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 are the stages in clinical trials?

There are various stages or phases involved in the journey of the development of a new medicine, from the laboratory until the local pharmacy where it is available to consumers.

Initial Testing: Following the initial development of the medicine, which can take several years, it is extensively tested in the laboratory and on animals to work out its actions, to determine what the side effects might be, and to make sure it is not harmful.

After the initial development and testing, clinical testing begins and this requires Ministry of Health approval and Ethics Committee review. Clinical trials are divided into three phases of study, each phase involving greater numbers of people.

Phase I: Here the focus is mostly on the safety of the medicine. Studies are normally conducted on healthy volunteers, usually numbering between 20 to 100 people. Researchers study the effective and tolerated dose and how the medicine is absorbed, broken down and eliminated by the body, as well as identifying any side effects at different doses. This phase generally lasts several months. Usually about two-thirds of medicines progress past phase 1.

Phase II: Here the focus is on the effectiveness of the study medicine in treating the intended disease. In this phase there is also some emphasis on side effects and risks in participants with existing health problems. Generally, a few hundred patients participate in phase II trials, which take longer than phase I trials. Only about one third of medicines successfully complete this phase.

Phase III: In this phase the focus is on safety, effectiveness and determining the right dose to treat the disease. Several hundred people with the disease in question may participate. By using such large numbers of people, less common side effects will emerge. Of the medicines that complete phase II, most of these successfully complete phase III.

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