The types of new treatment tested in clinical trials can include drugs, surgery procedures or therapy. However, by and large, if you’re involved in a clinical trial it will be the testing of a new drug. Clinical trials are needed because introducing a new treatment without rigorous and conclusive testing goes against current legislation, as well as the ethics of the medical profession and the scientific method.
Clinical trials needed to be carried out on humans in order to establish safe dosages and determine whether or not the treatment causes any side effects. To ensure that any side effects that do materialise are manageable and controlled, clinical trials adopt Bayesian methodology, and initially administer a very small dosage, which is gradually increased throughout the trial, the volunteer is closely monitored throughout the process.
Before medical professionals will even consider the approval of a human based clinical trial each treatment is subjected to laboratory testing on stem cells. This period can take months and is known as the pre-clinical trials, where institutes or drug companies study how a new treatment works and what sort of side effects and symptoms may occur as a result.
Once pre-clinical trials are completed and the outcome is positive, approval for trials on humans is then sought from the highest medical regulatory authority. The company proposing the trials must draw a plan that includes all the details of the trial; what it seeks to prove, which treatments will be compared, how this is carried out and finally, how results will be collected. With everything considered, if it is deemed safe, a clinical trial is then approved.
Trials will then last from anywhere between 1 and 30 days. Before a volunteer can be accepted onto the trial, they must pass an initial “screening visit” to ensure that they are healthy and it is safe for them to participate. Different demographics will be required for different trials depending on what treatment is being tested. Again this is to ensure that tests are controlled and variables are isolated. In some cases it can take years for new treatments to go through all of these stages which reflects on the sound safety procedures that all clinical trials are controlled by.
Hopefully you now understand why new treatments are subjected to clinical trials and know a little bit about the methodology that ensures this process is as safe as possible. Clinical trials are much like any other activity such as cycling or crossing the road in that a theoretical risk is involved, but advances in medical technology and stringent controls ensure that these risks are minimised.
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This article was written by Nick Davison for Covance Medical Trials Leeds.