If the results from Phase II are encouraging, we will seek to start a Phase III trial. This will be a much larger trial, often involving hundreds, possibly thousands of participants coming from a range of different countries.
The principle objectives in Phase III are to:
- demonstrate the safety and effectiveness of the potential new medicine or vaccine in the typical patient likely to use it
- confirm effective dosing levels
- identify side effects or reasons why the treatment should not be given to people with the condition in question (known as ‘contraindications’)
- build knowledge of the benefits of the medicine or vaccine and compare them with any risks
- compare results against any currently achieved by existing treatments
To be a success today, a new medicine usually needs to offer the prospect of better treatment for patients than any treatments that are already available.
Phase III trials may last several years. If a new medicine or vaccine completes Phase III with positive results, we may seek regulatory approval to make it available in a range of countries or regions.
In the case of a new medicine, regulators will determine how it should be used, and which patients should qualify for it, based on all the evidence from clinical and pre-clinical studies. This is known as a medicine’s indication.