The Role of Worst-Case Scenarios in Sponsors’ and Regulators’ Decision Making J. Rick Turner Editorial 31 December 2019 Pages: 5 - 7
Accelerating Adoption of Patient-Facing Technologies in Clinical Trials: A Pharmaceutical Industry Perspective on Opportunities and Challenges Ashley M. PolhemusHassan KadhimMelissa Dupont TransCelerate Special Section: Original Article Open access 31 December 2019 Pages: 8 - 24
Process Management Framework: Guidance to Successful Implementation of Processes in Clinical Development Michael Edward HusovichRuzica ZadroBeata Rygiel-Zbikowska TransCelerate Special Section: Original Article Open access 31 December 2019 Pages: 25 - 35
Quality Risk Management Framework: Guidance for Successful Implementation of Risk Management in Clinical Development Melissa SuprinAllan ChowIrene Tomlin TransCelerate Special Section: Original Article Open access 31 December 2019 Pages: 36 - 44
Investigation of the Study Characteristics Affecting Clinical Trial Quality Using the Protocol Deviations Leading to Exclusion of Subjects From the Per Protocol Set Data in Studies for New Drug Application: A Retrospective Analysis Norihito KoharaMasayuki KanekoMamoru Narukawa Clinical Trials: Original Article 31 December 2019 Pages: 45 - 51
Use of Proxy Variables to Determine the Impact of Protocol Complexity on Clinical Research Site Productivity David J. Morin Clinical Trials: Original Article 31 December 2019 Pages: 52 - 58
Unresectable and Metastatic Melanoma of the Skin: Literature Review of Clinical Trials and Efficacy Endpoints Since 2000 Susan JinPallavi S. Mishra-KalyaniRajeshwari Sridhara Clinical Trials: Review 31 December 2019 Pages: 59 - 70
Baseline Assessment of the Evolving 2017 eClinical Landscape Michael WilkinsonRichard YoungKen Getz Clinical Trials: Original Article 31 December 2019 Pages: 71 - 80
Common Filing Deficiencies in Abbreviated New Drug Applications Containing Clinical Endpoint Studies Lewis J. FermaglichRu ChenYing Fan Clinical Trials: Original Article 31 December 2019 Pages: 81 - 85
A Comparative Review of Marketing Authorization Decisions in Switzerland, the EU, and the USA Simon Dalla Torre Di SanguinettoEsa HeinonenClaus Bolte Global Perspectives: Original Article 31 December 2019 Pages: 86 - 94
Youth Experience With Community Pharmacy Services and Their Perceptions Toward Implementation of Medication Therapy Management Services by Community Pharmacists in the Western Region of Saudi Arabia Mahmoud S. Alhaddad Global Perspectives: Original Article 31 December 2019 Pages: 95 - 99
Comparison of Brief Summary Formats Through a Health Literacy Lens Michele L. SharpLori HallLinda Neuhauser Medical Communications: Original Article 31 December 2019 Pages: 100 - 109
Risk of Cleft Lip and/or Palate Associated With Antiepileptic Drugs: Postmarketing Safety Signal Detection and Evaluation of Information Presented to Prescribers and Patients Bita RezaallahDavid John LewisBritt-Isabelle Berg Product Safety: Original Article 31 December 2019 Pages: 110 - 119
Biomaterials Evaluation: Conceptual Refinements and Practical Reforms Reza MasaeliKavosh ZandsalimiLobat Tayebi Product Safety: Review 31 December 2019 Pages: 120 - 127
Reported Adverse Drug Reactions During the Use of Corticosteroids in a Tertiary Care Hospital Sarika Paradkar Product Safety: Original Article 31 December 2019 Pages: 128 - 131
Use of Proprietary Names by Prescribers When Prescribing Over-the-Counter (OTC) Drug Products Chi-Ming Tu Regulatory Science: Original Article 31 December 2019 Pages: 132 - 137
Influence of Drug Lag on New Drug Label Revisions Chikara KikuchiMiyako MurakamiTakao Aoyama Regulatory Science: Original Article 31 December 2019 Pages: 138 - 145
Developing and Implementing Performance Outcome Assessments: Evidentiary, Methodologic, and Operational Considerations Elizabeth RichardsonJessica BurnellGregory Daniel Regulatory Science: Original Article 31 December 2019 Pages: 146 - 153
Unique Burdens of Pediatric Clinical Trials in Duchenne Muscular Dystrophy, April 20–21, 2017, Bethesda, Maryland, USA Timothy FransonKathi KinnettTimothy P. Cripe Special Populations: Meeting Report 31 December 2019 Pages: 154 - 163
