This episode of tHEORetically Speaking features real-world evidence experts Alexandrina Balanean, Parisa Asgarisabet, and Danielle Gentile from Cardinal Health discussing the problems caused by lack of diverse representation in clinical trials.
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 biologics have some degree of hepatoxicity.
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 stored in the UK. A majority, however, do not feel comfortable with their data being processed using artificial intelligence (AI).
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 evidence (RWE) and randomized controlled trials (RCTs) covering over 4800 patients.
In a recent interview with Clinical Leader, Harsha Rajasimha, 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 real-world data (RWD) that can be used in research, but doing so requires collaboration between all stakeholders.
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 coordination with the Institut national d’excellence en santé et en services sociaux (INESSS) and Canada Health, will help align RWE and RWD usage with regulatory bodies and health technology assessment (HGA) agencies.
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 approval applications.
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 Oncology QCARD Initiative.
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 use in early drug development still faces uncertainties.
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 address one of the biggest challenges facing clinical trials – recruitment.
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 in blood. RWE from the ZORA study shows that few patients have their RAASi medications reinitiated after a hyperkalemia event, which is associated with a two times increase in mortality.
As more companies are utilizing real-world data (RWD) and real-world evidence (RWE) for drug development and market access, new strategies are needed to sift through massive data pools to identify actionable insights. In a new IQVIA blog post, learn about how a research team used artificial intelligence and knowledge graphs to identify key stakeholders in digital health policy data.
Flatiron Health has announced it has formed a partnership with a key hospital trust in Europe, the Leeds Teaching Hospitals NHS Trust (LTHT). In the partnership, Flatiron will help researchers and clinicians turn unstructured cancer information into high-quality real-world data (RWD) and real-world evidence to help drive decision-making and research efforts.
As prescription drug spending is on the rise in China, coverage decisions are becoming increasingly important and more complex with the advent of new of high-cost, high-reward therapeutics. In a new article in The BMJ, learn more about the role that real-world evidence (RWE) is playing in the reimbursement decision-making process.
Difficulties in assessing the quality of real-world evidence (RWE) limit its application in regulatory decision-making and clinical development. To this end, a group of experts put together a new tool that provides a standardized approach to RWE quality assessment. In a new interview on The Evidence Base, experts talked about this new tool and the potential impact it may have on the field going forward.
In a debate at this year’s European Hematology Association Congress, experts discussed whether and how real-world data (RWD) could replace clinical trials in hematology. According to moderator Phillipe Rousselot, MD, RWD better accounts for the diversity of patients, making the data more applicable to real-world patient populations.
COVID-19 has long-term repercussions for patients who recover, but these effects are poorly characterized. In a newly published study in The Lancet, researchers examined the health outcomes of patients 6 months after being discharged from a hospital in Wuhan, China for COVID-19. The study, which examined data from 2469 patients, found that many patients experienced muscle weakness, sleep disturbances, or mental health issues.
Biosimilars have opened up access to expensive but lifesaving biologics in recent years, but some payer organizations, providers, and regulatory agencies have reservations about them. Real-world evidence (RWE) has the potential to accelerate uptake of biosimilars. In a new interview with Delphine Courmier of Organon, learn more about the importance of RWE for biosimilar adoption.
Real-world evidence (RWE) is a key part of a successful product launch or indication expansion, but doing so requires a careful strategy to maximize efficiency and minimize costs. In a new article by Richard Hallquist of IQVIA, learn about how to build an evidence strategy that maximizes the odds of an excellent launch.
According to Medicare Director Meena Seshamani, upcoming drug pricing negotiations will take the patient perspective and real-world evidence (RWE) into account. The agency wants to incorporate information about how high prices of key therapeutics impacts patients, as well as how the drugs are used and work in real-world settings.
Korea’s Ministry of Food and Drug Safety is now accepting real-world evidence (RWE) as clinical data for medical device approval decision-making. This opens up a pathway for medical device manufacturers to accelerate development with real-world data (RWD) resources like clinical data from devices, electronic health records (EHR), and claims data.
A real-world data study published in AIDS found that three two-drug dolutegravir combination therapies were as effective in managing HIV as commonly used three-drug treatment regimens. The study covered over 3,000 patients from 2015 and 2021 taking dolutegravir in combination with lamivudine, rilpivirine, and emtricitabine.
A recent real-world data study published in the Journal of Dermatological Treatment finds that patients with psoriasis change up their biologic therapeutics. Claims data from nearly 8,000 patients taken revealed that, on average, 14.4% of patients changed biologics within 12 months of the study’s two year period, while over a quarter swapped by 24 months.
Two real-world evidence (RWE) studies published in Diabetes Therapy and Diabetes Technology and Therapeutics found that 2 daily blood glucose measurements with Lifescan’s OneTouch Verio Reflectt® glucose monitoring device and accompanying OneTouch Reveal® app are associated with improved glycemic control in patients with either type 1 or type 2 diabetes. The study covered 55,000 patients with diabetes over 180 days.