Proposed Proarrhythmic Cardiac Safety Education in Medical, Pharmacy, and Nursing Schools: An Interprofessional Model J. Rick Turner Editorials 30 December 2018 Pages: 529 - 530
From the Valley of Death to the Crossroads of Opportunity: A Discussion of Evolving Benefit/Risk Evaluation Standards Peter J. PittsPatrick Brady Editorials 30 December 2018 Pages: 531 - 536
The Near-Term Viability and Benefits of eLabels for Patients, Clinical Sites, and Sponsors Jodi Smith-GickNicola BarnesMichael Stephenson Sponsored Special Section by TransCelerate BioPharma: Original Research Open access 30 December 2018 Pages: 537 - 545
Minimizing Patient Burden Through the Use of Historical Subject-Level Data in Innovative Confirmatory Clinical Trials: Review of Methods and Opportunities Jessica LimRosalind WalleyEd Bowen Sponsored Special Section by TransCelerate BioPharma: Original Research Open access 30 December 2018 Pages: 546 - 559
Rethinking the Clinically Based Thresholds of TransCelerate BioPharma for Risk-Based Monitoring Richard C. ZinkAnastasia DmitrienkoAlex Dmitrienko Biostatistics: Original Research 30 December 2018 Pages: 560 - 571
Assessing Study Start-up Practices, Performance, and Perceptions Among Sponsors and Contract Research Organizations Mary Jo LambertiMichael WilkinsonKen Getz Clinical Trials: Original Research 30 December 2018 Pages: 572 - 578
Research Deviations in FDA-Regulated Clinical Trials: A Cross-Sectional Analysis of FDA Inspection Citations Craig A. GarmendiaKatrina EpnereNeera Bhansali Clinical Trials: Original Research 30 December 2018 Pages: 579 - 591
Research Misconduct in FDA-Regulated Clinical Trials: A Cross-sectional Analysis of Warning Letters and Disqualification Proceedings Craig A. GarmendiaNeera BhansaliPurnima Madhivanan Clinical Trials: Original Research 30 December 2018 Pages: 592 - 605
Clinical Trial Results Summary for Laypersons: A User Testing Study D. K. RaynorL. MyersA. Joos Clinical Trials: Original Research 30 December 2018 Pages: 606 - 628
Impact of Risk-Benefit Perception and Trust on Medical Technology Acceptance in Relation to Drug and Device Lag: A Tripartite Cross-Sectional Survey Koji TodakaJunji KishimotoHaruko Yamamoto Regulatory Science: Original Research 30 December 2018 Pages: 629 - 640
Juvenile Animal Testing: Assessing Need and Use in the Drug Product Label Paul Baldrick Regulatory Science: Original Research 30 December 2018 Pages: 641 - 648
Analysis of the Risks and Benefits of New Chemical Entities Approved by the US Food and Drug Administration (FDA) and Subsequently Withdrawn From the US Market Peter A. PatriarcaR. Michael Van AukenScott A. Kebschull Regulatory Science: Analytical Report 30 December 2018 Pages: 649 - 655
Quality of Medicine Information in Product Information Leaflets: A Retrospective Audit M. S. S. SaheehaM. H. S. PiumanthiG. H. Fernando Regulatory Science: Original Research 30 December 2018 Pages: 656 - 660
Patient Experience Data in US Food and Drug Administration (FDA) Regulatory Decision Making: A Policy Process Perspective Carrie M. Kuehn Regulatory Science: Original Research 30 December 2018 Pages: 661 - 668
Assessing the Benefit-Risk Profile for Pediatric Implantable Auditory Prostheses Laurel M. FisherAmy S. MartinezLaurie S. Eisenberg Special Populations: Original Research 30 December 2018 Pages: 669 - 679