What is a clinical trial or clinical study?
A clinical trial or clinical study is performed on volunteer participants that are aimed at evaluating a medical, surgical, or behavioral intervention. They are the primary way that researchers find out if a new treatment, like a new drug or diet or medical device is safe and effective.
What are the 4 phases of a clinical trial?
Clinical trials advance through four phases to test a treatment, find the appropriate dosage, and look for side effects. If, after the first three phases, researchers find a drug or other intervention to be safe and effective, the FDA approves it for clinical use and continues to monitor its effects.
Clinical trials of drugs are usually described based on their phase. The FDA typically requires Phase I, II, and III trials to be conducted to determine if the drug can be approved for use.
- A 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.
- A 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.
- A 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.
- A 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.
Are clinical trials safe?
Clinical trials are performed with the goal of advancing medicine though safe but effective discovery. Each trial is monitored by an independent Ethics Committee and Institutional Review Board with the safety of the participant in mind. Here at Spectrum Clinical Research we take the patients safety and wellbeing in mind when choosing what clinical trial we want to participate in. We cannot say the clinical trial is "risk-free" but we do everything within our power to lower the risk for our participants.
How do I participate in a clinical trial?
In order to participate in a clinical trial, a screening process will occur where our medical staff ask you a few simple questions about your medical history. We are trying to determine if you meet the requirements for the inclusion and exclusion criteria. This varies based on what is being research and which phase of the clinical trial is in.
Will I get paid for participating in a clinical trial?
Participation in a clinical trial is voluntary but you may be compensated for your time and/or travel. Compensation varies based on the study time, study length, and other requirements set forth by the clinical trial.
What if I have a friend or family member that would like to participate in a study?
Spectrum Clinical Research provides a referral bonus up to $1,000 for if a friend or family member is enrolled and completes a clinical trial.
What if I have more questions that have not been answered?
Please contact us at (816) 562-6466.