What are Clinical Trials?
Clinical trials are research studies that aim to establish whether a medical treatment or device is safe for use by humans. Some studies may also assess how effective a particular medical method is for specific groups of patients or conditions. In general, their intention is to enhance current medical knowledge about the treatment, diagnosis and prevention of conditions or diseases by collecting valuable and reliable data to influence public health guidelines and improve the lives of patients worldwide. Clinical trials are usually initially conducted in small groups of healthy volunteers to see whether a new drug or device causes side effects not already seen in animal models or during laboratory testing.
The data collected during a clinical trial not only provides information about how a new drug or device works but can also provide important information about how a treatment improves quality of life, its cost-effectiveness and the potential added clinical value of a diagnostic test.
While all clinical trials have a basis in research, they can take different forms depending on the type of information and data needed. Some trials are designed to test a new treatment or therapy which may include new combinations of drugs designed to work more effectively together or discovering new ways of diagnosing and preventing diseases. It’s not always about testing a new drug, as other trials look at testing the best way to screen specific conditions and diseases or evaluating how a particular healthcare process is managed and organised.
In order for a clinical trial to produce valuable and beneficial data, many areas need to be considered carefully. A well-planned study will consider the number of participants needed, the eligibility criteria and how the data is going to be collected. It is important that the safety and well-being of participants is protected so the types and number of tests that will be performed need to be appropriate and not burdensome.
Another consideration during the planning stage is addressing the possibility of bias. The definition of bias in the Cambridge Dictionary is ‘the action of supporting or opposing a particular person or thing in an unfair way, because of allowing personal opinions to influence your judgment’. In terms of a clinical trial, bias refers to an individual’s choices or other influences that which may affect the results of the trial. To counteract the possibility of bias, researchers use different strategies.
Most clinical trials compare treatments by randomly dividing participants into comparison groups. By doing this the researchers are looking for the collected data to show that one treatment regime shows better outcomes than the other. Many trials will look at comparing an existing, standard of care treatment with the new treatment, or comparing a new treatment to a placebo group where the participants receive an inactive intervention which looks just like the real treatment. By randomly assigning participants to the comparison groups also eliminates any bias that could introduced by participants or researchers choosing which group they are allocated to.
One of the common strategies used is known as blinding or masking and is used in trials that are comparing different treatments. This means that either the trial participants or the researchers conducting the trial are not aware of which treatment the participants will be receiving. If a study is described as ‘single blinded’, this means that either the participants or the researchers are not aware of which treatment group they are in. If a study is ‘double blinded’ neither the participants or the researchers are party to the treatment being taken.
Stay tuned for more articles covering the basics of clinical trials, written by industry experts at the Clinical Professionals Group.
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