Kresnier Perez

Human challenge trials, also known as controlled human infection studies, represent a unique and increasingly relevant approach in the field of medical research, particularly in vaccine development. In these trials, healthy volunteers are intentionally exposed to a pathogen to study the effects of an intervention, such as a vaccine or therapeutic treatment. This method allows […]

Decentralized clinical trials (DCTs) have emerged as a transformative approach in the realm of medical research, particularly in the wake of the COVID-19 pandemic, which necessitated innovative methodologies to ensure continuity in clinical investigations. DCTs leverage technology to facilitate remote participation, allowing patients to engage in trials from the comfort of their homes. This model

A clinical hold is a regulatory action taken by health authorities, such as the U.S. Food and Drug Administration (FDA), to pause or suspend a clinical trial. This action is typically initiated when there are significant concerns regarding the safety of participants, the integrity of the data being collected, or the overall scientific validity of

Neurobehavioral research is an interdisciplinary field that merges neuroscience, psychology, and behavioral science to understand the complex interplay between brain function and behavior. This area of study seeks to unravel the mechanisms underlying various neurobehavioral disorders, such as autism spectrum disorder, attention-deficit/hyperactivity disorder (ADHD), and schizophrenia. By examining how neurological processes influence behavior, researchers aim

The United Kingdom Prospective Diabetes Study (UKPDS) is a landmark clinical trial that has significantly shaped the understanding and management of type 2 diabetes mellitus. Launched in 1977 and concluding in 1997, the UKPDS aimed to investigate the impact of various treatment strategies on the long-term health outcomes of patients with newly diagnosed type 2

Protocol design is a critical component in the realm of clinical research, serving as the blueprint for how a study will be conducted. It encompasses a comprehensive plan that outlines the objectives, methodology, and operational aspects of a clinical trial. The protocol not only guides researchers in executing the study but also ensures that the

The design of a clinical trial protocol is a foundational element that dictates the study’s integrity, feasibility, and overall success. A well-structured protocol serves as a roadmap for the entire research process, detailing the objectives, methodology, and operational procedures necessary to achieve the desired outcomes. It is not merely a bureaucratic requirement; rather, it is

Optimizing clinical trial protocols is a critical step in the drug development process, as it directly influences the efficiency, cost-effectiveness, and overall success of clinical trials. A well-structured protocol serves as a blueprint for the entire study, detailing the objectives, design, methodology, statistical considerations, and operational aspects. The significance of optimizing these protocols cannot be

Donanemab is a monoclonal antibody designed to target amyloid-beta plaques in the brain, a hallmark of Alzheimer’s disease. Developed by Eli Lilly and Company, this investigational drug represents a significant advancement in the ongoing battle against neurodegenerative disorders. The emergence of donanemab is particularly noteworthy as it aligns with a growing body of research that

Translational study, often referred to as translational research, serves as a bridge between laboratory discoveries and clinical applications. This field of research is pivotal in transforming scientific findings into practical treatments that can significantly improve patient care. The essence of translational research lies in its ability to take insights gained from basic science and apply