A timeline of the research process

Research is a long process, and it takes time to move from laboratory studies, to clinical trials, to approval and licensing of a drug. It can take years or even decades to develop an idea and turn it into a treatment.

This can be frustrating, but there are good reasons why we rely on clinical research. Find out more on the Sense About Science website.

Clinical trials often start on a small scale. This is because it's important to make sure a treatment is safe in a small number of people before carrying on in a larger number of people.

Once a treatment is considered safe in a small number of people researchers need to look for further evidence that it is safe, as well as effective, on a larger scale. It is vital that findings in small trials are replicated in larger groups of people. 

This is the process:

1. Researcher has an idea for a project and decides how they can test it.

2. Researcher applies for funding. This can come from charities, government research programmes or industry support. Usually this involves peer review – other researchers judging whether the project is of good scientific quality and worth funding. This can take about a year.

3. Researcher needs to get ethical approval from an ethics committee who decide whether the research is safe and respectful. This can take about six months. 

4. Recruit staff to work on the project. This can take six months to a year. 

5. Once staff are in place the project can begin. 

6. Project runs and reports significant results in scientific journals. A project can take three to six years. Sometimes this will generate results that need to continue to be studied in laboratory models in which case it goes back to stage 1.  If it looks like the drug will be effective and there is evidence that it can be developed the project moves on to the next stage.

7. A Phase I clinical trial is a randomised controlled trial involving 15-30 people.

Its purpose:

• to find a safe dosage
• to decide how the treatment should be given
• to observe how the it affects the human body and measure side effects

This can take typically about a year and cost up to £1 million 

8. A Phase II clinical trial is a randomised control trial involving several hundred people

Its purpose:

• to determine if it the treatment a positive effect on MS
• to see how it affects the human body and measure side effects

This can take typically one to three years and cost up to £5 million depending on the nature of the drug/treatment .

9. A Phase III clinical trial is a randomised controlled trial involving hundreds to thousands of people

Its purpose:

• To compare the new treatment with the current standard. This can take typically two to three years and cost up to £50 million depending on the nature of the drug/treatment.

10. Apply for drug license
If clinical trials are successful the researchers apply for a drug licence.

If the drug is deemed safe and effective for people with MS it is granted.

The drug still needs to be deemed cost-effective by the National Institute for Health and Clinical Excellence (NICE) before it is made available on the NHS. This process can take more than a year. 

11. Post Marketing surveillance
It is important that people taking the drug are monitored for a long period of time after the studies are completed.

This ensures that any side effects are documented with more testing and modification if significant side effects occur. This continues for years after a drug is licensed. 

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