EMA has recently launched the MINERVA project aimed at strengthening the use of real-world data in medicines development. RTI Health Solutions researchers will coordinate the project.
Updates
Please join Xabier Garcia de Albeniz for this recorded 30-minute case-study workshop on the use of causal inference methods for real-world evidence.
18 years of studies has essentially ruled out any but a small potential increase in risk of osteosarcoma. Due to the strength of the findings and other post-marketing experience, the drug sponsor was able to end their post-market commitment five years ahead of schedule.
The launch of the SIGMA Consortium heralds a new era of collaboration to better understand safety and effectiveness of medical interventions. SIGMA aims to integrate expertise and data from multiple European Research Centres.
We're excited to have reached this milestone in our journey of providing uncompromisingly ethical and objective research to help our clients understand the benefits, risks, value, and potential of their products.
The best practices outlined by this draft guidance should be considered when evaluating PROs intended to support drug submissions as well as medical devices.
RTI-HS will be participating in a feasibility analysis of an EU infrastructure for COVID-19 vaccine monitoring.
This document provides guidance on determining go/no go decisions, understanding potential threats to the validity of the research, and alternative data-collection methods for capturing patient experience data.
RTI has closed on its acquisition of Medical Data Analytics (MDA), a provider of real-world evidence (RWE) generation to the pharmaceutical and biotechnology industry. The acquisition expands existing services of RTI Health Solutions.
Recurring ear infections in children are not only frustrating and painful–they can also cause serious complications. If antibiotics do not successfully treat an ear infection or if infections continue to occur, a physician may recommend the insertion of ear tubes.
Answers to key questions about the communication of information for unapproved products as well as unapproved uses of approved products.
Our new office in Lyon, France, enhances our capabilities in real-world evidence generation. Welcome to the newest members of the RTI Health Solutions team.
In this study, we explored an alternative to cloning, based on randomly allocating people to either strategy.
As a result of these findings, a validated coding algorithm updated to ICD-10 codes to identify psychosis associated with dementia is recommended.
Josephine Mauskopf has been awarded the Marilyn Dix Smith Leadership Award by ISPOR.
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 underutilized.
The recent FDA guidance opens up a communication channel that hasn’t existed before. Manufacturers who discuss reimbursement with payers before approval may improve their product access.
The AD PACE initiative is a first-of-its-kind collaboration among pharmaceutical companies, advocacy organizations, academic institutions and care services companies to understand which outcomes matter to individuals and to use that information to develop treatments to improve patients’ lives.
The goal of the European Network of Centers for Pharmacoepidemiology and Pharmacovigilance (ENCePP) is to facilitate independent and transparent post-authorization monitoring of medicinal products in Europe.
Join RTI Health Solutions researchers as they teach Budget Impact Analysis.
Allen Mangel, MD, PhD, and Executive VP of RTI-HS, examines evidence that supports a different understanding of the behavior of the aorta during the cardiac cycle.
RTI Health Solutions is pleased to announce that Ken Rothman, DrPH, Distinguished Fellow and Vice President for Epidemiology Research, has been awarded the Career Accomplishment Award by the Society for Epidemiologic Research.
This webinar explores the trends in PRO-related product labeling and highlights key observations. Knowing the trends and the lessons learned from this review of US product labeling will enable you to formulate better PRO labeling strategies.
RTI Health Solutions has joined a collaborative led by the Medical Device Innovation Consortium that will work with Parkinson’s patients to determine the benefit and risk tradeoffs they are willing to make for potential new therapies.
Data from a head-to-head trial showed that LDX is a cost-effective treatment option compared with atomoxetine in children and adolescents who have had an inadequate response to the currently recommended first-line stimulant treatment.