TRIALS
Four phases
The NHS says all clinical trials of new medicines go through a series of phases to test whether they are safe and whether they work.
Walk the phasesHOW MEDICINES ARE CHECKED
From lab bench
to licence.
Before a new medicine reaches a pharmacy shelf, it has to prove it is safe and that it works.
Walk the trial phases
4 PHASESof clinical trials
That happens in stages: phased clinical trials, a licence from the regulator, and safety monitoring that carries on for as long as the medicine is used. This independent guide explains the process from NHS and MHRA sources. It is general information, not medical advice.
At a glance
- Test in stages
- Licence before use
- Keep watching after
- Safety checked before and after
750,000+
Yellow Cards received, 1964 to 2014
The MHRA said in 2014 that over 750,000 Yellow Cards had been received since the scheme began in 1964.
YELLOW CARD · MHRA 2014
≈ 25,000
Side-effect reports a year
Around 25,000 reports of suspected adverse drug reactions were arriving each year, about 7% of them directly from patients.
YELLOW CARD · MHRA 2014
TWO NUMBERS WORTH KNOWING
Fifty years,
thousands of reports.
Two figures from the Yellow Card scheme's
50th anniversary in 2014.
Patients have been able to report directly since 2005. Reports are of suspected reactions, and the MHRA uses them alongside other scientific safety information before deciding whether to act.
THE TRIAL PHASES
How many people
test a new medicine?
Pick a phase to see what happens in it, according to the NHS. The bar shows how many people are usually involved.
Based on the NHS page on clinical trials. General information only; it is not advice about any medicine.
THE SHORT ANSWER
Tested in phases,
watched for life.
No new medicine skips the checks.
Three stages worth knowing.
THE REGULATOR
The MHRA decides
Before a trial of a new medicine can begin, the MHRA must review and authorise it, and it inspects trial sites for good clinical practice.
What the MHRA does
AFTERWARDS
The Yellow Card
Since 1964 the Yellow Card scheme has collected reports of suspected side effects. Anyone can report a problem with a medicine.
How it works
THE YELLOW CARD SCHEME
Spot it,
report it.
The scheme is run by the MHRA and open to everyone. These points come from the Yellow Card site and MHRA announcements.
Read the leaflet
The MHRA says to always read the patient information leaflet or instructions that come with a medicine. It lists known side effects and what to do.
Worried? Ask a professional
If you are worried about your health, speak to your doctor or pharmacist, or call NHS 111. The Yellow Card scheme cannot give medical advice.
Report a suspected side effect
Anyone can report an issue with a medicine, vaccine, medical device, blood product or e-cigarette, online or through the Yellow Card app.
Reports change warnings
Yellow Cards help the MHRA spot new safety issues early and, if needed, change the warnings or the way a medicine is used.
WHAT THE MHRA DOES
One regulator,
the whole lifecycle.
The Medicines and Healthcare products Regulatory Agency regulates medicines, medical devices and blood components for transfusion in the UK. Its job is to make sure they meet standards of safety, quality and effectiveness, and that the supply chain is safe.
The NHS says a licence means a medicine is available on prescription. The MHRA's remit also covers vaccines, e-cigarettes and traditional herbal and homeopathic remedies, and it educates the public and professionals about risks and benefits.
Questions
Questions people ask
Who approves medicines in the UK?
The Medicines and Healthcare products Regulatory Agency (MHRA). It regulates medicines, medical devices and blood components, and must authorise a clinical trial of a new medicine before it can begin.
What are the phases of a clinical trial?
The NHS describes four: a small first-in-human group (phase 1), a larger group of patients (phase 2), large comparisons with existing treatments or placebo (phase 3), and monitoring after licensing (phase 4).
What is a placebo?
A dummy treatment. The NHS says new medicines are usually tested against a control, which is either a placebo or a standard treatment already in use.
What is the Yellow Card scheme?
The UK's system for collecting suspected side effects and other problems with medicines and medical products. It was set up in 1964, after the thalidomide disaster, and is run by the MHRA.
Can I find a clinical trial to join?
The NHS points to the Be Part of Research website, which lists UK studies, and suggests asking your doctor or a patient charity. You can leave a trial at any point without it affecting your care.
Sources
Where the facts come from
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