Hi, I’m Roy Beran. I’m a Consultant Neurologist and Conjoint Associate Professor at the University of New South Wales, and Professor at the School of Medicine at Griffith University. I joined the Editorial Board of the Virtual Neurology Centre several years ago and today I’d like to share some of my thoughts with you on drug trialling.
Drug trialling means testing new medication in a variety of areas and it depends on the area what is required of the person going into a trial. Usually a drug trial is either to see if the drug works for people who have a disease for which other medicines haven’t yet worked. So there are set criteria for the person to get into the trial. Whatever the disease is, be it epilepsy, multiple sclerosis, whatever, there will be set criteria of inclusion and exclusion and the person has to meet the inclusion criteria to be allowed into the trial, and any of the exclusion criterion will bar them from the study.
Any study that is going to involve human experimentation – and all trials are experimentation – must go through an ethics committee. The committee will determine if the study is a scientifically sound study, it can be performed in the time, the questions asked are real questions, and the patients really are fairly safe or if there is a risk for the patient. The advice given to the patient allows them to understand what is required of them, the risks to which they’re exposed, and then whether they are willing to be part of that trial.
It then follows – it depends on what drug is being tested. For instance, in epilepsy it will be a new drug to be added, usually to those drugs the patient is already on. Because if we know there is effective treatment for disease, we cannot have a placebo control study in which the patient may get nothing. So the patient is given treatment and then on top of that we add the experimental medicine or we may add placebo, which means they’re on the treatment they’re already on and nothing gets added. Or alternatively the experimental medication is added to the treatment they’re already on, so at no time is the patient left without treatment for the condition that they have.
If you want to go into a drug trial then it’s important that you negotiate with the people running the trial to see if you are fit and suitable to go into that study.
|For more information on what are clinical trials, the advantages and disadvantages as well as the different types of trials, see Introduction to Clinical Trials.|