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Clinical Trials

Understand Clinical Trials

Learn about how Clinical Trials work and whether you might be eligible to participate in a study. Through participation in a Clinical Trial, patients may receive a new treatment and support the development of the new medicine.

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How do Clinical Trials work?

Pharmaceutical and biotechnology companies are constantly developing new medicines. They use new technologies and scientific discoveries to try to make safer, more effective medicines.

Every new medicine has to be extensively tested before it is eligible to be approved for public use; it currently takes a significant amount of time for a new medicine to be approved by the regulatory bodies around the world.

It takes on average 15 years for a new medicine, to go from discovery to official approval, and become a registered treatment

Phase I

- Several months
- Test safety, side effects and dosage

Phase II

- Months to 2 years
- Test efficacy and side effects

Phase III

- 1 to 4 years
- Test efficacy and monitoring of side effects

Marketing authorization

If a medicine completes the trials with results which are acceptable, the relevant regulatory bodies (such as the FDA and EMA) grant the medicine marketing authorization, permitting the pharmaceutical or biotechnology company which owns the medicines to make it commercially available to pharmacies and physicians.

Pre-approval medicines

Near the end of Phase II there is usually an indication of the medicine’s safety, tolerability, and efficacy. It is at this point that physicians may feel that there is sufficient evidence for them to justify prescribing the pre-approval medicine through an Early Access Program. This requires patients to be both eligible for the program and unable to participate in a Clinical Trial.

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Clinical Trials & Early Access Programs for your medical condition

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