There are many effective drugs, treatments, surgeries and procedures. This is as a result of research and clinical trials. Before any drug or surgery makes it to market it goes through a series of clinical trials. In this section you will learn about clinical trials and how you can participate in one.

What is a Clinical Trial?

A clinical trial is a research study conducted with patients who have been diagnosed with major illness and generally involves testing of new treatments or finding ways of improving existing treatments. Clinical trials are conducted all over the world in most large hospitals in an attempt to improve treatment for many diseases.

The main objective of a clinical trial is to compare two or more groups of subjects, using two or more treatment options to determine the effectiveness of a proposed drug or biological treatment.

Clinical trials are carefully and ethically designed to allow truthful and precise collection and analysis of information to find out more about a disease. Such trials help discover whether a promising new treatment is safe and effective, as well as giving a better understanding of the current standard treatment, in the hope of improving the side effects experienced by many patients.

Types of Trials

Clinical trials are conducted in four phases before they can be considered for registration and use.

Phase I trials involve a small number of patients and are designed to test the safety and dosage of a new drug and to evaluate side effects of various dosage levels.

Phase II trials involve larger numbers of patients and test the effectiveness of a treatment given in a particular dose.

Phase III trials are full-scale controlled examinations of new drugs or treatments and are designed to more fully explore the potential benefits and risks of the treatment under study. Often, the standard or current treatment is compared to a newer and potentially better treatment. This trial is a randomised trial, meaning the treatment is chosen at random- neither the patient nor the doctor can decide which treatment the patient will receive. This ensures an equal number of patients are allocated to each treatment and removes any bias the doctor or patient may have to one treatment or another.

Phase IV trials allow pharmaceutical companies to monitor any adverse side effects on a larger scale than Phase III studies and help clarify other uses for the drugs, for example, treatment of another disease.

Why should I enter a Clinical Trial?

Patients take part in clinical trials for many reasons, usually with the hope of direct treatment benefits for themselves. This might include a greater chance of a cure, a longer time to live or better quality of life. Sometimes patients want to contribute to research that will help future sufferers of the disease.

Patients who participate in clinical trials, in which improved results are seen, have the first chance to benefit from these improved treatments.

How do I participate in a Clinical Trial?

Before you consent to participate in a clinical trial, you will be given an information sheet, which contains all the information about the trial, including the risks and benefits. With any form of treatment being assessed in a clinical trial, side effects can be experienced and this is always balanced against the benefits of treatment. You will also be given the opportunity to discuss the trial with your treating doctor, who will be able to answer any questions.

If you agree to participate you will be asked to sign a consent form, stating that you have read and understood the purpose of the trial and the risks and benefits attached to it. You are free to withdraw from the trial at any time. All the ethical and legal codes that apply to medical practice are carefully followed in clinical trials.