| What is Clinical Research |
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Clinical Research – A Sunrise Industry
Though many people read about clinical trials, not all know exactly what they are or who participates in them.
Clinical trials are actually research studies to answer specific questions about new therapies or new ways of using known treatments.
Clinical trials are used to make sure new medicines or treatments are both safe and effective. Carefully conducted clinical trials are the fastest and safest way to find treatments that work in people. Today, they take place in a variety of locations such as hospitals, universities, doctors' offices or community clinics.
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Clinical Research is conducted in 4 Phases.
Phase 1 (phase I)
These are the earliest trials in the life of a new drug or treatment. They are usually small trials, recruiting anything up to about 30 patients, although often a lot less.
When laboratory testing shows a new treatment might help treat cancer, phase 1 trials are done to find out
• The safe dose range
• The side effects
• How the body copes with the drug
• If the treatment shrinks cancer
The researchers will monitor the effect, until they find the best dose to give. This is called a 'dose escallation study'.
Phase 2 trials (phase II)
Phase 2 trials are done to find out
• If the new treatment works well enough to test in a larger phase 3 trial
• Which types of cancer the treatment works for
• More about side effects and how to manage them
• More about the best dose to us
Although these treatments have been tested at phase 1, you may still have side effects that the doctors don't know about. Drugs can affect people in different ways.
Phase 2 trials are often larger than phase 1. There may be up to 50 or so people taking part. If the results of phase 2 trials show that a new treatment may be as good as existing treatment, or better, it then moves to phase 3.
Phase 3 (phase III)
These trials compare new treatments with the best currently available treatment (the standard treatment). They may compare
• A completely new treatment with the standard treatment
• Different doses or ways of giving a standard treatment
• A new radiotherapy schedule with the standard one
Sometimes
phase 3 trials involve thousands of patients in many different hospitals and even different countries.
Phase 4 (phase IV)
Phase 4 trials are done after a drug has been shown to work and has been granted a license. So they are looking at drugs that are already available for doctors to prescribe, rather than new drugs that are still being developed.
The main reasons pharmaceutical companies run phase 4 trials are to find out
• More about the side effects and safety of the drug
• What the long term risks and benefits are
• How well the drug works when it’s used more widely than in clinical trials.
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