FAQ

•  What are clinical studies?
•  What is a protocol?
•  What is a informed consent document?
•  How safe is it?
•  Why participate in a clinical trial?
•  Are there risks involved in participating in clinical research?
•  What are your rights if you take part in a clinical trial?

 

What are clinical studies?

Clinical studies are research studies in which real people participate as volunteers. Clinical research studies (sometimes called trials or protocols) are a means of developing new treatments and medications for diseases and conditions. New medications are first studied in laboratories and in animals to obtain information that may predict efficacy and safety in humans.
Clinical studies in humans follow a step wise approach. The phases of development  fall into one of four categories: Phase I, II, III and IV..
Phase I: Researchers test a new medicine in a small group  healthy volunteers, for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase II: The medicine  is given to a larger group of people suffering from disease to see if it is effective and to further evaluate its safety.
Phase III: The medicine is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely. Phase III clinical trials focus on a particular disease and ask specific scientific questions which have the long-term goal of defining the best approach to therapy by comparing one therapy to another. 
Phase IV: A registered treatment is given to large groups of people with a particular disease over  long  period of time  to monitor  effectiveness and  side effects, compare it to commonly used treatments, and collect information that will allow long term safe use of the treatment.

What is a protocol?

All clinical trials must be conducted according to strict scientific and ethical principles. Every clinical trial must have a protocol, or action plan that describes what will be done in the study, how it will be conducted, and why each part of the study is necessary - including details such as the criteria for patient participation, the schedule of tests, procedures, and medications, and the length of the study.
The protocol also explains what the trial hopes to accomplish, how the trial will be carried out, and why each part of the trial is necessary.
Protocols are written by the trial sponsors (those conducting the trial) and must first be reviewed by an Institutional Review Board (IRB) at each participating hospital or medical center before they can begin. IRBs are committees that oversee the safety of people who take part in clinical trials.

What is an informed consent document?

A document that describes the rights of the study participants, and includes details about the study, such as its purpose, duration, required procedures, and key contacts. Risks and potential benefits are explained in the informed consent document. The participant then decides whether or not to sign the document. Informed consent is not a contract, and the participant may withdraw from the trial at any time.

 How safe is it?

Clinical trials are carried out under the strict supervision of fully qualified doctors, nurses and other health professionals. Two government bodies must first approve all trials before any clinical procedures may commence. The two government bodies are the MMC (Medicine Control Council) and a government authorized Research Ethics Committee. In order to give approval for the study to go ahead the MCC experts will assess all applications for new medicines to ensure that they meet the required standards, and the Research Ethics Committee have specially trained members in research ethics and often have the sort of experience which will be useful in scrutinizing the ethical aspects of a research proposal.
Before entering into a trial, volunteers are given complete written information about the study to read through. One of the Research Doctors then discusses all the details and potential risks of the study. This process is called informed consent and will be completed before any study procedures are able to take place. After the formal consenting session with the doctor you will be able to take the information home to discuss with friends, family and maybe even your GP. You do not have to sign the informed consent document, unless you want to take part in the study. And even after you have signed the document, you are allowed to withdraw from the study at any time. 
Volunteers are very carefully screened and are required to undergo a thorough medical examination, which includes taking blood samples for a variety of tests (including Hepatitis and HIV) as well as tracing your heart (ECG) and measuring your blood pressure. With your consent, we might also contact your GP to check that there are no medical conditions in your history that might affect your participation. After going through the screening medical examinations, the Research Doctor can now make a decision, using the approved study protocol, if you can be selected to enter into the study.

Why participate in a clinical trial?

The health of millions has been improved because of advances in science and technology, and the willingness of thousands of individuals like you to take part in clinical research. Participants in clinical trials can play a more active role in their own health care, gain access to new research treatments before they are widely available, and help others by contributing to medical research.

Are there risks involved in participating in clinical research?

The specific risks associated with any research protocol are described in detail in the consent document, which you are asked to sign before taking part in research. In addition, the major risks of participating in a study will be explained to you by a member of the research team, who will answer your questions about the study. Before deciding to participate, you should carefully weigh these risks. Although you may not receive any direct benefit as a result of participating in research, the knowledge developed may help others.

What are your rights if you take part in a clinical trial?

Taking part in a study is voluntary. You may choose not to take part or may leave the study at any time. Leaving the study will not result in any penalty or loss of benefits to which you are entitled.
The study sponsor (those running the trial) will tell you about new information that may affect your health, welfare, or willingness to stay in the study.