Clinical Trials FAQ's
What is a clinical trial?
A clinical trial is a research study with human volunteers that aims to answer specific health questions and to develop new medicines and treatments.
Why participate in a clinical trial?
Participants in clinical trials play an active role in helping new medicines come to market. Volunteers have access to new treatments before they are widely available and help others by contributing to medical research. Additionally, participants receive services such as physical examinations, laboratory tests, psychological assessments and medications at no cost to them.
All trials have guidelines, called inclusion/exclusion criteria, that determine who can participate. These criteria are based on factors such as age, gender, the type or stage of a disease or disorder, previous treatments and other health conditions. This helps to identify appropriate participants and to keep them safe. All the studies are conducted in strict adherence to Good Clinical Practice guidelines to ensure patient well being.
What happens during a clinical trial?
The process depends on the type of trial being conducted. Each trial has a dedicated doctor and nurse. They check the health of the participant at the beginning of the trial, give specific instructions for participation, monitor the participant during the trial and keep in touch after the trial is over. Some trials have more tests and office visits than the participant would normally have for the same illness or condition treated in an office setting.
- Clinical trials investigate either medication or treatment for a specific disease or disorder.
- Prevention trials look for better ways to prevent disease.
- Diagnostic trials find better tests or procedures for diagnosing a particular disease, disorder or condition.
- Screening trials test the best way to detect certain diseases, disorders or conditions.
- Quality of Life trials are supportive care trials that explore ways to improve comfort and the quality of life for individuals with a chronic illness.
What is an informed consent?
An informed consent is a process in which the participant learns the key facts about the trial before deciding to participate. To help with this decision, the doctor and/or nurse will explain the details and answer questions regarding the trial. Details include the purpose, duration, requirements and key contacts. Risks and benefits are also explained. After full information has been received and understood the participant decides whether to sign the document for participation. The informed consent is not a contract.
Can the participant leave the trial after it has begun?
Yes. A participant can withdraw consent from a clinical trial at any time. Participation is completely voluntary. However, if participant consent is withdrawn the participant must let their research team know immediately and return any unused medications or supplies.
Should I join a trial?
People volunteer to participate in clinical trials for many different reasons. Some want to help in the advancement of science. Others may be suffering from a disease for which a good treatment does not exist yet. Most participants want to improve medical care they currently receive. Also, some don’t have health insurance and clinical trials are a way to receive study-related medical care at no cost.
Future participants may have more questions about trial and drug research and should speak with their physician and their research center’s staff before volunteering for a clinical trial.
