# | Title | Journal | Year | Citations |
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1 | Use of Medical Mobile Applications Among Hospital Pharmacists in Malaysia | Therapeutic Innovation and Regulatory Science | 2016 | 234 |
2 | Partnering With Patients in the Development and Lifecycle of Medicines: A Call for Action | Therapeutic Innovation and Regulatory Science | 2015 | 143 |
3 | Assessing the Financial Value of Patient Engagement: A Quantitative Approach from CTTI’s Patient Groups and Clinical Trials Project | Therapeutic Innovation and Regulatory Science | 2018 | 96 |
4 | Minimizing Patient Burden Through the Use of Historical Subject-Level Data in Innovative Confirmatory Clinical Trials: Review of Methods and Opportunities | Therapeutic Innovation and Regulatory Science | 2018 | 78 |
5 | Interpreting Change in Scores on Patient-Reported Outcome Instruments | Therapeutic Innovation and Regulatory Science | 2016 | 71 |
6 | Improving Patient Involvement in Medicines Research and Development: A Practical Roadmap | Therapeutic Innovation and Regulatory Science | 2017 | 69 |
7 | Advancing a Framework for Regulatory Use of Real-World Evidence: When Real Is Reliable | Therapeutic Innovation and Regulatory Science | 2018 | 66 |
8 | Expanded Access of Investigational Drugs: The Experience of the Center of Drug Evaluation and Research Over a 10-Year Period | Therapeutic Innovation and Regulatory Science | 2016 | 65 |
9 | New Governmental Regulatory System for Stem Cell—Based Therapies in Japan | Therapeutic Innovation and Regulatory Science | 2014 | 64 |
10 | Overview of FDA’s Expanded Access Program for Investigational Drugs | Therapeutic Innovation and Regulatory Science | 2017 | 60 |
11 | Legal, Regulatory, and Practical Issues to Consider When Adopting Decentralized Clinical Trials: Recommendations From the Clinical Trials Transformation Initiative | Therapeutic Innovation and Regulatory Science | 2020 | 57 |
12 | The Use of External Controls in FDA Regulatory Decision Making | Therapeutic Innovation and Regulatory Science | 2021 | 54 |
13 | Pediatric Medicine Development: An Overview and Comparison of Regulatory Processes in the European Union and United States | Therapeutic Innovation and Regulatory Science | 2017 | 52 |
14 | Defining Patient-Centricity: Opportunities, Challenges, and Implications for Clinical Care and Research | Therapeutic Innovation and Regulatory Science | 2013 | 47 |
15 | Adaptive Design: Results of 2012 Survey on Perception and Use | Therapeutic Innovation and Regulatory Science | 2014 | 47 |
16 | Mobile Health Applications for Pediatric Care: Review and Comparison | Therapeutic Innovation and Regulatory Science | 2018 | 45 |
17 | A Review of Statistical Methods for Safety Surveillance | Therapeutic Innovation and Regulatory Science | 2014 | 44 |
18 | Aligning Estimators With Estimands in Clinical Trials: Putting the ICH E9(R1) Guidelines Into Practice | Therapeutic Innovation and Regulatory Science | 2020 | 43 |
19 | Bayesian Design of Proof-of-Concept Trials | Therapeutic Innovation and Regulatory Science | 2015 | 42 |
20 | Culture and Process Change as a Priority for Patient Engagement in Medicines Development | Therapeutic Innovation and Regulatory Science | 2017 | 42 |
21 | Mobile Health Applications for Caring of Older People: Review and Comparison | Therapeutic Innovation and Regulatory Science | 2018 | 41 |
22 | Choosing Estimands in Clinical Trials: Putting the ICH E9(R1) Into Practice | Therapeutic Innovation and Regulatory Science | 2020 | 40 |
23 | Quality of FDM 3D Printed Medicines for Pediatrics: Considerations for Formulation Development, Filament Extrusion, Printing Process and Printer Design | Therapeutic Innovation and Regulatory Science | 2022 | 39 |
24 | Extrapolation of Efficacy in Pediatric Drug Development and Evidence-based Medicine: Progress and Lessons Learned | Therapeutic Innovation and Regulatory Science | 2018 | 38 |
25 | Improving Clinical Trial Participant Prescreening With Artificial Intelligence (AI): A Comparison of the Results of AI-Assisted vs Standard Methods in 3 Oncology Trials | Therapeutic Innovation and Regulatory Science | 2020 | 38 |
