Emergence of the Joint Clinical Assessment in the European Union Sweeping developments in HTA and their impact on pharmaceutical and medtech manufacturers
Navigating EU Joint Clinical Assessments and Joint Scientific Consultations From January 2025 Onward What Do We Need to Know About Joint Clinical Assessments (JCAs)?
IPECAD Cross Comparison Challenge on Cost-Effectiveness Models in Alz Disease and Related Dementias Improving the transparency and credibility of cost-effectiveness models for AD
Submission Requirements of Nordic HTA Organizations for Medical Technologies A study to assess the range of medical technology requirements in Nordic health technology assessment processes
Modelling Considerations for Evaluating the Cost-Effectiveness of Biologics Challenges in designing conceptual models for biologic therapies in eosinophilic-associated diseases
How Much Does TLV Value Rarity? A Review of Reimbursement Determining if the rarity of conditions affected incremental cost-effectiveness ratios in Sweden
Differences and Similarities of Health Economic Evaluation for Medical Technologies by HTA Bodies Understanding the requirements for HTA economic evaluations
HTA Processes for Medical Technologies Across the World – Are All Hurdles the Same? We evaluated similarities and differences in Europe, North America, South America, Asia, and Oceania
Trends in the Inclusion of Patient Reported Outcomes in Oncology Clinical Trials We studied industry-sponsored oncology clinical trials from 2013 through 2022
Equity, Diversity, Inclusion, and Belonging in Patient Centered Drug Development Applying EDIB principles can support more equitable health outcomes.
How Do We Get Drug Labeling Based on Patient Reported Outcomes? We must first decide, "what's the value proposition - in simple language?"
How are United States ICER'S Evidence Ratings Determined? A systematic review of ICER'S evidence ratings for new drugs in 2020-2021
Adverse Cardiac Events in COPD Patients Treated with Inhaled Bronchodilators Evaluation of cardiovascular safety endpoints related to the use of aclidinium
Informing Gestational Age in Pregnancy Research without Clinical Estimates Providing estimates of gestational age at birth when clinical estimates of gestational age are not available
Tailoring Cost-Effectiveness Modeling Methodologies for Multiple Sclerosis Designing and conducting studies that explicitly account for the eventual requirements of MS
Causal Inference Methods for Real-World Evidence Please join Xabier Garcia de Albeniz for this recorded 30-minute workshop
Real-World Evidence You Need, When You Need It Utilizing available data sources to demonstrate product value
Incorporating Real-World Evidence Into Your Product Development See how RTI Health Solutions can partner with you to make the most of your real-world evidence when generating evidence for your drug or medical device development.
Using Real-World Evidence for Comparative Safety Studies Generating valid RWE requires thoroughly understanding underlying real-world data
2020 FDA Patient-Reported Outcomes Guidance Draft Development, evaluation, and regulatory review of clinical outcome assessments
Assessing the Quality of Data from Stated-Preference Surveys Generating reliable data by ensuring respondents understand survey questions
Antidepressant Drug Utilization Study Describing the use of antidepressants in Europe and the characteristics of adult users
Assigning Treatment Strategy Using Real-World Data When using observational data, quantifying the effect of treatment strategies that are sustained over time is not straightforward
Identifying Psychosis in Patients with Dementia Assessing antipsychotics' mortality risk can be challenging in automated healthcare databases
Coding Variations Hinder Vaccine Efficacy and Safety Research Researchers should evaluate accuracy of real-world data to be included in studies
HTA and Reimbursement Considerations for Orphan Drugs in European Markets Recommendations to manufacturers on evidence sources and techniques
Identifying a Drug's Safety Profile Antiepileptic drugs in pregnancy: pregnancy duration, birth weight, length, and head circumference
Determining Effectiveness of Risk-Minimization Measures Evaluating the effectiveness of implementation of EMA recommendations
Longitudinal Modeling Approaches to Assess Association Between Two Clinical Outcomes Assessments Robust analysis approaches, such as the joint MMRM
