial Intelligence (AI): A Comparison of the Results of AI-Assisted vs Standard Methods in 3 Oncology Trials Denise Calaprice-WhittyKarim GalilBernal Jimenez Original Research 06 January 2020 Pages: 69 - 74
Survey of Customers Requesting Medical Information: Preferences and Information Needs of Patients and Health Care Professionals to Support Treatment Decisions Stacey M. FungCheryl SudMatthew Suchodolski Original Article 06 January 2020 Pages: 75 - 84
Standardization Consensus of a Hospital Drug Database: An Efficient Tool Mónica Gayoso-ReyElena Yaiza Romero-VentosaGuadalupe Piñeiro-Corrales Original Research 06 January 2020 Pages: 85 - 92
Differences in Clinical Research Perceptions and Experiences by Age Subgroup Annick AndersonDeborah BorfitzKenneth Getz Original Research 06 January 2020 Pages: 93 - 102
Measuring the Impact of Patient Engagement and Patient Centricity in Clinical Research and Development Stella StergiopoulosDebra L. MichaelsKenneth A. Getz Original Research 06 January 2020 Pages: 103 - 116
The Power Derivative Principle, and Its Application to How and When to Perform a One-Shot Unblinded Reassessment Sample Size Elodie BlondiauxEric Derobert Original Research (Statistics) 06 January 2020 Pages: 117 - 127
Review of Drugs Approved via the 505(b)(2) Pathway: Uncovering Drug Development Trends and Regulatory Requirements Ingrid FreijeStéphane LamoucheMario Tanguay OriginalPaper Open access 06 January 2020 Pages: 128 - 138
Risk-Based Monitoring Approach to Ensure the Quality of Clinical Study Data and Enable Effective Monitoring Ayano HigaMichie YagiHiraku Akiho Original Research 06 January 2020 Pages: 139 - 143
Updating the Clinical Picture of Facioscapulohumeral Muscular Dystrophy: Ramifications for Drug Development With Potential Solutions Raymond A. HumlOlga Uspenskaya-CadozZachary Slifer Analytical Report 06 January 2020 Pages: 144 - 150
Determinants of Generic Drug Substitution in the United States Jodi B. SegalOluwadamilola OnasanyaRobert J. Romanelli Original Article 06 January 2020 Pages: 151 - 157
Assessing Outsourcing Oversight Practices and Performance Michael WilkinsonBeth HarperKen Getz Original Research 06 January 2020 Pages: 158 - 166
A Practical Perspective: Application of the Generalized Approach for Adaptive Design Jin WangJuanjuan LiXiaolu Su Original Research 06 January 2020 Pages: 167 - 170
An Overview of the Drug Registration Requirements for Export to Tanzania, Nepal, and Cambodia Triveni V. ShelkeShyam KhanteVinod L. Gaikwad Review Article 06 January 2020 Pages: 171 - 176
Regulatory Issues of Voluntary Certification of Food Supplements in Russia Raimond Lozda Review Article 06 January 2020 Pages: 177 - 183
Efficient Design of Integrated and Adaptively Interlinked Protocols for Early-Phase Drug Development Programs Simon CoatesOliver PohlUlrike Lorch Analytical Report 06 January 2020 Pages: 184 - 194
How Do Drug Regulatory Bodies Deal With Potential Innovative Therapies? Michaela TutoneFederico VillaGiovanni Tafuri Review 06 January 2020 Pages: 195 - 199
Investigation of Approval Trends and Benefits of New Fixed-Dose Combination Drugs in Japan Chikara KikuchiMifuyu OhnoTakao Aoyama Original Article 06 January 2020 Pages: 200 - 210
Statistical Methods for Clinical Study Site Selection Jianjin XuLan HuangRam Tiwari Original Research 06 January 2020 Pages: 211 - 219
Sentiment of Media Coverage and Reputation of the Pharmaceutical Industry Valentina PampulevskiJessica R. GiaquintoJuan C. Nadal Original Research 06 January 2020 Pages: 220 - 225
Tenders for the Procurement of Medical Devices: Adapting Cost-Effectiveness Rules to the Requirements of the European Public Procurement Directive Andrea MessoriSabrina TrippoliClaudio Marinai OriginalPaper 06 January 2020 Pages: 226 - 231
Reasons for Premature Conclusion of Late Phase Clinical Trials: An Analysis of ClinicalTrials.gov Registered Phase III Trials Daphne GuinnErin E. WilhelmIra Shoulson Original Research Manuscript 06 January 2020 Pages: 232 - 239
Investigation of the Influencing Factors on the Incidence of Vertebral Fracture: A Meta-analysis Based on Placebo Data of Randomized Clinical Trials Tsuyoshi KobayashiMasayuki KanekoMamoru Narukawa Original Research 06 January 2020 Pages: 240 - 245
Adaptive Design: A Review of the Technical, Statistical, and Regulatory Aspects of Implementation in a Clinical Trial Franck Pires CerqueiraAngelo Miguel Cardoso JesusMaria Dulce Cotrim Review Articles 06 January 2020 Pages: 246 - 258