What is a Clinical Trial?
A clinical trial is a research study conducted with patients who have been diagnosed with a cancer or other major illnesses 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.
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.
Who can volunteer?
Each study has pre-stated study requirements that must be fulfilled. Some studies require volunteers with good health while other studies require volunteers with certain disease conditions e.g. Benign Prostatic Hyperplasia, Prostatic cancer, etc.
What are adverse events?
Any unfavourable and unintended sign, symptoms or disease temporarily associated with the use of medicinal product. It may or may not necessarily be related to the treatment given.
Every medicine has the potential to cause adverse effects. We cannot determine who may develop adverse effects, or which adverse effects they may be. Volunteers will be informed of the potential side effects gathered from previous studies before they agree to participate. During the study, volunteers should inform their doctor or research nurse about any side effects they think they might be experiencing. This will form part of the important information collected during a clinical trial.
Expenses for treatment of adverse effects are covered by trial insurance, which is provided by the trial sponsor.