What are Clinical Trials?
Clinical trials are studies carried out to assess the safety and effectiveness of new or existing treatments. They are run according to strict protocols so that they can be used as evidence by the medical authorities in deciding whether or not a new drug should be approved for general use. Smaller-scale research studies are sometimes carried out by doctors or scientists to give them more information about how well different treatments work.
A new drug usually takes 10-15 years to develop before it reaches the market. Only a fraction of the drugs that show initial promise in laboratory studies make it through to approval. By the time a drug is put into trials with patients, it has already passed a series of safety tests on animals and healthy volunteers. Nevertheless, there may be effects that only show up when it is tried in a large number of people.
To be eligible to take part in a trial you must meet certain criteria, which will vary depending on the aims of the study.
You might be interested in trying a new drug but find that you have the wrong type of MS or the wrong symptoms. Of those who do take part in trials, not everyone will receive the treatment in question. Some will act as controls, receiving either a conventional treatment or, more commonly, an inert dummy drug known as a placebo. To prevent bias, neither the doctor nor the patient is told who is getting what. Participants are followed up regularly to assess any changes in their condition and any side-effects. At the end of the trial the data is analysed to see if there are any statistically significant differences between the controls and those who received the treatment. Because MS is an erratic, slow-developing disease, trials often last at least three years.
Clinical trials must conform to ethical guidelines, and you cannot be made to participate in one without your informed consent. If you are asked to take part, make sure you fully understand what the trial will involve and what drugs or other agents will be used. Your doctor should be able to provide you with a written explanation of the project if you want one. You do not have to agree to participate, and you are free to withdraw from the trial at any time. However, many people enjoy the extra medical attention that being in a trial brings, and get satisfaction from knowing that they are helping in MS research.