Understanding Clinical Trials

Clinical trials are important to ensure that people receive safe and effective treatments for their health conditions, from heart disease to headaches. They provide the means to develop new treatments that are more effective, safer than treatments already on the market or deliver the therapy via a different mechanism of action; they enable researchers to discover new therapeutic uses for currently available medications; and, they make it possible to develop innovative treatments for conditions that currently have no treatment.

If you have been a participant in a clinical trial before or you have just been invited to participate, the questions below provide some information about clinical trials and what is involved if you agree to participate in a clinical trial.

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FAQS

	About Clinical Trials
	Important information for Participants
	Other Aspects of Clinical Trials

About Clinical Trials
	What is a clinical trial?
	What happens in clinical trials?
	What are the stages in clinical trials?
	What happens with the results?

What happens in clinical trials?

A clinical trial can be designed in a number of ways.

In randomised controlled clinical trials, large numbers of people are recruited to participate in the study. The people who have been recruited are divided by random allocation into two or more groups, so that the groups are similar in terms of age, sex, illness and other factors that could have an impact on the study results. One group is given the medicine being studied; the other group is given a placebo (a tablet which has no active medicine) or a standard treatment for the disease.

You may have read that many clinical trials are ‘double blind’ trials. This means that during the course of the trial none of the participants, clinical trial staff/study staff know who is taking the study medicine or the placebo/standard treatment. This way nobody knows who is taking what until the end of the trial, and so no one can affect the outcome of the trial in any way. The participants are given the study medicine or the placebo/standard treatment to take in the same way as their family doctor would request. At the end of the trial, the results from the people taking the study medicine are recorded and then compared with the results of the people taking the placebo/standard treatment, using statistical measures. This way researchers can get an accurate picture of what people can expect if they begin taking the medicine.

There is a method called “unblinding” which shows the researcher what trial medication the participant is taking should they need to know because of a side effect.

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