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Oct21 Before You Blame the Drug: Understanding Variability Safety Lab Values in Early-Phase Trials

Laboratory results represent essential tools for monitoring safety during clinical trial conduct and reassure many investigators as long as they remain within the reference intervals (RIs). These intervals reflect the ‘normal range’ as determined from a set of healthy participants and are usually a...

While the FDA’s Pregnancy and Lactation Labeling Rule (PLLR) introduced a more narrative and evidence-based approach to risk communication, drug labeling in Japan remains largely standardized and continues to rely heavily on preclinical animal reproduction studies. In our study , we found that thi...

Subject information sheets (SIS)/consent documents are not just administrative paperwork, they decisively shape how people enter and experience clinical research. For many participants, the information sheet and consent form are the first detailed explanation of what participating...

Nausea and vomiting in pregnancy (NVP), colloquially known as morning sickness, impacts 8 in 10 pregnancies. When symptoms are severe, patients are often prescribed ondansetron, an anti-nausea medication. Previous studies, in non-pregnant persons, suggest variable response to ondansetron based on ...

Despite growing recognition of clonal hematopoiesis as a confounder in liquid biopsy, the terminology used to describe its biology and clinical implications remains inconsistent. Closely related terms, such as CH, clonal hematopoiesis of indeterminate potential (CHIP), and age-related clonal hemato...

For the neglected tropical skin infection cutaneous leishmaniasis, there is only one approved oral treatment, which is limited by safety and efficacy concerns, underscoring the urgent need for better oral therapies. Drugs for Neglected Diseases initiative (DNDi) has identified DNDI-6148 as a precli...

For decades, researchers have sought ways to control the placebo effect, mostly by educating patients about placebo mechanisms. But what about the study team itself? After all, in early-phase inpatient trials, clinicians, nurses, and coordinators spend days in close, repeated contact with parti...

Pregnant or lactating women with COVID-19 are at increased risk of developing severe disease or complications, such as hypertension, preeclampsia, or a need for intensive care admission. 1,2 However, because of perceived safety concerns regarding infant exposure, breastfeeding women were excluded ...

Neuroblastoma, the deadliest solid childhood cancer outside the brain, is thought to contain two cell states: aggressive, stem-like mesenchymal cells and committed, neuron-like adrenergic cells. Adrenergic cells comprise the bulk of tumors and are generally more sensitive to traditional therapy, wh...

Real-world data (RWD) and real-world evidence (RWE) have the potential to transform how we study the safety, effectiveness, and value of medicines and medical technologies. As researchers, we have opportunities to generate insights from routine clinical care that can complement clinical trials and ...

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