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Navigating EU Joint Clinical Assessments and Joint Scientific Consultations From January 2025 Onward
… of the health technology assessment (HTA) process on a European level. Non-clinical HTA domains, which mainly … (EMA). The goal is endorsement of the final JCA report within 30 days of the European Commission decision to approve … studies. This includes fundamental criteria, such as patient populations, comparator selection, relevant …
… New Patient-Reported Outcomes Diary for Rare Acromegaly Disorder … February 27, 2023 Acromegaly Symptom Diary Acromegaly is a rare but serious condition caused by pituitary tumors that … (FDA) strongly encourages the use of PROs in clinical trials to accurately assess treatment benefits. …
… market research services include: Qualitative research (interviews and focus groups) with patients, physicians, and … and implementing consumer-based surveys Designing and conducting sensory panels Disseminating market research …
… We have experts who specialize in applying the target trial emulation framework to tackle these challenges. This … records Administrative healthcare claims Disease-specific clinical registries Linkages of claims and registries Sharing our Knowledge We are committed to being a resource for advancing epidemiological knowledge at all …
… for Drug-Resistant Epilepsy Share on: September 17, 2018 Patients with drug-resistant epilepsy (DRE) utilize more … has been available since 1997 and has been shown in clinical trials to be effective at reducing the number of … at RTI Health Solutions and LivaNova, PLC conducted a study to understand the long-term significance of these …
… Pharmacoepidemiology Studies Can Benefit From the Target Trial Emulation Framework Share on: February 12, 2024 By … which treatments are helpful or harmful. Randomized Clinical Trials Randomized clinical trials are the gold … or ethical (e.g., think of randomizing people to receiving a potentially life-saving treatment or not when no other …
… Strategy at RTI Health Solutions FDA Guidance In June 2018, the United States Food and Drug Administration (US FDA) … receive information from manufacturers well in advance of a product’s approval by the FDA so that they can make timely … of the product or new use Product pricing information Patient utilization projections (e.g., epidemiological data …
… 15th Clinical Trials on Alzheimer's Disease (CTAD) Share on: … at RTI Health Solutions, will be presented at the 15th Clinical Trials on Alzheimer's Disease. Economic burden of …
… and Marco Boeri of RTI Health Solutions have published a study in The Patient – Patient-Centered Outcomes Research that explores this subject …
… Emergence of the Joint Clinical Assessment in the European Union Anne Heyes, MBA … Europe. In addition, the European Union (EU) has proposed a sweeping revision of its pharmaceutical legislation – the … understand disease burdens, unmet medical needs, and patient preferences. We support clinical trial design by …