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Development of a Drug Safety Signal Detection Reference Set Using Japanese Safety Information
Development of a Drug Safety Signal Detection Reference Set Using Japanese Safety Information
One of the main objectives of pharmacovigilance activities is to confirm unknown adverse drug reactions (ADRs), and data-m...
Risk-Based Quality Management: A Case for Centralized Monitoring
Risk-Based Quality Management: A Case for Centralized Monitoring
Since 2019, the Association of Clinical Research Organizations has conducted a landscape survey of risk based quality mana...
Mixture Disease Progression Model to Predict and Cluster the Long-Term Trajectory of Cognitive Decline in Alzheimer’s Disease
Mixture Disease Progression Model to Predict and Cluster the Long-Term Trajectory of Cognitive Decline in Alzheimer’s Disease
Alzheimer’s disease (AD) is a neurodegenerative disease for which many clinical trials failed to detect treatment ef...
Data Monitoring Committee Reports: Telling the Data’s Story
Data Monitoring Committee Reports: Telling the Data’s Story
A Data Monitoring Committee (DMC) plays a pivotal role in monitoring participant safety and efficacy and overseeing the in...
Research on Core Competency Elements of Clinical Investigators
Research on Core Competency Elements of Clinical Investigators
To construct a competency model for clinical investigators involved in the process of new drug development, providing a re...
Turning the Page on Hardcopy Risk Management Plan Educational Materials: Digitalization Made Possible
Turning the Page on Hardcopy Risk Management Plan Educational Materials: Digitalization Made Possible
‘Risk Management Plan Educational Materials’ (RMP EMs) are additional risk minimization measures (aRMMs) inten...
Comparison of Borrowing Methods for Incorporating Historical Data in Single-Arm Phase II Clinical Trials
Comparison of Borrowing Methods for Incorporating Historical Data in Single-Arm Phase II Clinical Trials
Over the last few years, many efforts have been made to leverage historical information in clinical trials. Incorporating ...
Testing the Feasibility of a Digital Point of Care Solution for the Trusted Near Real-Time Bidirectional Exchange of Novel and Informative Adverse Event Information
Testing the Feasibility of a Digital Point of Care Solution for the Trusted Near Real-Time Bidirectional Exchange of Novel and Informative Adverse Event Information
A digital point-of-care solution was implemented to test the feasibility of near-real-time bi-directional communication be...
An Analysis of the Food and Drug Administration Manufacturer and User Facility Device Experience Database for MAGnetic Expansion Control Spinal Rods
An Analysis of the Food and Drug Administration Manufacturer and User Facility Device Experience Database for MAGnetic Expansion Control Spinal Rods
MAGnetic Expansion Control (MAGEC) rods can prevent repeated lengthening operations for scoliosis patients. However, there...
A Global Industry Survey on Post-Approval Change Management and Use of Reliance
A Global Industry Survey on Post-Approval Change Management and Use of Reliance
Post-approval changes (PACs) to the control and manufacturing processes of medicines and vaccines are routinely undertaken...
Insights into Early Interactions on Innovative Developments with European Regulators
Insights into Early Interactions on Innovative Developments with European Regulators
The European Medicines Agency Innovation Task Force (ITF) acts as early point of contact for medicine and technology devel...
Tips for Accelerating BOIN Design
Tips for Accelerating BOIN Design
During discussions at the Data Science Roundtable meeting in Japan, there were instances where the adoption of the BOIN de...
Expert Consensus Recommendations on a Biosimilars Value Framework for the Gulf Cooperation Council Countries
Expert Consensus Recommendations on a Biosimilars Value Framework for the Gulf Cooperation Council Countries
This paper aims to develop a biosimilar value framework with local stakeholders in Gulf Cooperation Council (GCC) countrie...
Pharmaceutical Company’s Choices of Indication for the First Clinical Projects in Oncological Drug Development in the United States
Pharmaceutical Company’s Choices of Indication for the First Clinical Projects in Oncological Drug Development in the United States
We analyzed factors shaping the choice of the lead indication (i.e., cancer type) in the first clinical development projec...
Hypocalcemia Event Associated with Denosumab: A Real-World Study from FDA Adverse Event Reporting System (FAERS) Database
Hypocalcemia Event Associated with Denosumab: A Real-World Study from FDA Adverse Event Reporting System (FAERS) Database
Denosumab is widely used for osteoporosis and cancer treatment. However, hypocalcemia induced by denosumab is a frequent a...
