Regulatory science
This is the science of developing new tools, standards and approaches to evaluate the efficacy, safety, quality and performance of medical products in order to assess benefit-risk and facilitate a sound and transparent regulatory decision-making.
Clinical trials are essential for testing whether new medicines are safe and effective but it really is just the beginning of the journey.
It must be monitored and regulated for their whole lifetime.
A medicine’s licence is the green light for it to be given to patients and it covers everything about how it should be used, who it's for, and what dose is appropriate.
It then needs to pass strict tests to make sure it's cost effective for the NHS.
Once a medicine is made available, the pharmaceutical company has a duty to continue to monitor it and make sure that performs safely for as long as it's on the market.
This process is called pharmacovigilance and it helps inform regulators about previously unknown side effects, but it can also help to collect additional information, real-world data that can be fed back to improve future research.
More data means a better understanding of what medicine can do often allowing it to be used to treat even more conditions or used in completely different set of patients.
The data can be fed back to progress basic science and unlock treatments for future generations.
Steve Hoare explains how pharmaceutical companies continue to make sure a medicine is safe, and how they use real world data to advance research and discovery.
Clinical trials are very important for finding out if a medicine works and it is safe. Every medicine used in the NHS has to be tested before it can be used.
Clinical trials start with health volunteers and this will be the first time the medicine will be used in people. The next step is then to involve patients with the disease to see if the medicine works: does it delay the disease or cure the disease, and it is safe?
Before anyone gets involved with clinical trials they’ll sit down with the team and work out exactly what’s going to happen, any of the risks and whether a clinical trial is the right thing for them.
As we get more information the trials grow, with more patients in more hospitals not just in the UK but around the world. Trials can take anywhere from weeks to years depending on the type of disease and the type of medicine that we’re studying.
This information is share with the regulator who works out whether to grant a license or not.
New data and technology mean we can do research in new ways, looking into treatments that previously seemed impossible.
The NHS is very active in research with 700,000 people taking part in research for things like cancer, heart disease and diabetes.
Clinical trials are key for how we develop medicines of the future, but we can’t do it without patients and we’re hugely grateful for everyone that makes them happen.
How do we regulate medicines?
Clinical trials are really just the beginning of a medicines journey: they must be monitored and regulated for the rest of their lifetime.
A medicine’s license is the green light for it to be given to patients and it covers everything from what it should be used for, who it should be given to and what dose is appropriate.
The next step is to past strict tests to make sure its cost effective for the NHS.
Once a medicine is made available, the pharmaceutical company has a duty to monitor it and make sure it performs safely for as long as it’s on the market.
This process if called pharmacovigilance and it helps inform regulators about previously unknown side effects – it can also help collected real world data that can be fed back to improve future research.
More data means a better understanding of what a medicine can do – often meaning we can explore using it to treat other conditions or used in other sets of patients.
It may also be fed back to unlock basic science and help progress new treatments for future generations.
Last modified: 20 September 2023
Last reviewed: 20 September 2023