The Path to Progress: Clinical Trials Spotlight
After Research and Development, the next stage of The Path to Progress journey is Clinical Trials.
Following the drug development process, any new investigational treatment must undergo rigorous clinical testing before it is made available – this activity is known as clinical trials.
Clinical trials are studies conducted in humans that evaluate the safety, efficacy, and tolerability of a new medicine, and are a key part of bringing new medicines to patients. They are split into four phases, each of which is intended to ensure a medicine is effective and tolerable within a given patient population.
Researchers test a medicine in a small group of people to evaluate a dosage range and identify any potential adverse events.
The medicine is tested in a larger group of patients and at different doses, to further monitor for adverse events.
The next step involves trials conducted in a much larger population of patients, in different regions around the world.
Phase 3 trial results will often form the basis of a country licencing approval, such as approval from the Medicines and Healthcare products Regulatory Agency (MHRA) in the UK and the Health Products Regulatory Authority (HPRA) in Ireland.
Finally, a Phase IV clinical trial may take place to test an approved medicine in a real-world setting. This takes place over a longer period, to learn more about the drug and identify any rare adverse events.
Bristol Myers Squibb clinical trials in the UK & Ireland
Our clinical trials often begin at the company’s UK Head Office, located in Uxbridge. Here, the clinical operations team manage all the intricate processes associated with getting clinical trials set-up, monitored, and completed.
Michelle Szabo, Head of Clinical Operations, Paulina Sirko-Nowak, Senior Clinical Trial Manager, and Sem Abdulle, Senior Clinical Trial Monitor, are part of our UK & Ireland clinical operations team. They collaborate to faciliate the clinical trial process, all with the aim of bringing innovative treatment options to patients.
Watch the Clinical Trials Spotlight video below to learn more.