Participating in a clinical study ensures you can access investigational therapies that provide new or better ways to treat medical conditions. It’s also an important contribution to the future of rare disease management—more than 95% of rare diseases have no treatment.
If you’ve discovered and been accepted into a clinical study and are wondering what’s next, here’s what to consider.
What is a clinical study?
Clinical studies are part of clinical research that examines new ways to treat, prevent, or detect disease. Participating in a clinical study helps doctors and researchers improve health care and learn more about the disease and treatment strategies being studied.
Clinical Study Phases
Clinical studies are conducted in a series, often called “phases.” Each clinical study phase has a different purpose and builds on the previous phase. The information gathered during the phases help researchers answer questions like, “Is the treatment safe and effective?” Or “How well does the treatment work?”
- Pre-clinical phase: The first step in a clinical study involves experimentation in animal models to determine the safety and effectiveness of a potential drug or treatment. This information allows researchers to make informed decisions about human testing.
- Phase 1: Researchers use a small group of clinical study participants to test a drug or treatment for the first time to assess its safety.
- Phase 2: Once determined safe, the drug or treatment is given to a larger group of people to assess its effectiveness.
- Phase 3: Given to an even larger group to confirm its effectiveness, this phase monitors side effects, compares new treatment to standard therapy, and collects information.
- Phase 4: In the final stage of a clinical study, drugs and treatments are reviewed by the Food and Drug Administration (FDA). If approved, they are made available to the public, and researchers continue to look for side effects not found in prior phases to understand how it works over the long term.
Clinical study recruitment and enrollment happen for each clinical study phase. For example, depending on the study requirements, clinical study volunteers who are in a phase 2 clinical study may not be required to be in a phase 3 clinical study.
Clinical Study Process
Patient recruitment for a clinical study involves identifying, sourcing, and educating patients for initial discussions about a clinical study. Click here if you are interested in learning more about clinical studies PatientWing is supporting. Patient enrollment is the process clinical study participants undergo before the study officially begins.
A patient is considered enrolled when they complete screening and meet eligibility requirements. Once enrolled, you will connect with a study team of medical professionals conducting an extensive and thorough screening process.
During the screening process, you will meet with the study team to review the study's details and sign an informed consent form outlining the potential benefits and risks of the study. As a clinical study participant, you are permitted to ask questions before agreeing. Some common questions are as follows.
- What is the main purpose of the study?
- How long will the study take and what will be asked of me?
- If the research intervention works, can I continue using it after the study?
- Will I be able to see my doctor during the study?
- In a study that includes placebos, will I know which treatment I am receiving?
You’ll also provide written permission for additional screenings and assessment of your health records.
The study team will further assess your eligibility by asking various screening questions and conducting medical assessments. You may be asked to complete the following.
- Gather medical history and undergo a physical exam
- Measure height, weight, and vital signs (blood pressure and pulse)
- Complete an ECG/EKG to measure the electrical activity of your heart
- Collect blood and urine samples for lab assessments
- Administer other diagnostic tests as required
The information collected during the screening phase will be strictly confidential and used for assessment purposes only, ensuring your privacy and security.
Clinical Study Duration
During the clinical study, you’ll primarily interact with the study team—including the study doctor, nurses, social workers, and support staff. They will complete tests and exams related to the study. You may be asked to complete tasks outside of treatment to track your progress and offer additional insight. For example, keep a food diary to assess how the foods you eat interact with treatment.
What Happens After a Clinical Study ?
The final steps after a clinical study vary depending on the type of study conducted. In most cases, the study team will review the results and determine the next steps. At this point, clinical study participants are no longer needed unless otherwise noted. You may not receive individual results but a summary of collective findings in a published report.
