About Clinical Studies/Trials

• What is a clinical trial?
• What are the benefits for participants?
• Who can participate?
• What happens during a clinical trial?
• What are the risks for participants?
• What are side effects and adverse reactions?
• What are the phases of a clinical trial?
• What is a protocol?
• What is a placebo?
• What is a control group?
• What if I already have a doctor?
• Do I get paid to participate in a clinical trial?

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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:

• Can play a more active role in their own healthcare by helping with the evaluation of new medications or devices.
• May get new research treatments that could work for the treatment of your condition and that could not be obtained outside the trial.
• Help the future of others and yourself by participating in medical research.
• Receive closer monitoring and associated medical care. All visits and procedures related to the study are free of charge. Those may include physical examinations, doctor visits, EKG, dietary counseling, study medications, laboratory tests.
• May receive compensation for participation in the trial.

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 healthcare 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 outweigh the benefit for you. The risks may include:

• The investigational treatment may not be effective for some participants.
• There may be unpleasant, serious, or even life-threatening side effects from the trial treatment.
• The protocol may require more of the participant’s time and attention than the participant can give.

Even in phase 1 or 2 trials, the treatment product 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 such events 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 of 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:

• Phase 1: Phase 1 trials are the earliest trials in the life of a new drug or treatment. The investigational drug is tested in a small group of people (20-80) to establish safe dosage ranges, identify side effects, learn how the body copes with the drug, and determine if the treatment actually treats the disease. The participants entering phase 1 are often healthy individuals. Phase 1 trials are important because they are the first step in finding new treatments for the future.
• Phase 2: Phase 2 trials are conducted with a larger group of people (100-300). Phase 2 determines if the new treatment works well enough to test in phase 3. It tests the effectiveness and safety and identifies side effects.
• Phase 3: Phase 3 trials are conducted with a much larger group of people (1,000-3,000) to confirm product effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the investigational drug or treatment to be used safely.
• Phase 4: Phase 4 trials delineate additional information including the drug’s risks, benefits and optimal use, also addressed are post-marketing safety studies.

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; and 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.
 

The preceding information is sourced from: www.clinicaltrials.gov; www.fda.gov