| Advancing a Framework for Regulatory Use of Real-World Evidence: When Real Is Reliable |
17 |
| Minimizing Patient Burden Through the Use of Historical Subject-Level Data in Innovative Confirmatory Clinical Trials: Review of Methods and Opportunities |
14 |
| Assessing the Financial Value of Patient Engagement: A Quantitative Approach from CTTI's Patient Groups and Clinical Trials Project |
14 |
| A Comparative Safety Profile Assessment of Oncolytic Virus Therapy Based on Clinical Trials |
6 |
| US Medical Information Websites Benchmarking: How Is the Industry Fairing in Usability? |
6 |
| Sources of Safety Data and Statistical Strategies for Design and Analysis: Clinical Trials |
5 |
| New Benchmarks Characterizing Growth in Protocol Design Complexity |
5 |
| Benefits and Risks of Nonsteroidal Anti-inflammatory Drugs: Methodologic Limitations Lead to Clinical Uncertainties |
4 |
| Patient Experience Data in US Food and Drug Administration (FDA) Regulatory Decision Making: A Policy Process Perspective |
4 |
| Ethical Issues in Research Involving Participants With Opioid Use Disorder |
4 |
| Mobile Health Applications for Caring of Older People: Review and Comparison |
4 |
| Mobile Health Applications for Pediatric Care: Review and Comparison |
4 |
| Accelerating Adoption of Patient-Facing Technologies in Clinical Trials: A Pharmaceutical Industry Perspective on Opportunities and Challenges |
4 |
| The Rules of Engagement: CTTI Recommendations for Successful Collaborations Between Sponsors and Patient Groups Around Clinical Trials |
4 |
| Public Understanding and Awareness of Isotretinoin Use and Safety in Al Ahsa, Eastern Saudi Arabia |
4 |
| Measurement Equivalence of Patient-Reported Outcome Measures Migrated to Electronic Formats: A Review of Evidence and Recommendations for Clinical Trials and Bring Your Own Device |
3 |
| Pharma Collaboration for Transparent Medical Information (phactMI) Benchmark Study: Trends, Drivers, Success Factors, and Value of Globalization in Medical Information |
3 |
| Incorporating Innovative Techniques Toward Extrapolation and Efficient Pediatric Drug Development |
3 |
| Expediting Drug Development: FDA's New Regenerative Medicine Advanced Therapy Designation |
3 |
| The Safety Explorer Suite Interactive Safety Monitoring for Clinical Trials |
3 |
| Anticancer Drug Prescription Patterns in Japan Future Directions in Cancer Therapy |
3 |
| Strengthening Health Products Regulatory Systems to Enhance Access to Quality Health Products in the Asia-Pacific |
3 |
| Biomaterials Evaluation: Conceptual Refinements and Practical Reforms |
3 |
| Quality Risk Management Framework: Guidance for Successful Implementation of Risk Management in Clinical Development |
3 |
| Unresectable and Metastatic Melanoma of the Skin: Literature Review of Clinical Trials and Efficacy Endpoints Since 2000 |
3 |
| Adverse Reactions to Radiopharmaceuticals: A Survey Based on Clinical Cases Using Criteria of Systematic Review |
3 |
| Sources of Safety Data and Statistical Strategies for Design and Analysis: Real World Insights |
3 |
| Sources of Safety Data and Statistical Strategies for Design and Analysis: Postmarket Surveillance |
3 |
| Value of Developing Plain Language Summaries of Scientific and Clinical Articles: A Survey of Patients and Physicians |
3 |
| The Regulatory Review Process in South Africa: Challenges and Opportunities for a New Improved System |
3 |
| The Meanings of Pediatric Drug Development |
3 |
| Reports to Independent Data Monitoring Committees: An Appeal for Clarity, Completeness, and Comprehensibility |
2 |
| Insights and Best Practices for Planning and Implementing Patient Advisory Boards |
2 |
| Effective Partnering in Conducting Benefit-Risk Patient Preference Studies: Perspectives From a Patient Advocacy Organization, a Pharmaceutical Company, and Academic Stated-Preference Researchers |
2 |
| The Near-Term Viability and Benefits of eLabels for Patients, Clinical Sites, and Sponsors |
2 |
| Research Misconduct in FDA-Regulated Clinical Trials: A Cross-sectional Analysis of Warning Letters and Disqualification Proceedings |
2 |
| Assessing Study Start-up Practices, Performance, and Perceptions Among Sponsors and Contract Research Organizations |
2 |
| Industry and Patient Perspectives on Child Participation in Clinical Trials: The Pediatric Assent Initiative Survey Report |
2 |
| Statistical Interactions in a Clinical Trial |
2 |
| Comparison of International Regulations for Written Medicine Information (WMI) on Prescription Medicines |
2 |
| Improving Expanded Access in the United States: The Role of the Institutional Review Board |
2 |
| Development of Prescription Drug Information Leaflets: Impact of Cognitive Effort and Patient Involvement on Prescription Medication Information Processing |
2 |
| A Pilot Experiment in Responding to Individual Patient Requests for Compassionate Use of an Unapproved Drug: The Compassionate Use Advisory Committee (CompAC) |
2 |
| How Does Regulatory Practice Create Discrepancies in Drug Label Information Between Asian and Western Countries? Different Label Information for Direct Oral Anticoagulants Approved in the United States, Europe, Korea, and Japan |
2 |
| Awareness and Collaboration Across Stakeholder Groups Important for eConsent Achieving Value-Driven Adoption |
2 |
| Use of Proxy Variables to Determine the Impact of Protocol Complexity on Clinical Research Site Productivity |
2 |
| 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 |
2 |
| Extrapolation of Efficacy in Pediatric Drug Development and Evidence-based Medicine: Progress and Lessons Learned |
2 |
| What to Know About Medicines With New Active Ingredients Approved in FY 2016/2016 in Japan and EU: A Brief Comparison of New Medicines Approved in Japan and the EU in 2016 |
2 |
| Perceived Burden of Completion of Patient-Reported Outcome Measures in Clinical Trials:: Results of a Preliminary Study |
2 |
