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Systematic Review of Patient Focused Drug Development Meeting Reports for Conditions Affecting Neurodevelopment
Systematic Review of Patient Focused Drug Development Meeting Reports for Conditions Affecting Neurodevelopment
Researchers of rare diseases affecting neurodevelopment struggle with concept and outcome assessment identification issues...
Challenges and Potential Solutions to Advance Global Cancer Drug Development
Challenges and Potential Solutions to Advance Global Cancer Drug Development
Despite recent advancements in oncology drug development, patient access to innovative cancer therapies remains inadequate...
Assessing the Contribution of Components in Late-Phase Oncology Trials: A Roadmap of Key Approaches
Assessing the Contribution of Components in Late-Phase Oncology Trials: A Roadmap of Key Approaches
Combination therapies are increasingly prevalent in oncology drug development, yet demonstrating the contribution of each ...
Incorporating Patient Perspectives into Structured Benefit-Risk Assessment: A Drug Development Framework Recommendation
Incorporating Patient Perspectives into Structured Benefit-Risk Assessment: A Drug Development Framework Recommendation
Regulatory agencies have been promoting the incorporation of the patient perspective into benefit-risk assessment to bette...
Challenges in Conducting Quantitative Patient-Centered Benefit-Risk Assessments: A Case Study in Ph + ALL with Immature Efficacy Data
Challenges in Conducting Quantitative Patient-Centered Benefit-Risk Assessments: A Case Study in Ph + ALL with Immature Efficacy Data
Quantitative benefit-risk assessment (qBRA) can reveal how patients balance benefits and risks of cancer treatments. To al...
Ethical Challenges and Considerations in Decentralized Clinical Trials (DCTs): Insights from a Scoping Review
Ethical Challenges and Considerations in Decentralized Clinical Trials (DCTs): Insights from a Scoping Review
Decentralized clinical trials (DCTs) leverage digital health technologies to conduct trials outside traditional settings, ...
Enhancing Data Quality in Clinical Trials: Cross-Company Validation of the Open-Source Clinical Trial Anomaly Spotter (CTAS)
Enhancing Data Quality in Clinical Trials: Cross-Company Validation of the Open-Source Clinical Trial Anomaly Spotter (CTAS)
Current ICH guidelines, e.g. ICH E6 (R3), advocate a risk-based statistical review of clinical trial data to iden...
An NCI Micro-credentialing Model for Onboarding and Training Clinical Research Professionals in a Lean Fiscal Environment
An NCI Micro-credentialing Model for Onboarding and Training Clinical Research Professionals in a Lean Fiscal Environment
Clinical research professionals are essential to the successful conduct of clinical trials yet training and retention of t...
Impurities in Oncology Pharmaceuticals: A Review of Classification, Detection Methods, Regulatory Frameworks and Emerging Trends
Impurities in Oncology Pharmaceuticals: A Review of Classification, Detection Methods, Regulatory Frameworks and Emerging Trends
Pharmaceutical impurities pose a significant challenge in the development and manufacturing of anti-cancer drugs due to th...
-Controlled Trials: Robust to Confounding and
-Controlled Trials: Robust to Confounding and
External evidence from prior trials, registries, and fit-for-purpose real-world data can improve drug development efficien...
Research on the Quality Evaluation Indicators of Real-World Data in the Review of Anti-Tumor Drugs for Chinese Regulatory Frameworks
Research on the Quality Evaluation Indicators of Real-World Data in the Review of Anti-Tumor Drugs for Chinese Regulatory Frameworks
This study addresses the quality of real-world data (RWD) in oncology and proposes a comprehensive evaluation system for a...
Regulatory Approaches to Electronic Labelling in the USA, EU, and India: A Comparative Overview
Regulatory Approaches to Electronic Labelling in the USA, EU, and India: A Comparative Overview
In this era of growth, e-labelling is becoming increasingly important as the labels are important sources of information f...
Strategic Integration of Companion Diagnostics in Precision Oncology: Key Factors, Drug Development Timelines, and Regulatory Insights from U.S. FDA Approvals
Strategic Integration of Companion Diagnostics in Precision Oncology: Key Factors, Drug Development Timelines, and Regulatory Insights from U.S. FDA Approvals
Companion diagnostics (CDxs) are central to precision oncology, enabling identification of patients most likely to benefit...
Parents' Perspectives on Access to Pediatric Rare Disease Cross-Border Clinical Trials in Europe: Experiences of Language Inclusion and Preferences
Parents' Perspectives on Access to Pediatric Rare Disease Cross-Border Clinical Trials in Europe: Experiences of Language Inclusion and Preferences
Access to cross-border clinical trials may represent the sole therapeutic option for children living with rare diseases fo...
Advancing Platform Trials in Early Oncology by Using MATS and EXNEX in Randomized Controlled Trials
Advancing Platform Trials in Early Oncology by Using MATS and EXNEX in Randomized Controlled Trials
The randomized controlled trial (RCT) is widely regarded as the gold standard in clinical development due to its ability t...
Application of Artificial Intelligence in MedDRA Coding: A Practical Exploration from Clinical Data Management Perspective
Application of Artificial Intelligence in MedDRA Coding: A Practical Exploration from Clinical Data Management Perspective
Traditional manual MedDRA coding in clinical data management (CDM) faces persistent challenges, including suboptimal site ...
