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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...
RegionSizeR– A Novel App for Regional Sample Size Planning in MRCTs
RegionSizeR– A Novel App for Regional Sample Size Planning in MRCTs
In multi-regional clinical trials, planning the sample size for participating regions is essential for the evaluation of t...
Unleashing the Power of Reliance for Post-Approval Changes: A Journey with 48 National Regulatory Authorities
Unleashing the Power of Reliance for Post-Approval Changes: A Journey with 48 National Regulatory Authorities
Post-approval changes (PACs) to marketed products are routinely introduced to continuously enhance the product lifecycle m...
Leveraging Real-World Data in Safety Signal Assessment
Leveraging Real-World Data in Safety Signal Assessment
TransCelerate BioPharma surveyed its member biopharmaceutical companies to understand current practices and identify oppor...
A Comprehensive Framework for Evaluating the Value Created by Real-World Evidence for Diverse Stakeholders: The Case for Coordinated Registry Networks
A Comprehensive Framework for Evaluating the Value Created by Real-World Evidence for Diverse Stakeholders: The Case for Coordinated Registry Networks
This manuscript presents a comprehensive framework for the assessment of the value of real-world evidence (RWE) in healthc...
Efficiency of eSource Direct Data Capture in Investigator-Initiated Clinical Trials in Oncology
Efficiency of eSource Direct Data Capture in Investigator-Initiated Clinical Trials in Oncology
Clinical trials have become larger and more complex. Thus, eSource should be used to enhance efficiency. This study aimed ...
The Effect of Antihyperglycemic Medications on COVID-19: A Meta-analysis and Systematic Review from Observational Studies
The Effect of Antihyperglycemic Medications on COVID-19: A Meta-analysis and Systematic Review from Observational Studies
Diabetes, a chronic disease worldwide, may be associated with a poorer prognosis in patients with coronavirus disease 2019...
EU’s Medical Device Expert Panels: Analysis of Membership and Published Clinical Evaluation Consultation Procedure (CECP) Results
EU’s Medical Device Expert Panels: Analysis of Membership and Published Clinical Evaluation Consultation Procedure (CECP) Results
The new EU Medical Device Regulation (MDR) places greater importance on the role of clinical evidence to establish safety ...
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