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Clinical Trials FAQ

What is a clinical trial?

Clinical trials are research studies designed to observe the effects of a new medical intervention on human health outcomes. The aim of clinical trials is to develop new medicines that help people live healthier and more comfortable lives. To achieve this, researchers develop medications to improve the detection, treatment, management and prevention of various medical conditions or diseases.

 

Medication testing takes place in clinical trials. During a clinical trial, researchers find out whether an investigational medication is effective in treating the disease and well tolerated. Clinical trials might also compare or combine existing interventions, or evaluate how people respond to other health-related factors.

Types of clinical trials

Phase 1

tests a new medication for the first time in a small group of people.

Phase 2

looks at whether a medication causes side effects, how much of the medication gets into the bloodstream, what effects the medication has on the body, and how the body processes the medication to further evaluate its safety.

Phase 3

looks at how effective the medication is in treating the condition and whether the medication is well-tolerated for a longer period in a large population.

Phase 4

monitors the effectiveness of the medication in the general population after it has been marketed, and collects information about.

Where do clinical trials take place?

Clinical trials usually take place in medical clinics and/or hospitals.

Who is involved in clinical trials?

During a clinical trial, you will be supported by a dedicated team of researchers, coordinators, doctors and nurses. Each member of the study team is committed to your health and well-being. At each phase of medication development, government agencies check the results to see whether the medication can continue to the next phase.

What can I expect at the study centre?

During visits to the study centre, you will undergo tests and assessments. The purpose of these tests is to understand how your body is responding to the investigational trial medication. You may have the following tests and assessments at some point in the trial:

Physical examination

this is a general assessment of your body and its functions using inspection, palpation (feeling with the hands), percussion (tapping with the fingers), and auscultation (listening). This will be carried out by the study doctor.

ECG, or electrocardiogram

a machine records the electrical activity of your heart through small patches attached to your chest, arms and legs.

Vital signs

your blood pressure, pulse rate and body temperature, along with your height and weight, will be measured.

Blood test

blood samples will be taken via a small needle inserted into your arm. Tests will include a full blood count and routine safety biochemistry and coagulation tests, as well as additional samples taken to determine the level of study medication in your blood.

Urine test

urine samples will be collected for laboratory examination.

Questionnaires

you will be asked a series of questions about your condition and its effect on your everyday life.

Pregnancy test

a sample of serum (that is, a part of your blood) or urine will be tested for participating females who are able to have children to make sure that you are not pregnant.

Study medication

you will receive the investigational study medication or placebo.

Chest x-ray

a procedure that takes pictures of the inside of your chest; you will be exposed to a low dose of radiation during this procedure.

What is informed consent?

Before entering a clinical trial, informed consent must be given. This is in the form of a Participant Information and Consent Form (PICF), which is a document that explains the purpose and specifics of the trial, what participants will be required to do and how they will be involved. This document is for participants to read, understand and keep. A copy must be signed before commencing. You can request the study team to go through the document with you if there is anything that you do not understand. At the end of the day, we are here to support you, the patients.

How do I know if a trial is the right fit for me?

There are certain criteria that need to be met before someone is eligible to participate in a clinical trial. These include age, signs and symptoms of a condition, medical treatment, lifestyle as well as time and accessibility to where the trial is being held. It is important to carefully assess if you match the criteria and that you understand any potential risks involved. There is no guarantee that you will benefit from taking part in a clinical trial. And remember, clinical trials are voluntary. You are free to leave at any time and for any reason, with no penalty to you.