Clinical Trial
•	A clinical drug trial is a carefully controlled study in which patients take a drug to find out whether it is safe and effective and the optimal dosage.
•	In a clinical trial, one or more different drugs or combinations of drugs are compared to each other. A clinical trial often gives one group of patients an experimental drug, while the other group gets a placebo

Who can join a clinical drug trial?
•	 Each clinical drug trial has strict guidelines and criteria to help in the selection of candidates for each study, e.g. age, previous and recent medical and psychiatric histories, prior and concomitant treatments, and pregnancy.
•	The criteria differs from study to study and enrolling into a study is voluntary

Reasons to join a clinical trial or not
•	Deciding to join a trial can be difficult. There are always risks involved taking any medication. Carefully weigh the risks and benefits of a trial you are considering to join.

Reasons to join a trial
•	the treatment being tested may work for you
•	clinical drug trials may be the only way to gain access to a promising new drug
•	drugs that are given in a trial are free
•	you can help speed the development of new treatment
•	your contributions of information, while in a clinical drug trial may benefit others
•	you will be one of a small percentage of the population to receive this treatment

Reasons not to join a trial
•	you may have to stop taking your current medication that works for you
•	your condition may get worse
•	the treatment in the trial may have unexpected side-effects
•	you don’t have the energy, time or interest to participate in a trial

What is informed consent?
•	Informed consent is a document designed to inform you of the purpose and design of a study, its possible side-effects and benefits and what your other options may be. It is required by the Food and Drug Administration in America, the Medical Control Council of South Africa, as well as the Ethics Committee of your local drug trial unit. The consent form is not a contract. You can leave the trial at any time, without giving a reason.

What do I need to know or do before joining a clinical trial?
•	Every trial is different, so it is important to familiarise yourself with all the aspects of the study, before joining it. Everything regarding the study should be explained to you by the Doctor or Specialist (Investigator) conducting the study. You must get the opportunity to ask questions and should be provided with understandable explanations before signing any consent form.

What about my medical needs while participating in a trial?
•	While you are participating in a clinical drug trial the investigator of the study will do regular physical examinations, special investigations and laboratory tests. If he or she is concerned about anything they will refer you to a specialist or a general practitioner to investigate your problem. If this problem occurred while you’re in the study and the investigator feels it may be drug related, the sponsoring company may be responsible for any costs.
•	When joining a study your investigator should inform your general practitioner or specialist about the study.

Rights of a patient
•	To be informed of the nature and purpose of the study.
•	To be told what will happen and whether any of the procedures, drugs or devices are different from what would be used in standard practice.
•	To be told of the discomforts and / or the risks that can be expected from the study.
•	To be told of the benefits to expect while participating.
•	To be offered other options apart from participating in the study, the benefits and risks of alternative options should be explained.
•	To be allowed to ask any questions concerning the study before entering, while in the study and after completion.
•	To be informed what concomitant treatment is available to treat any side-effects.
•	To be able to refuse to participate at all or to stop participating after the study started and that this decision will not effect rights to receive medical care outside the clinical trial.
•	To receive a copy of the informed consent.
•	To be under no obligation or pressure while deciding, before agreement to participate in a trial.