RWE

What’s the difference between a multimodal generative AI system to plan a vacation itinerary versus guiding cancer treatment? For the former, data quality is a definite plus, but for the latter, it’s indispensable. “If I ask ChatGPT to plan a vacation for me and it spits out something, I might sit there and second guess…

Utilizing real-world data (RWD) to generate real-world evidence (RWE) is not new and pharmacoepidemiologists have long-standing experience designing and implementing studies utilizing RWE to satisfy regulatory post-marketing safety commitments and to evaluate the effectiveness of drugs. However, RWD and RWE can be used more largely to support the full life cycle of drug development, during…

The healthcare industry traditionally has used site-based clinical trials to assess the efficacy and safety of drugs and medical devices. Data collected from patients participating in these site-based studies would be analyzed to evaluate the suitability of a medical product for commercial release. However, the exponential increase in patient data recorded by digital devices in…

Because adoption of real-world data (RWD) and real-world evidence (RWE) remains at an early stage, individual biopharma executives are likely to take a central role in ensuring that such data — and the related use of AI — are handled ethically. It becomes imperative that drug developers using RWD ensure transparency, apply consistent rules, peer…

The clinical trial landscape has evolved significantly in the past two years. But given the quick embrace of decentralized clinical trials and growing traction of apps, digital health and other technologies in the space, it can be difficult to separate hype from reality. To learn more about the evolving landscape, we caught up with Libbi…

The task of extracting health insights from electronic health records (EHRs) has taken longer to materialize than some pundits projected a decade or so ago. But the situation is quickly changing with continued advances in data science, said Sujay Jadhav, CEO of Verana Health (San Francisco), which has created a real-world data network in partnership…

While the present adoption of real-world data (RWD) and real-world evidence (RWE) remains early, such data promise to accelerate regulatory decision-making and support the approval of new indications for drugs already on the market.  “We’re now seeing real-world data being used and consulted almost 100% of the time to design a protocol for a study,”…

COVID-19 disrupted oncology clinical trials. More than a year into the pandemic, drug developers and regulators, including FDA, are also looking for ways to catalyze clinical trial innovation with AI and other tech. The FDA has been “vigilant as they always are to make sure that there is strong science, but they are much more…

Like a Category 5 hurricane, COVID-19 has uprooted traditional clinical trial methods to clear space for emerging models and practices to grow and flourish. Three related and complementary trends will have a profound and lasting impact. The shift to virtual/decentralized clinical trials. The popularity of decentralized clinical trials (DCTs) skyrocketed following the nationwide lockdown last March.…

Like most things in healthcare, clinical trials have been slow to evolve in recent decades. But the COVID-19 pandemic has forced clinical trial research teams to become more efficient, patient-centered and inclusive.   Much is at stake as the pandemic has already caused significant clinical trial disruption. EY estimates that the COVID-19 impact on Phase 3…