Open Innovation and Regulatory Challenges in New Modality Development: The Pivotal Role of Contract Development and Manufacturing Organisations in Advancing Antibody Drugs
Open Innovation and Regulatory Challenges in New Modality Development: The Pivotal Role of Contract Development and Manufacturing Organisations in Advancing Antibody Drugs
Ensuring regulatory-compliant manufacturing capability is an essential challenge for new treatment modalities, but its int...
Abstract Versus Concrete Risk Identification in Clinical Research in Japan: Randomized and Prospective Pilot Research on the Effect of Risk Reduction Activities in a Risk-Based Approach
Abstract Versus Concrete Risk Identification in Clinical Research in Japan: Randomized and Prospective Pilot Research on the Effect of Risk Reduction Activities in a Risk-Based Approach
The risk-based approach (RBA) of clinical trial was first introduced in 2011–2012. RBA necessitates implementing ris...
A Clustering Ensemble Method for Drug Safety Signal Detection in Post-Marketing Surveillance
A Clustering Ensemble Method for Drug Safety Signal Detection in Post-Marketing Surveillance
Post-marketing surveillance refers to the process of monitoring the safety of drugs once they reach the market, after the ...
Pediatric-Specific Drug Loss Issue in Japan: Comparison of Pediatric Development Status Between Japan and the United States
Pediatric-Specific Drug Loss Issue in Japan: Comparison of Pediatric Development Status Between Japan and the United States
The lack of label information for the pediatric population has been a global issue, leading to the introduction of several...
Pharmacometrics-Enhanced Bayesian Borrowing for Pediatric Extrapolation – A Case Study of the DINAMO Trial
Pharmacometrics-Enhanced Bayesian Borrowing for Pediatric Extrapolation – A Case Study of the DINAMO Trial
Bayesian borrowing analyses have an important role in the design and analysis of pediatric trials. This paper describes us...
Paediatric Drug Development in Japan: Current Status and Future Challenges
Paediatric Drug Development in Japan: Current Status and Future Challenges
Until around 2000, the number of medicinal products labelled for paediatric use was limited worldwide. Regulatory measures...
Comparison of Product Features and Clinical Trial Designs for the DTx Products with the Indication of Insomnia Authorized by Regulatory Authorities
Comparison of Product Features and Clinical Trial Designs for the DTx Products with the Indication of Insomnia Authorized by Regulatory Authorities
Digital therapeutics (DTx) have attracted attention as the substitutes or add-ons to conventional pharmacotherapy and the ...
A Framework for the Use and Likelihood of Regulatory Acceptance of Single-Arm Trials
A Framework for the Use and Likelihood of Regulatory Acceptance of Single-Arm Trials
Single-arm clinical trials (SAT) are common in drug and biologic submissions for rare or life-threatening conditions, espe...
Latest Developments in “Adaptive Enrichment” Clinical Trial Designs in Oncology
Latest Developments in “Adaptive Enrichment” Clinical Trial Designs in Oncology
As cancer has become better understood on the molecular level with the evolution of gene sequencing techniques, considerat...
Adopting a Framework for Rapid Real-World Data Analyses in Safety Signal Assessment
Adopting a Framework for Rapid Real-World Data Analyses in Safety Signal Assessment
The expanding availability of real-world data (RWD) has led to an increase in both the interest and possibilities for usin...
Delta Inflation, Optimism Bias, and Uncertainty in Clinical Trials
Delta Inflation, Optimism Bias, and Uncertainty in Clinical Trials
The phenomenon of delta inflation, in which design treatment effects tend to exceed observed treatment effects, has been d...
Using a Quality Management System and Risk-based Approach in Observational Studies to Obtain Robust Real-World Evidence
Using a Quality Management System and Risk-based Approach in Observational Studies to Obtain Robust Real-World Evidence
The results of observational studies using real-world data, known as real-world evidence, have gradually started to be use...
Harmonizing Quality Improvement Metrics Across Global Trial Networks to Advance Paediatric Clinical Trials Delivery
Harmonizing Quality Improvement Metrics Across Global Trial Networks to Advance Paediatric Clinical Trials Delivery
Despite global efforts to improve paediatric clinical trials, significant delays continue in paediatric drug approvals. Co...
Statistical Analysis for Rating Scale in Clinical Trials
Statistical Analysis for Rating Scale in Clinical Trials
In psychiatry clinical trials, an instrument or questionnaire with rating scale is often used to access safety and efficac...
Use of Seamless Study Designs in Oncology Clinical Development– A Survey Conducted by IDSWG Oncology Sub-team
Use of Seamless Study Designs in Oncology Clinical Development– A Survey Conducted by IDSWG Oncology Sub-team
Seamless study designs have the potential to accelerate clinical development. The use of innovative seamless designs has b...
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