Deciding to participate in a clinical trial is an important personal decision. These sections should provide you with detailed information about clinical trials. You can always contact our study research team to ask questions about specific trials. It is also helpful to talk to a physician, family members, or friends when deciding to join a trial.
What Is A Clinical Trial?
Typically medical research studies involving people are called clinical trials. Clinical research is one of the ways the medical world looks for better or new ways of treating illness and disease. The U.S. Food and Drug Administration (FDA) requires that all medications be thoroughly tested for safety and effectiveness before they can be marketed in pharmacies and prescribed by your doctor.
The Department of Health and Human Services (DHHS) defines a clinical trial as a controlled study involving human subjects that is designed to prospectively evaluate the safety and effectiveness of new drugs or devices or of behavioral interventions.
What Are The Benefits for Participants?
Qualified participants in clinical trials:
Who Can Participate?
People from all over the world participate in clinical trials in order to help themselves and others improve their quality of life. Volunteer participants must qualify for the clinical trial. Clinical trials have guidelines about who may qualify because each clinical trial attempts to answer specific research questions. These guidelines are called Inclusion / Exclusion Criteria. Inclusion criteria are those factors that allow someone to participate in the clinical trial. Exclusion criteria are those factors that disallow someone from participating. These Inclusion / Exclusion Criteria are important in medical research and help to produce reliable results, identify appropriate participants, and keep them safe. These criteria are based on factors such as Age, Gender, the Type and Stage of a disease, Previous Treatment History, and Other Medical Conditions.
What Happens During A Clinical Trial?
All volunteer patients are treated professionally and with care. Participating in a clinical trial is much like a regular visit to a doctor's office, hospital, or medical clinic. Our clinical trial team always includes doctors and nurses as well as other health care professionals. At the beginning of the trial they check the health of the participant and give specific instructions for participating in the trial. During the clinical trial study medication is administered. The participant is monitored carefully during the trial and tests and procedures are performed according to a research protocol. This research protocol is designed to measure the effectiveness and safety of the study medication or procedures.
What Are The Risks for Participants?
There will be some risk and participants are always closely monitored. Treatment will be stopped if the study doctor thinks the risks outweighs the benefits for you. The risks may include:
Even in Phase 1 or 2 trials, the treatment has been carefully researched in the laboratory before it is administered to patients.
What Are Side Effects And Adverse Reactions?
Side effects are any Adverse Events or effects of the investigational drug or treatment. Such effects may include events such as Headache, Nausea, Hair Loss, Skin Irritation, or other physical problems.
You will be informed of everything that the doctors know regarding the study product before you agree to take part in the trial. However, in Phase 1 trials, the researchers may not have sufficient information to advise you of side effects. It is important to note that you may withdraw from a trial at any point. Your participation is entirely voluntary.
What Are The Phases Of A Clinical Trial?
Clinical trials are conducted in phases. The trials at each phase have a different purpose and help scientists answer different questions. There are four different phases of clinical trials. These phases are called Phase 1, 2, 3, and 4:
What Is A Protocol?
A protocol is the study plan for all clinical trials. This plan safeguards the health of the participants as well as answer specific research questions. The protocol describes what types of people may participate in the trial, the schedule of tests, procedures, medications, and dosages, as well as the length of the study.
What Is A Placebo?
A placebo is an inactive substance with no treatment value. Investigational treatments are often compared with placebos to assess the investigational treatment's effectiveness. In some studies, the participants in the control group will receive a placebo instead of an active drug or investigational treatment.
What Is A Control Group?
In many clinical trials, one group of participants may be given the investigational drug or treatment, while the control group is given either a standard treatment for the illness or a placebo.
What If I Already Have A Doctor?
You should continue to see your doctor for all non-study related medical matters and discuss your participation in the clinical trial.
Do I Get Paid to Participate In A Clinical Trial?
You may receive compensation for time and travel while you are participating in the study. Volunteers are not charged for study visits and procedures.