Are Clinical Trials Right For You?
‘Clinical trials’ is a term often heard mentioned when someone is diagnosed with a critical illness. But what exactly are clinical trials? What is involved? Will the treatment actually help you or could it make you worse? This article aims to explain what to expect if you are approached and asked to participate in a clinical trial.
What are clinical trials?
Many areas of medicine run trials. They are one of the ways in which new drugs are tested and knowledge advances. There are three clinical stages through which a drug, or other form of treatment, must pass before it is made widely available as a recognised and accepted treatment.
Before a drug even reaches the trial stage, it will have undergone many years of development under strict laboratory conditions. When the results of that research work indicate that there is in theory a benefit to using that drug in patients, a trial will be commissioned.
Phase I trials
Phase I of a clinical trial is the first time that a drug has been given to humans. This part of the trial is largely devised as a study of what side effects may occur and how well the drug is tolerated. Most drugs will have been shown to be safe and well-tolerated during studies using animals and the trial will begin at a very low dosage. Once satisfactory results have been achieved, the dose is increased until the optimal balance between side effects and dosage is reached.
At this early stage in the trial, there is no concrete evidence that the trial is any better, the same or worse than the standard treatments already in use.
Phase II trials
Phase II trials examine how effective a cancer drug is at actually reducing a tumour in size although it does not carry out comparisons to assess effectiveness against the current standard treatments.
These trials are also useful in providing additional information regarding tolerance and side-effects. The end aim is to assess the participants’ ‘response rate’ and to provide additional information which ensures that the following Phase III trial is designed to include sufficient numbers of participants to give an indication as to whether the new drug is an improvement on the current standard.
Phase III trials
Phase III trials are the most important but are also the most tricky to run. A large number of participants are usually required and often many specialist units are involved which can include international collaboration.
Treatment is allocated randomly between the best current treatment, to the new drug under trial or to a combination of drugs. At this stage of the trial there is still no clear evidence that the new drug is any better, equal to or worse than the existing treatment. There may still be benefits through improved disease control and fewer side effects.
When the trial is concluded, all the results are collated and analysed before a conclusion is drawn as to whether there is a real benefit in a change to what is considered to be the best proven treatment or not.
Clinical trials are safe and very closely regulated and monitored. They are the only way in which specialists can introduce new and improved drugs into the marketplace and they rely on patients’ participation for their success.
If you have any questions about upcoming clinical trials which are pertinent to your own condition, ask your specialist nurse or oncologist. They will be able to tell you whether there are any trials coming up in your specialist centre and if you would be suitable to take part.
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About Alison Page
Alison is a small business owner, freelance writer, author and dressage judge. She has degrees in Equine Science and Business Studies. Read her full story at http://www.theladywriter.co.uk