A real-world evidence (RWE) study published in Nature Scientific Reports assessed the hepatotoxicity of several major biologics, such as adalimumab, trastuzumab, IF-Beta 1a, and insulin glargine. The study, which used real-world data (RWD) from over 2 million patients, found that many of these key […]
UK Public Okay with NHS Data Storage with Some Reservations
The UK’s NHS generates massive amounts of real-world data (RWD) every day, but recently data security has become a concern. However, a recent survey found that 59% of participants feeling comfortable with the agency storing their data, although most (89%) felt it was important that the data was […]
Examining Representation Disparities in aRCC Clinical Trials
A recently published abstract in the Journal of Clinical Oncology examined patient populations in clinical trials for advanced renal cell carcinoma (aRCC), finding that significant underrepresentation based on age, ethnicity, and racial backgrounds. The study examined data from multiple real-world […]
Using Patient Registries to Accelerate Rare Disease Research
In a recent interview with Clinical Leader, , PhD, of the Indo US Organization for Rare Diseases (IndoUSrare) talks about the challenges facing rare disease research and how the use of patient registries can accelerate research and clinical development. Patient registries allow the collection of […]
Canadian Agency for Drugs and Technologies in Health Publishes Real-World Evidence Guidance
As real-world evidence (RWE) and real-world data (RWD) increasingly supplement data from randomized controlled trials (RCTs) in regulatory decision-making in Canada, the Canadian Agency for Drugs and Technologies in Health (CADTH) has issued a guidance for RWE reporting. The guidance, published in […]
Turning Real-World Data into Action in the NHS
Despite recent high-profile examples, biopharma startups face difficulties partnering with the UK’s NHS. This represents a missed opportunity due to the agency’s vast repository of healthcare real-world data (RWD), which could be used to accelerate drug development, value-assessment, and regulatory […]
US FDA Introduces the Oncology QCARD Initiative
Although real-world data (RWD) is increasingly being used in oncology for clinical development, safety evaluation, and regulatory decision-making, the widely varying data sources make quality evaluation difficult. To address this issue, the US Food and Drug Administration (FDA) has announced the […]
EMA Releases Report on Real-World Evidence
The European Medicines Agency published a report last week discussing the use of real-world evidence (RWE) in clinical trials and regulatory decisionmaking, the benefits it can provide, and the challenges in doing so. RWE, according to the report, is widely used in pharmacovigilance studies, but its […]
Verana Launches Real-World Evidence-Driven Clinical Trial Site Selection Platform
Verana Health has launched VeraSite, a new platform that uses real-world evidence (RWE) to help clinical trial sponsors select clinical trial sites. The tool uses electronic health records (EHR) to identify locations with large eligible patient populations. With this platform, Verana hopes to […]
New Real-World Evidence from AstraZeneca Finds Medication Discontinuation Worsens Hyperkalemia
New real-world evidence (RWE) presented at this year’s European Renal Association Congress explored hypokalemia care, finding that reduction or discontinuation of renin-angiotensin-aldosterone system inhibitor (RAASi) worsens outcomes of patients admitted for hyperkalemia (HK), high calcium levels […]
