real-world evidence

Migraines, like many diseases, are not monolithic. In that regard, they are something like weather — they can shift suddenly, and predicting when they might arise can be elusive. Clinical trials traditionally capture a snapshot of the migraine storm, often failing to reflect the dynamic, lived experience of patients. Yet recent studies, including the phase…

Building on existing integrations with cloud leaders AWS and Google Cloud and collaborations with Arcadia and TD2, Atropos Health is now partnering with Merck. This new collaboration will tap Atropos Health’s GENEVA OS (Generative Evidence Acceleration Operating System) and related tools with the aim of speeding the generation of real-world evidence. Under the agreement, Merck’s…

Randomized controlled trials (RCTs) are the gold standard design for studies supporting drug approvals, but they are not always feasible, due to factors such as ethical concerns or very small patient populations.  When an RCT is not possible, researchers may opt for a single-arm trial (SAT), which does not include an internal control group, but…

In 2024, we saw the expanded use of synthetic data and natural language processing transform drug discovery and development. In a batch of predictions published in December of 2023, one expert predicted that synthetic data was set to “take off” in drug research. In 2025, the pendulum could begin swinging back the other way, according…

When it comes to medical AI, the biggest names aren’t necessarily delivering the best results. While tech giants race to build ever-larger language models, a new preprint reveals that when it comes to clinical accuracy and physician trust, a smaller player is outperforming the industry heavyweights. Putting large language model-based systems to the test Researchers…

In 2023, the American Society of Anesthesiologists (ASA) issued guidelines advising patients to discontinue GLP-1 receptor agonists (GLP1-RAs) a week before surgery, citing concerns over potential operative complications, leading to delayed or rescheduled surgeries across the U.S. Dr. David Klonoff, a diabetes researcher and Endocrinologist at Mill Peninsula Medical Center, thought it was curious that…

In the rapidly evolving landscape of drug development, real-world evidence (RWE) is making significant strides, finding its way into the early stages of the process. No longer confined to just the peri- and post-approval phases, RWE is now being tapped for external control arms (ECAs), aiding in health technology assessment (HTA), and informing payer discussions.…

Over the past decade, the use of deeper sources of real-world data across all stages of the drug development life cycle has become increasingly important to guide disease understanding, trial designs, clinical guidelines, regulatory submissions and post-market studies. The advent of these deeper sources was prompted by the HITECH Act, which had the effect of…

Synthetic data in oncology is transforming how researchers and developers approach real-world evidence. They often need this evidence to test hypotheses, predict outcomes and develop algorithms. But privacy constraints and access related to patient data can create delays and lengthen project timelines. Oncology drug researchers and developers have recently begun using synthetic data in oncology…

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…

PathAI has launched a new digital pathology platform, AISight. Supporting AI-driven research, the digital pathology platform was trained on a real-world dataset of over 5,000 samples with inputs from more than 350,000 cell and tissue-level annotations from more than 50 pathologists. The company has also released its AIM-PD-L1 NSCLC RUO algorithm, which calculates the percentage…

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…

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…

The pharmaceutical industry appears to have addressed a decade-long decline in R&D productivity, according to a recent analysis from Deloitte. In 2021, the projected R&D return on investment (ROI) rose 7%. For comparison, the ROI level in 2010 was 2.7%. Forecast peak sales per asset hit $521 million, up more than 23% over the $422 million…

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 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…