Author: Karen McCusker

As awareness of rare diseases has grown, significant investment has been made to improve the processes and systems to support correct diagnosis and patient care. However, many of these initiatives are focused on a national level, which can create unintentional barriers for clinical research. Rare disease studies require a patient-centric approach and are often designed…

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…

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Romillie Cruz MD, Vice President Medical & Scientific Services, Simbec-Orion The FDA has released a draft guidance last December 2024 on protocol deviations in clinical investigations of drugs, biological products, and medical devices.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…

Our last blog post looked at what is required for a clinical trial unit to achieve an MHRA accreditation, including a commitment to the highest safety standards, comprehensive procedures and processes, and capable, experienced teams. The benefits of an MHRA Phase I accredited site, inspected and approved by regulators, remain the same for a patient…

What is a MHRA Phase I accreditation?If you are considering placing your phase I study in the UK, you may have come across CROs or Phase I Units with an MHRA Phase I accreditation – but what does this mean? The MHRA’s voluntary phase I accreditation scheme is available to organisations conducting phase I trials…

One year after the UK’s biggest overhaul of clinical trial regulation in 20 years, is the UK on its way to becoming a first-class choice for commercial clinical research? Legislative changes to streamline clinical trial approvals were announced by the MHRA in March 2023, promising the biggest overhaul of UK regulation in 20 years to…

Early phase clinical trials are the first stage of testing a new medical treatment, drug, or device in human subjects. The focus of these trials in clinical development is to determine the safety and tolerability of the treatment, as well as to identify any potential side effects. You might also be interested in learning more…