Industry news round-up: updates from September 2024
Explore the latest advancements in real-world data (RWD), real-world evidence (RWE) and health technology assessment (HTA) as featured on The Evidence Base during September 2024.
Proscia introduces comprehensive real-world data offering for precision medicine
Proscia’s new RWD solution provides over 10 million pathology images integrated with clinical and genomic data to advance precision medicine.
Japan’s PMDA publishes perspective on RWD/RWE utilization for postmarketing drug safety assessment
In a new Commentary published in Pharmacoepidemiology and Drug Safety, authors from Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) reflect on the experience gained in recent years utilizing real-world data/evidence for regulatory decision-making on drug safety.
Truveta and the CHOICE Institute partner to advance HEOR using RWD
The Comparative Health Outcomes, Policy, and Economics (CHOICE) Institute at the University of Washington’s School of Pharmacy has announced a strategic partnership with Truveta, a leader in RWD analytics. This collaboration aims to enhance HEOR by leveraging Truveta’s comprehensive electronic health record (EHR) data to advance patient care and medical research.
New HealthVerity taXOnomy dataset combines RWD claims to advance pharmaceutical research
HealthVerity launches taXOnomy, a dataset combining closed and open claims to enhance pharmaceutical research with detailed patient insights.
The final report from the Center for Innovation & Value Research outlines steps to integrate equity into HTA, focusing on transparency, inclusivity, and addressing health disparities in decision-making.
Panalgo and COTA collaborate to advance cancer care with real-world oncology data
Panalgo is partnering with COTA to integrate high-quality hematologic oncology data into its IHD platform, enhancing cancer research and accelerating RWE generation.
Review of Australian HTA policy and methods prioritizes real-world evidence as a key reform
Enhancing timely access to relevant, quality RWD and RWE amongst the fifty recommendations made in the report examining Australian HTA policy and methods.
The FDA’s new draft guidance aims to support the conduct of randomized controlled trials by streamlining protocols and focusing on essential data collection, enabling the integration of research into routine clinical practice. Released as part of the FDA’s efforts to advance its Real-World Evidence Program, this guidance marks a significant step in making trials more accessible and efficient.
EMA finalizes their perspective of the use of single-arm trials for regulatory decision-making
The EMA has finalized their reflection paper on using single-arm trials submitted as key evidence in regulatory applications, while emphasizing that randomized controlled trials remain the ‘expected standard’ for establishing efficacy.
Flatiron Health UK partners with leading NHS trust to transform cancer care with real-world data
University Hospitals of Leicester NHS Trust and Flatiron Health UK will work together to leverage RWD for cancer research, improving treatments and patient outcomes.
EU adopts new guidance on clinical study validity for joint clinical assessments
The Member State Coordination Group on Health Technology Assessment adopted a new scientific guidance on the validity of clinical studies for joint clinical assessments during its tenth meeting on September 19, 2024.
