Meet researcher Naoko Ronquest, Senior Director in our HE Modeling Program.
Research just published in Value in Health compares FDA and EMA labeling for evidence based on patient-reported outcomes (PROs) of new oncology treatments approved by both agencies.
Regulators and reimbursement authorities want to utilize real-world data more consistently to capture the real-world patient and clinician experience.
This paper describes study methods, challenges, and the study’s progress so far.
Research addressing concerns about the rising cost of health care in the United States
Reliance on statistical significance, and the related statistic, the P-value, is a drawback. Here are alternatives.
The RTI-HS Festive Cheer Score (FCS) is at its peak!
In 2014, a head-to-head clinical trial compared the 96-week efficacy and tolerability of three HIV multi-drug combinations commonly used as initial treatment for individuals with HIV-1 infection.
ISPOR Good Practices for Outcomes Research Provide Guidance for High-, Middle-, and Low-Income Countries
CADASIL, or cerebral autosomal dominant arteriopathy with subcortical infarcts and leukoencephalopathy, is a rare genetic disorder caused by mutations in the NOTCH3 gene. It is a neurological degenerative disorder leading to cognitive impairment and eventually vascular dementia.
Multiple myeloma (MM) is an incurable cancer of the bone marrow. It is the third-most-frequent blood cancer in the US, after lymphoma and leukemia. Several new therapies have recently been approved by the United States Food and Drug Administration (FDA) for treatment of MM, including daratumumab...
Patients with drug-resistant epilepsy (DRE) utilize more health care resources and face higher costs than patients who can control their condition with anti-epileptic drugs (AEDs). Despite the long-term proven effectiveness of vagus nerve stimulation (VNS), the treatment is currently...
Qualitative data on patients’ experiences and perspectives typically go uncollected in clinical trial settings. Yet patients’ treatment experiences offer complementary insights and context on topics such as disease management, treatment gaps, and previous treatments outside of those gathered in...
Often, drug manufacturers are faced with limited study data when developing therapies for rare diseases. To identify challenges in creating economic models, researchers at RTI Health Solutions coauthored a study that reviewed health technology assessment submissions for rare disease treatments...
Research on the impact of diabetes on quality of life often focuses on understanding the effect of specific interventions.
The PSA test is used to screen men for prostate cancer, however there is controversy around its poor sensitivity and specificity. It can lead to unnecessary biopsies and the overtreatment of low-grade cancers.
Communication of Pre-approval Information by Drug and Device Manufacturers to Payers in the US
It’s no longer business as usual. We are entering a new era of capturing patients’ voice in cancer drug development. It is critical to remain abreast of trends in the regulatory environment. Ari Gnanasakthy shares takeaways from FDA/ASCO workshop.
This new book serves as an essential reference for pharmacovigilance scientists and pharmacoepidemiologists searching for the appropriate study design to answer safety research questions in studies required by regulators. Two RTI Health Solutions (RTI-HS) researchers are contributors.
Biopharmaceutical Innovation Has Significant Impact, According to Physicians Surveyed. A recent survey of U.S. physicians provides insight on their perceptions regarding the impact of medical innovation on outcome
Soft tissue sarcoma (STS) is a rare group of malignant tumors comprising more than 50 histologic subtypes that are derived from connective tissues and other cells of mesenchymal origin. They account for approximately 1% of all incident malignancies.
Understanding What Matters Most to Alzheimer's patients and their caregivers to help inform the drug development process.
The Alzheimer’s Disease Patient and Caregiver Engagement (AD PACE) initiative is a first-of-its-kind collaboration among pharmaceutical companies, advocacy...
Research team members each have their own areas of expertise, which may not include experience with raw data. They all need tools they can understand to help them assess the data.
A small subgroup who have been on HIV treatment a long time have developed resistance to most currently available treatments