Research Process

It takes a very long time to get a new medicine ready to be sold in shops and used in hospitals. It all begins with a man or a woman thinking that they would like to make a new medicine. Then they talk to their friends about the medicine. They talk about how it will work and if it will be safe to try it. Some time later, they make a little of the medicine and they ask a few people to try it. If it seems alright, they make more of it and they ask more people to try it. They do this a few times, each time asking more and more people to try it. When they are sure it will work and it will be safe, then it can be sold in shops and used in hospitals.

 


When we say ‘research process’ we mean people are trying a medicine to find out how it will work and if it will be safe. We say there are four ‘phases’ as more and more people try it.



Phase 1

 

In phase 1, only a few grown-ups try the medicine. No-one has tried the medicine before, so children are not allowed to try it. The grown-ups might not even be poorly! In phase 1, we find out how much it is safe to take. We also find out what happens to the medicine when it is inside the grown-ups.

 

Phase 2

 

In phase 2, both children and grown-ups can take part. The people who take part may be poorly – if we think the new medicine will make them better. In phase 2, we find out how much medicine poorly people need to take to get better. We find out how the medicine works and how safe it is. We find out if the new medicine is better than other medicines.

 

Phase 3

 

Phase 3 is like phase 2, but more people take part. This way, we can learn a lot more about the new medicine. At any phase, we might decide the medicine is not as good as we hoped, so we might stop trying it. Or, we might decide it is good for some people, but not as good for other people. At the end of phase 3, the new medicine might be sold in shops and used in hospitals if it is alright.

 

Phase 4

 

In phase 4, the medicine is not really new – it is already sold in shops or used in hospitals. In phase 4, a lot more poorly people try the medicine. We learn a lot more about the medicine. If someone is very poorly with different things, the medicine might make them feel better in one way and worse in another way. If someone is taking more than one medicine, the medicines might not work together.

The Trent Local Children’s Research Network operates as part of the NIHR Medicines for Children Research Network in England. It is part of the National Institute for Health Research and forms part of the UK Clinical Research Network. The Networks support and deliver high quality clinical research studies.
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