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.
Clinical trials often start on a small scale. 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 evidence that it is safe, as well as effective, on a larger scale.
This is the general process for drug development:
1. Researcher has an idea for a project and writes a proposal for how it can be tested
2. Researcher applies for funding. This can come from charities, government research programmes or industry. Getting funding usually relies on the research proposal going through peer review.
3. Researcher needs to get approval to do the research from the relevant ethics committee before any participants can be recruited.
4. Recruit staff to work on the project.
5. Once staff are in place the project can begin.
6. Participants are recruited and the project runs and reports results in scientific journals. The length of a research project varies but typically takes between three and six years. Often, more work will need to be done in the laboratory before clinical trials can start. The researcher will then need to go back to the beginning of the timeline to start the process again. 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 typically involves 15-30 people.
- 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 generally takes about a year and cost up to £1 million
8. A Phase II clinical trial typically involves between 100 to several hundred people
- to determine if it the treatment a positive effect on MS
- to see how it affects the human body and measure side effects
This generally takes one to three years and cost up to £5 million depending on the nature of the drug/treatment .
9. A Phase III clinical trial typically involves hundreds to thousands of people
- To compare the new treatment with the current standard. This generally takes 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 then a license to market the drug can be sought.
The relevant regulatory authority (the Medicines and Healthcare products Regulatory Agency in the UK and the European Medicines Agency in Europe) will decide if the benefits of taking a particular drug outweigh the risks.
If the drug is granted a license it still needs to be deemed cost-effective by the National Institute for Health and Clinical Excellence (NICE) or the Scottish Medicines Consortium (SMC) before it is made available on the NHS.
11. Post Marketing surveillance
It is important that people taking the drug are monitored for a long period of time after it is licensed.
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.
Want to find out about the latest MS research? Read Research Matters.