What is a clinical trial?
Clinical Trials produce high-quality data for healthcare decision making. Below are some of the frequently asked questions on research:
Clinical research trials are studies done to look at new medical, surgical, or behavioral interventions. These research studies rely and require human volunteers to participate. Clinical research studies are the primary way scientist and doctors add to medical knowledge and find new ways to treat, prevent, or detect diseases. New treatments can include things like, a new drug or combination of drugs, diet, new techniques or medical device (for example, a Parkinson’s pump). Often a clinical trial is used to learn if a new treatment is more effective and/or has less harmful side effects than the standard treatment.
Other clinical trials test ways to find a disease early, sometimes before there are symptoms. Still others test ways to prevent a health problem. A clinical trial may also look at how to make life better for people living with a life-threatening disease or a chronic health problem. Clinical trials sometimes study the role of caregivers or support groups.
Clinical trials fall under two categories
Observational-Simply observing behavior in a natural or uncontrolled setting and gather data on what is observed.
Interventional-Researchers are giving an investigational drug or using an investigational device to a patient volunteer (called a research subject) to see if this new investigational drug or device help treat or prevent a certain disease.
You are taking an active role in testing and finding new possible treatments for your condition. It takes time for new drugs to find their way to market and it could never happen with people to volunteer.
You might advance your knowledge of your indication. Following clinical trials (even without participating) can give insight into where the newest possible therapies are headed.
Access to investigational therapies that may improve symptoms, and/or advance science’s understanding of the disease indication.
Be fully informed on what you are volunteering for. Take time to read the consent form thoroughly and ask questions.
Consult with friends, family and healthcare provider if you feel unsure or need feedback on participation.
All clinical trials have risks, these potential therapies are still being investigated. Be honest with your clinical coordinator about your medical history, symptoms, and any side affects you experience during the trial.
Ask questions!
No, you should never be charged for research participation. In fact, many sponsors also compensate you for your time with a stipend as well as reimburse your travel, hotel, meals and many other costs that may accrue during the trial.
Generally, patients are still responsible for their routine medical care and non-trial medications.
WHAT ARE THE PHASES OF CLINICAL TRIALS?
Phase I trial tests an experimental treatment on a small group of often healthy people (20 to 80) to judge its safety and side effects and to find the correct drug dosage.
Phase II trial uses more people (100 to 300). While the emphasis in Phase I is on safety, the emphasis in Phase II is on effectiveness. This phase aims to obtain preliminary data on whether the drug works in people who have a certain disease or condition. These trials also continue to study safety, including short-term side effects. This phase can last several years.
Phase III trial gathers more information about safety and effectiveness, studying different populations and different dosages, using the drug in combination with other drugs. The number of subjects usually ranges from several hundred to about 3,000 people. If the FDA agrees that the trial results are positive, it will approve the experimental drug or device.
Phase IV trial for drugs or devices takes place after the FDA approves their use. A device or drug’s effectiveness and safety are monitored in large, diverse populations. Sometimes, the side effects of a drug may not become clear until more people have taken it over a longer period of time.