Treatment Comparison for a Single Arm Study Utilizing External Control: Performing Inference when Imputing Potential Outcomes
Treatment Comparison for a Single Arm Study Utilizing External Control: Performing Inference when Imputing Potential Outcomes
Non-randomized comparative studies are often used to compare treatment effects between an investigational product and a co...
Assessing the Malaysian Regulatory Process for Medicinal Product Approval: An OpERA Methodology and Standardized Reporting Approach
Assessing the Malaysian Regulatory Process for Medicinal Product Approval: An OpERA Methodology and Standardized Reporting Approach
The Malaysian National Pharmaceutical Regulatory Agency (NPRA) has partnered with the Centre for Innovation in Regulatory ...
Incorporating Patient Needs and Perspectives in Additional Risk Minimization Measures and Other Pharmacovigilance Deliverables - A Framework and Implementation Roadmap
Incorporating Patient Needs and Perspectives in Additional Risk Minimization Measures and Other Pharmacovigilance Deliverables - A Framework and Implementation Roadmap
Various initiatives and guidelines exist to support patient engagement (PE) throughout the lifecycle of a medicinal produc...
Longitudinal Descriptive Analysis of Dynamic Changes in Safety Concerns in Japanese Risk Management Plans for Medicinal Products Over 8 Years After Approval
Longitudinal Descriptive Analysis of Dynamic Changes in Safety Concerns in Japanese Risk Management Plans for Medicinal Products Over 8 Years After Approval
A Japanese risk management plan (RMP) is a proactive planning tool for managing safety concerns (important identified risk...
Characterizing Gene Therapy Medicinal Products Post-Marketing Safety Reports Based on WHO Pharmacovigilance Database, VigiBase
Characterizing Gene Therapy Medicinal Products Post-Marketing Safety Reports Based on WHO Pharmacovigilance Database, VigiBase
Safety assessments of gene therapy medicinal products (GTMPs) require comprehensive data collection from a variety of sour...
Enhancing Development Strategies Through Early Scientific Advice from HTA Agencies–Experiences, Expectations and Best Practices from Health Technology Developers
Enhancing Development Strategies Through Early Scientific Advice from HTA Agencies–Experiences, Expectations and Best Practices from Health Technology Developers
Early health technology assessment (HTA) advice provides value to pharmaceutical companies during drug development by iden...
Ensuring Quality and Interpretability of Progression Free Survival and Overall Survival in Oncology Clinical Trials
Ensuring Quality and Interpretability of Progression Free Survival and Overall Survival in Oncology Clinical Trials
Time-to-event endpoints, such as progression free survival (PFS) and overall survival (OS), are critical in assessing ther...
Temporal Trends in the Prescription of Biosimilars and the Status of Switching from Original Biologics to Biosimilars at Individual and Institutional Levels in Japan
Temporal Trends in the Prescription of Biosimilars and the Status of Switching from Original Biologics to Biosimilars at Individual and Institutional Levels in Japan
To describe the temporal trends in the prescription of biologics in Japan, with additional analysis focusing on switching ...
Advancing Global Harmonization: Implementing Global Dose Form Attributes for Medicinal Products Identification
Advancing Global Harmonization: Implementing Global Dose Form Attributes for Medicinal Products Identification
The global pharmaceutical market includes a wide range of medicinal products, which makes it difficult to achieve consiste...
Insights on Clinical Development of Cell and Gene Therapy for Rare Diseases—by DahShu Innovative Design Scientific Working Group (IDSWG)
Insights on Clinical Development of Cell and Gene Therapy for Rare Diseases—by DahShu Innovative Design Scientific Working Group (IDSWG)
The rapid advancement of cell and gene therapies (CGT) in the past ten years has inspired biopharmaceutical companies, bio...
Impact of Protocol Amendments, Personnel Experience and Social Determinants of Health on Study Protocol Adherence in Clinical Trials with Combination Products
Impact of Protocol Amendments, Personnel Experience and Social Determinants of Health on Study Protocol Adherence in Clinical Trials with Combination Products
The amendments to the International Council for Harmonization (ICH) Good Clinical Practice (GCP) E8 guidelines were introd...
Adaptive Design with Bayesian Informed Interim Decisions: Application To a Randomized Trial of Mechanical Circulatory Support
Adaptive Design with Bayesian Informed Interim Decisions: Application To a Randomized Trial of Mechanical Circulatory Support
Cardiovascular and oncology trials increasingly require large sample sizes and long follow-up periods. Several approaches ...
Company Sponsored Platform Trials: Recommendations and Lessons Learned from Cross-Industry Interviews
Company Sponsored Platform Trials: Recommendations and Lessons Learned from Cross-Industry Interviews
In the evolving landscape of clinical research, platform trials have emerged as a revolutionary model, initially designed ...
Master Protocols: A Promising Approach to Accelerate Drug Development in Rare Kidney Diseases
Master Protocols: A Promising Approach to Accelerate Drug Development in Rare Kidney Diseases
Kidney diseases have been a highly challenging area for new drug development because of traditional requirements for reach...
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