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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 […]

Romillie Cruz MD, Vice President Medical & Scientific Services, Simbec-Orion The FDA has released a draft guidance last December 2024 on protocol deviations in clinical investigations of drugs, biological products, and medical devices. This document provides essential recommendations for sponsors, investigators, and IRBs to help ensure compliance, data integrity, and patient safety. Key Highlights: What This Means for Simbec-Orion:At Simbec-Orion, we […]

In recent years, the U.S. Food and Drug Administration (FDA) has frequently required sponsors to conduct post-marketing trials after approval. These studies or trials have often been completed to obtain additional information on the optimum dosage of a product where the maximum tolerated dose (MTD) had been used for pivotal trials, in addition to providing […]