What is a clinical trial?
According to nih.gov, “Clinical trials are part of clinical research and at the heart of all medical advances. Clinical trials look at new ways to prevent, detect or treat disease. Clinical trials can study new drugs, new combinations of drugs, new ways to use existing treatments and new medical devices. Clinical trials can also look at new ways of doing surgery, behavioral changes to improve health and improving the quality of life for people with acute or chronic illnesses. The goal of clinical trials is to determine if the treatment, prevention and behavior approaches are safe and effective.”
Are there different types of clinical trials?
- Prevention trials look for better ways to prevent a disease in people who have never had the disease or to prevent the disease from returning. Approaches may include medicines, vaccines or lifestyle changes.
- Screening trials test new ways of detecting diseases or health conditions.
- Diagnostic trials study or compare tests or procedures for diagnosing a particular disease or condition.
- Treatment trials test new treatments, new combinations of drugs or new approaches to surgery or radiation therapy.
- Behavioral trials evaluate or compare ways to promote behavioral changes designed to improve health.
- Quality of life trials (or supportive care trials) explore and measure ways to improve the comfort and quality of life of people with conditions or illnesses.
What does a trial's phase mean?
As stated on nih.gov, clinical trials are conducted in a series of steps called phases. Each phase has a different purpose and helps researchers answer different questions.
- Phase I trials: Researchers test a drug or treatment in a small group (20 to 80 people) for the first time. The purpose is to study the drug or treatment to learn about safety and identify side effects.
- Phase II trials: The new drug or treatment is given to a larger group (100 to 300 people) to determine its effectiveness and to study its safety further.
- Phase III trials: The new drug or treatment is given to an even larger group (1,000 to 3,000 people) to confirm its effectiveness, monitor side effects, compare it with standard or similar treatments and collect information that will allow the new drug or treatment to be used safely.
- Phase IV trials: After a drug or treatment is approved by the FDA and made available to the public, researchers track its safety in the general population, seeking more information about its benefits and optimal use.
What are inclusion and exclusion criteria?
There are guidelines for each trial that researchers follow when deciding who can participate in a study. According to nih.gov, these guidelines are called inclusion/exclusion criteria. Factors that allow individuals to take part in a clinical trial are called inclusion criteria. Those that exclude or prevent participation are exclusion criteria. These criteria are based on factors such as age, gender, the type and stage of a disease, treatment history and other medical conditions. Before joining a clinical trial, one must provide information that allows the research team to determine whether the person can take part in the study safely.
Why should I consider participating in a clinical trial? How might it help me?
Patients take part in clinical trials for many reasons. Healthy volunteers may take part to help others and contribute to moving science forward. Patients with an illness or disease may also participate to help others and receive the newest treatment and/or to have added (or extra) care and attention from the clinical trial staff. Clinical trials offer hope to many and the potential to help researchers find better treatments for others in the future.
What are some of the possible benefits of taking part in a clinical trial?
- Helping others by contributing to knowledge about new treatments or procedures.
- Gaining access to new research treatments before they are widely available.
- Receiving regular and careful medical attention from a research team that includes doctors and other health professionals.
What are some of the potential risks associated with taking part in a clinical trial?
- Potentially unpleasant, serious or even life-threatening effects of experimental treatment.
- Substantial time commitment may be greater than a standard treatment, including visits to the study site, additional blood tests, additional procedures, hospital stays and/or complex dosage schedules.
If I do participate, will I continue to see my current doctor, will I see a new doctor or both?
While participating in a clinical trial, all patients will continue to see their respective doctors. Sometimes, it is necessary to see a study doctor for certain parts of the trial. The study doctor is specially trained to monitor all patients participating in the clinical trial. The study doctor always keeps the respective patient’s health care team aware of how things are going.
Does insurance cover the costs of participation or will there be extra costs associated with participation?
Most insurance companies cover standard-of-care costs related to a clinical trial. There are some research studies where the study sponsor pays for certain items and services. Each patient needs to contact their insurance company directly to understand their specific insurance policy and how research studies are covered. During the informed consent discussion with the study team, all this information is reviewed in detail.
Patients are encouraged to ask their Northside health care provider about clinical trial options currently offered.
Learn more about clinical trials offered at Northside Hospital.
