What Are Clinical Trials?
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A Clinical trial is a procedure in medical research that is used to measure the efficacy and safety of a new drug or treatment. Clinical trials can only take place in humans after certain safety criteria have been met. This will usually mean extensive laboratory investigation and testing on cell growth and in animals. The tests that are undertaken before a clinical trial is permitted with humans is called a pre-clinical trial. It is a common misconception that trials deal only with the development of new drugs. Whilst the many trials are centred on new drug development, a clinical trial can also be conducted to test existing treatments, medical devices, surgical or physical procedures and other therapies.
Process
An early clinical trial usually consist of a small pilot group that takes a mixture of healthy volunteers and patients who are treated with the new drug or procedure. If the pilot progresses successfully, the study is expanded to larger groups. As long as the new drug or procedure shows improved efficacy and acceptable safety levels the number of participants in the trial will increase. This means that a trial might have as few as ten participants or many thousands depending on what phase it is at.
Trials are divided into 4 phases. Passing phases 1-3 are necessary in order for a drug or procedure to get approval and become licenced by the relevant health authority. Phase IV trials are conducted after the drug or procedure has been approved and usually focuses on side effects and long-term risks and benefits.
Phase I
These are the earliest trials for a new drug or treatment. After laboratory tests have been complete, phase I trials are conducted to calculate the safe dose range, examine side effects, look to see if the treatment has an effect (in breast cancer that would be shrinking the tumour) and see how the body copes with the drug. With cancer drugs, phase I trials usually are run as dose escalation studies. The first group of patients receive a small dose of the drug and, if all goes well, the next group get a slightly higher dose. With each group the dose is slowly increased and the effects noted.
Patients taking part in a phase I trial, have lots of blood tests, as the researchers look at how the drug is affecting them. They also examine how the body copes with, and gets rid of the drug.
Phase II
Not all drugs or treatments tested in a phase I trial successfully make it through to phase II. Phase II trials aim to find out if the new treatment works well enough to test in a larger phase III trial, which types of cancer the treatment works on, more about side effects and how to manage them, and more about the best dose to use. Sometimes in a phase II trial, a new treatment is compared with an existing treatment, or with a placebo. If the results of phase II trials are positive and its performance matches or exceeds that of existing treatments, it then moves into phase III.
Phase III
Phase III trials compare the new drug or treatment against existing available treatments. This phase compares different dosing methods, or ways of administering the treatment, new ways of administering existing treatments and new drug efficacy against an existing drug. Phase III trials can involve large numbers of patients. This increased number allows researchers to discover anomalies and more easily recognise trends in the data they collect.
Phase IV
Phase IV trials typically look at drugs after they have been granted approval and are in public use. These trials often look at the long-term side effects, safety and efficacy of a drug or treatment.
Benefits
The benefits of a clinical trial are that in advanced breast cancer cases, new drugs might prove effective where existing drugs have not. For patients who have not responded well to other drugs, clinical trials offer hope. The main benefit of trials is the advancement of research into the development of future drugs.
10637 Published April 2012
Review Scheduled April 2013
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