SCI Abstract

search
+
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...
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...
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...
-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...
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...
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...
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 ...
Bioequivalence of Generic Semi-solid Topical Dermatological Drug Products: Scientific and Regulatory Perspective from Japan’s 2025 Guidelines
Bioequivalence of Generic Semi-solid Topical Dermatological Drug Products: Scientific and Regulatory Perspective from Japan’s 2025 Guidelines
This review examines Japan’s 2025 revision of bioequivalence (BE) guidelines for semi-solid topical dermatological d...
Ethical and Regulatory Awareness of Clinical Trials: A Nationwide Cross-Sectional Study from Poland
Ethical and Regulatory Awareness of Clinical Trials: A Nationwide Cross-Sectional Study from Poland
Clinical trials are conducted under rigorous ethical and regulatory frameworks to protect participants, including ethics c...
Precision in Pharmacoeconomics: A Comparative Cost-Utility Analysis of Osimertinib in EGFR-Mutant NSCLC Using Traditional and Pharmacometric Models
Precision in Pharmacoeconomics: A Comparative Cost-Utility Analysis of Osimertinib in EGFR-Mutant NSCLC Using Traditional and Pharmacometric Models
Health technology assessments (HTAs) for targeted therapies like osimertinib require models capturing individual pharmacok...
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...
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 ...
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...
A Real-World Disproportionality Analysis of FDA Adverse Event Reporting System Events for Tazemetostat
A Real-World Disproportionality Analysis of FDA Adverse Event Reporting System Events for Tazemetostat
Tazemetostat, an EZH2 inhibitor approved for select sarcomas and lymphomas, has limited post-marketing safety data despite...
BOP2-Comb: Bayesian Optimal Phase II Design for Optimizing Doses and Assessing Contribution of Components in Drug Combinations
BOP2-Comb: Bayesian Optimal Phase II Design for Optimizing Doses and Assessing Contribution of Components in Drug Combinations
Personalized cancer treatment using combination therapies offers substantial therapeutic benefits over single-agent treatm...
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...
Implementation of Established Conditions and Use of Quality by Design Principles during Drug Development: Status in the US, EU, and Japan. Data from a Survey Conducted by the Japan Pharmaceutical Manufacturers Association (JPMA)
Implementation of Established Conditions and Use of Quality by Design Principles during Drug Development: Status in the US, EU, and Japan. Data from a Survey Conducted by the Japan Pharmaceutical Manufacturers Association (JPMA)
The JPMA conducted a survey among its member companies regarding the use of Established Conditions (ECs) under ICH Q12. EC...
Patient Safety in Healthcare: A Proposal for Ensuring the Use of Regulation-Compliant Safety Devices
Patient Safety in Healthcare: A Proposal for Ensuring the Use of Regulation-Compliant Safety Devices
Medical devices used in health care should fulfill the requirements of the technical regulations to protect patient health...
Measuring Patient Participation Burden in Clinical Outcome Assessments for Clinical Trials
Measuring Patient Participation Burden in Clinical Outcome Assessments for Clinical Trials
Bristol Myers Squibb (BMS), in collaboration with ZS and Tufts CSDD, recently conducted a detailed evaluation of participa...
Machine Learning in Tuberculosis Research: A Global Bibliometric Analysis of Diagnostic, Prognostic, and Drug Discovery Trends
Machine Learning in Tuberculosis Research: A Global Bibliometric Analysis of Diagnostic, Prognostic, and Drug Discovery Trends
Tuberculosis (TB) remains a major global health challenge, driving the need for innovative approaches in diagnosis and dru...
Descriptions of Abnormal Kidney Function in Contraindications: A Cross-Sectional Analysis of Japanese Prescription Drug Labeling Under the New Format
Descriptions of Abnormal Kidney Function in Contraindications: A Cross-Sectional Analysis of Japanese Prescription Drug Labeling Under the New Format
In Japan, prescription drug labeling has transitioned to a new structured format aimed at improving clarity and consistenc...
Load More
format_indent_increase