26 | Real World Evidence in Medical Cannabis Research | Therapeutic Innovation and Regulatory Science | 2022 | 38 |
27 | Public- and Private-Sector Contributions to the Research and Development of the Most Transformational Drugs in the Past 25 Years: From Theory to Therapy | Therapeutic Innovation and Regulatory Science | 2016 | 37 |
28 | The Impact of Protocol Amendments on Clinical Trial Performance and Cost | Therapeutic Innovation and Regulatory Science | 2016 | 37 |
29 | Choosing Appropriate Estimands in Clinical Trials | Therapeutic Innovation and Regulatory Science | 2015 | 35 |
30 | The Current Status of Sakigake Designation in Japan, PRIME in the European Union, and Breakthrough Therapy Designation in the United States | Therapeutic Innovation and Regulatory Science | 2017 | 35 |
31 | The Rules of Engagement: CTTI Recommendations for Successful Collaborations Between Sponsors and Patient Groups Around Clinical Trials | Therapeutic Innovation and Regulatory Science | 2018 | 35 |
32 | Evaluating Source Data Verification as a Quality Control Measure in Clinical Trials | Therapeutic Innovation and Regulatory Science | 2014 | 33 |
33 | Mobile Medical Applications for Dosage Recommendation, Drug Adverse Reaction, and Drug Interaction: Review and Comparison | Therapeutic Innovation and Regulatory Science | 2017 | 33 |
34 | Recent Developments in the Prevention and Treatment of Missing Data | Therapeutic Innovation and Regulatory Science | 2014 | 32 |
35 | Quantum of Effectiveness Evidence in FDA’s Approval of Orphan Drugs: Update, July 2010 to June 2014 | Therapeutic Innovation and Regulatory Science | 2015 | 32 |
36 | Patient 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 Science | 2016 | 32 |
37 | Patient Centricity and Pharmaceutical Companies: Is It Feasible? | Therapeutic Innovation and Regulatory Science | 2017 | 31 |
38 | Value of Developing Plain Language Summaries of Scientific and Clinical Articles: A Survey of Patients and Physicians | Therapeutic Innovation and Regulatory Science | 2018 | 31 |
39 | New Benchmarks Characterizing Growth in Protocol Design Complexity | Therapeutic Innovation and Regulatory Science | 2018 | 31 |
40 | Practical Considerations and Recommendations for Master Protocol Framework: Basket, Umbrella and Platform Trials | Therapeutic Innovation and Regulatory Science | 2021 | 31 |
41 | Measuring the Impact of Patient Engagement and Patient Centricity in Clinical Research and Development | Therapeutic Innovation and Regulatory Science | 2020 | 30 |
42 | Attention-Deficit Hyperactivity Disorder and Pharmacotherapy—Past, Present, and Future: A Review of the Changing Landscape of Drug Therapy | Therapeutic Innovation and Regulatory Science | 2015 | 28 |
43 | CBER’s Experience With Adaptive Design Clinical Trials | Therapeutic Innovation and Regulatory Science | 2016 | 28 |
44 | Neonatal Safety Information Reported to the FDA During Drug Development Studies | Therapeutic Innovation and Regulatory Science | 2018 | 27 |
45 | Utilizing Advanced Technologies to Augment Pharmacovigilance Systems: Challenges and Opportunities | Therapeutic Innovation and Regulatory Science | 2020 | 27 |
46 | Evaluation of Blinded Independent Central Review of Tumor Progression in Oncology Clinical Trials: A Meta-analysis | Therapeutic Innovation and Regulatory Science | 2013 | 26 |
47 | Patient Engagement by Pharma—Why and How? A Framework for Compliant Patient Engagement | Therapeutic Innovation and Regulatory Science | 2015 | 26 |
48 | Ten-Year Experience for the Center for Drug Evaluation and Research, Part 2: FDA’s Role in Ensuring Patient Safety | Therapeutic Innovation and Regulatory Science | 2017 | 26 |
49 | Communicating Benefit and Risk Information in Direct-to-Consumer Print Advertisements: A Randomized Study | Therapeutic Innovation and Regulatory Science | 2015 | 25 |
50 | A Universal Framework for the Benefit-Risk Assessment of Medicines: Is This the Way Forward? | Therapeutic Innovation and Regulatory Science | 2015 | 25 |