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Clinical trials have been a cornerstone of the medical field for decades, serving as a critical foundation for the development and advancement of treatments across a wide range of diseases and health conditions. Beyond establishing the safety and effectiveness of new treatments, clinical trials also play a vital role in exploring ways to enhance care, […]

Clinical trials are essential for advancing treatments for sarcoidosis, especially since no cure currently exists. With the cause of sarcoidosis still unknown, ongoing research remains critical to understanding and combating the disease. Simbec-Orion is a Clinical Research Organisation specialising in rare diseases and oncology, with almost five decades of experience in delivering clinical trial management […]

Clinical trials play a key role in advancing the understanding and treatment of testicular cancer. As one of the most treatable forms of cancer, testicular cancer has a high survival rate when detected early. They offer new explorations into medicines, therapies, and treatment combinations that may improve a patient’s outcome at all stages of the […]

Clinical trials play a crucial role in advancing treatments for Parkinson’s disease, especially as there is still no cure and much about the disease remains unknown. As the fastest-growing neurological condition worldwide, Parkinson’s will impact approximately 1 in 37 people in the UK over their lifetime, making continued research essential. With nearly five decades of […]

In 2021, Project Optimus was launched by the U.S. Food and Drug Administration’s (FDA) Oncology Center of Excellence (OCE) to help oncology drug developers target dose optimisation and guide selection processes. Here, we answer some of the most pressing questions developers may have about the initiative. 1. What is the aim of Project Optimus? The […]

Promoting greater inclusivity among clinical trial participants plays a pivotal role in addressing healthcare inequalities and fostering equal access to healthcare. To further our understanding of treatments and vaccines, it’s crucial that those taking part in trials mirror the disease’s prevalence in various demographics and accurately represent relevant clinical populations.  Increasing clinical trial diversity and […]

Project Optimus, an initiative introduced by the U.S. Food and Drug Administration’s (FDA) Oncology Center of Excellence (OCE) in 2021, has an overarching goal of shifting the paradigm of dose selection in oncology drug development [1]. It aims to move away from the traditional focus on the maximum tolerated dose (MTD) to selecting doses that […]