1.3(top 50%)
impact factor
1.2K(top 20%)
papers
7.0K(top 20%)
citations
31(top 20%)
h-index
1.3(top 50%)
impact factor
1.5K
all documents
8.1K
doc citations
46(top 20%)
g-index

Top Articles

#TitleJournalYearCitations
1Use of Medical Mobile Applications Among Hospital Pharmacists in MalaysiaTherapeutic Innovation and Regulatory Science2016234
2Partnering With Patients in the Development and Lifecycle of Medicines: A Call for ActionTherapeutic Innovation and Regulatory Science2015143
3Assessing the Financial Value of Patient Engagement: A Quantitative Approach from CTTI’s Patient Groups and Clinical Trials ProjectTherapeutic Innovation and Regulatory Science201896
4Minimizing Patient Burden Through the Use of Historical Subject-Level Data in Innovative Confirmatory Clinical Trials: Review of Methods and OpportunitiesTherapeutic Innovation and Regulatory Science201878
5Interpreting Change in Scores on Patient-Reported Outcome InstrumentsTherapeutic Innovation and Regulatory Science201671
6Improving Patient Involvement in Medicines Research and Development: A Practical RoadmapTherapeutic Innovation and Regulatory Science201769
7Advancing a Framework for Regulatory Use of Real-World Evidence: When Real Is ReliableTherapeutic Innovation and Regulatory Science201866
8Expanded Access of Investigational Drugs: The Experience of the Center of Drug Evaluation and Research Over a 10-Year PeriodTherapeutic Innovation and Regulatory Science201665
9New Governmental Regulatory System for Stem Cell—Based Therapies in JapanTherapeutic Innovation and Regulatory Science201464
10Overview of FDA’s Expanded Access Program for Investigational DrugsTherapeutic Innovation and Regulatory Science201760
11Legal, Regulatory, and Practical Issues to Consider When Adopting Decentralized Clinical Trials: Recommendations From the Clinical Trials Transformation InitiativeTherapeutic Innovation and Regulatory Science202057
12The Use of External Controls in FDA Regulatory Decision MakingTherapeutic Innovation and Regulatory Science202154
13Pediatric Medicine Development: An Overview and Comparison of Regulatory Processes in the European Union and United StatesTherapeutic Innovation and Regulatory Science201752
14Defining Patient-Centricity: Opportunities, Challenges, and Implications for Clinical Care and ResearchTherapeutic Innovation and Regulatory Science201347
15Adaptive Design: Results of 2012 Survey on Perception and UseTherapeutic Innovation and Regulatory Science201447
16Mobile Health Applications for Pediatric Care: Review and ComparisonTherapeutic Innovation and Regulatory Science201845
17A Review of Statistical Methods for Safety SurveillanceTherapeutic Innovation and Regulatory Science201444
18Aligning Estimators With Estimands in Clinical Trials: Putting the ICH E9(R1) Guidelines Into PracticeTherapeutic Innovation and Regulatory Science202043
19Bayesian Design of Proof-of-Concept TrialsTherapeutic Innovation and Regulatory Science201542
20Culture and Process Change as a Priority for Patient Engagement in Medicines DevelopmentTherapeutic Innovation and Regulatory Science201742
21Mobile Health Applications for Caring of Older People: Review and ComparisonTherapeutic Innovation and Regulatory Science201841
22Choosing Estimands in Clinical Trials: Putting the ICH E9(R1) Into PracticeTherapeutic Innovation and Regulatory Science202040
23Quality of FDM 3D Printed Medicines for Pediatrics: Considerations for Formulation Development, Filament Extrusion, Printing Process and Printer DesignTherapeutic Innovation and Regulatory Science202239
24Extrapolation of Efficacy in Pediatric Drug Development and Evidence-based Medicine: Progress and Lessons LearnedTherapeutic Innovation and Regulatory Science201838
25Improving Clinical Trial Participant Prescreening With Artificial Intelligence (AI): A Comparison of the Results of AI-Assisted vs Standard Methods in 3 Oncology TrialsTherapeutic Innovation and Regulatory Science202038
26Real World Evidence in Medical Cannabis ResearchTherapeutic Innovation and Regulatory Science202238
27Public- and Private-Sector Contributions to the Research and Development of the Most Transformational Drugs in the Past 25 Years: From Theory to TherapyTherapeutic Innovation and Regulatory Science201637
28The Impact of Protocol Amendments on Clinical Trial Performance and CostTherapeutic Innovation and Regulatory Science201637
29Choosing Appropriate Estimands in Clinical TrialsTherapeutic Innovation and Regulatory Science201535
30The Current Status of Sakigake Designation in Japan, PRIME in the European Union, and Breakthrough Therapy Designation in the United StatesTherapeutic Innovation and Regulatory Science201735
31The Rules of Engagement: CTTI Recommendations for Successful Collaborations Between Sponsors and Patient Groups Around Clinical TrialsTherapeutic Innovation and Regulatory Science201835
32Evaluating Source Data Verification as a Quality Control Measure in Clinical TrialsTherapeutic Innovation and Regulatory Science201433
33Mobile Medical Applications for Dosage Recommendation, Drug Adverse Reaction, and Drug Interaction: Review and ComparisonTherapeutic Innovation and Regulatory Science201733
34Recent Developments in the Prevention and Treatment of Missing DataTherapeutic Innovation and Regulatory Science201432
35Quantum of Effectiveness Evidence in FDA’s Approval of Orphan Drugs: Update, July 2010 to June 2014Therapeutic Innovation and Regulatory Science201532
36Patient Engagement at a Tipping Point—The Need for Cultural Change Across Patient, Sponsor, and Regulator Stakeholders: Insights From the DIA Conference, “Patient Engagement in Benefit Risk Assessment Throughout the Life Cycle of Medical Products”Therapeutic Innovation and Regulatory Science201632
37Patient Centricity and Pharmaceutical Companies: Is It Feasible?Therapeutic Innovation and Regulatory Science201731
38Value of Developing Plain Language Summaries of Scientific and Clinical Articles: A Survey of Patients and PhysiciansTherapeutic Innovation and Regulatory Science201831
39New Benchmarks Characterizing Growth in Protocol Design ComplexityTherapeutic Innovation and Regulatory Science201831
40Practical Considerations and Recommendations for Master Protocol Framework: Basket, Umbrella and Platform TrialsTherapeutic Innovation and Regulatory Science202131
41Measuring the Impact of Patient Engagement and Patient Centricity in Clinical Research and DevelopmentTherapeutic Innovation and Regulatory Science202030
42Attention-Deficit Hyperactivity Disorder and Pharmacotherapy—Past, Present, and Future: A Review of the Changing Landscape of Drug TherapyTherapeutic Innovation and Regulatory Science201528
43CBER’s Experience With Adaptive Design Clinical TrialsTherapeutic Innovation and Regulatory Science201628
44Neonatal Safety Information Reported to the FDA During Drug Development StudiesTherapeutic Innovation and Regulatory Science201827
45Utilizing Advanced Technologies to Augment Pharmacovigilance Systems: Challenges and OpportunitiesTherapeutic Innovation and Regulatory Science202027
46Evaluation of Blinded Independent Central Review of Tumor Progression in Oncology Clinical Trials: A Meta-analysisTherapeutic Innovation and Regulatory Science201326
47Patient Engagement by Pharma—Why and How? A Framework for Compliant Patient EngagementTherapeutic Innovation and Regulatory Science201526
48Ten-Year Experience for the Center for Drug Evaluation and Research, Part 2: FDA’s Role in Ensuring Patient SafetyTherapeutic Innovation and Regulatory Science201726
49Communicating Benefit and Risk Information in Direct-to-Consumer Print Advertisements: A Randomized StudyTherapeutic Innovation and Regulatory Science201525
50A Universal Framework for the Benefit-Risk Assessment of Medicines: Is This the Way Forward?Therapeutic Innovation and Regulatory Science201525