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When considering volunteering for a clinical trial, it is important to make an informed decision. Below are answers to frequently asked questions that many potential volunteers have about participating in a study.
- Why participate in a research study?
- What is a clinical trial?
- Who can participate in a clinical trial?
- Where do the ideas for trials come from?
- How does a clinical trial work?
- What questions should be asked before choosing to participate?
- What can a patient in a trial expect?
- Does information remain confidential and private?
- What happens after the trial?
1. Why Participate in a Research Study?
As a result of our research efforts, our patients often have early access to promising investigational drugs and devices, radiation therapies, and surgical techniques that offer types of care that would not otherwise be available.
The benefits of taking part in a study include:
- High-quality care
- Access to new treatments or new drugs
- Close monitoring of your health for any side effects
- A chance to help others and improve treatment options
- Some portion of treatment may be paid by the clinical trial
2. What is a clinical trial?
A clinical trial is a research study in which volunteers receive investigational treatments under the supervision of a physician and other research professionals. These treatments are developed by pharmaceutical and biotechnology companies who select qualified physicians, also known as investigators, to conduct clinical trials to determine the benefits of investigational drugs.
Clinical trials are usually conducted in three phases (I, II, III). Only a small number of people participate in phase I trials while the later phases involve a larger number of volunteers.
3. Who Can Participate in a Clinical Trial?
All clinical trials have guidelines about who can participate. Before joining a clinical trial, a volunteer must qualify for the study. The factors that allow volunteers to participate in a clinical trial are called "inclusion criteria" and the factors that disallow volunteers from participating are called "exclusion criteria." These criteria can include age, gender, the type and stage of a disease, previous treatment history, and other medical conditions.
Some research studies seek participants with specific illnesses or conditions to be studied in a clinical trial, while others require healthy participants. It is important to note that inclusion and exclusion criteria are used to identify appropriate participants, promote participants' safety, and ensure that researchers learn the information they need.
4. Where Do the ideas for trials come from?
For Phase I-IV research, the ideas come from pharmaceutical or device companies. For outcome or comparative effectiveness research, the ideas come from our investigators – physicians, nurses, etc.
5. How Does a Clinical Trial Work?
In a clinical trial, a volunteer is usually assigned a specific study group. Volunteers in one study group may receive an investigational treatment or study drug while other volunteers may receive a placebo or a treatment already available.
A placebo is an inactive product used to assess the experimental treatment's effectiveness. The participant, physician, and research staff may not know which volunteer receives a placebo and which receives the active treatment. Not knowing which participants are receiving the active treatment allows the physician and research staff to objectively observe the volunteers during the study. Regardless of which treatment volunteers receive, however, the level of medical attention and care that each receives is the same.
6. What Questions Should be asked before choosing to Participate?
Patients considering participating in a clinical trial should talk about it with their physicians and medical caregivers. Potential volunteers should also understand the credentials and experience of the staff and the facility involved in conducting the study.
Questions to ask a physician or medical caregiver:
- How long will the trial last?
- Where is the trial being conducted?
- What treatments will be used and how?
- What is the main purpose of the trial?
- How will patient safety be monitored?
- Are there any risks involved?
- What are the possible benefits?
- What are the alternative treatments besides the one being tested in the trial?
- Who is sponsoring the trial?
- Do I have to pay for any part of the trial?
- What happens if I am harmed by the trial?
- Can I opt to remain on this treatment, even after termination of the trial?
7. What Can a patient in a trial expect?
In some studies, participants receive a physical examination and their medical histories are reviewed by either the study physician or a research staff member once they are enrolled in the study. The volunteers' health will continue to be monitored during and after the trial. A detailed description of what's expected of volunteers will be outlined in consent forms along with specific clinical trial information.
8. Does Information Remain Confidential and Private?
Access to personal information is usually available to the investigator and research team conducting the clinical trial. In some circumstances, the Institutional Review Board overseeing the research and the sponsor or contract research organization coordinating the trial will also have access to personal information. This is explained more specifically in the consent form that participating volunteers are asked to sign. As a clinical trial progresses, researchers report the results of the trial at scientific meetings, to medical journals, and to various government agencies.
9. What Happens After the Trial?
After a study phase is complete, the data is collected to determine the drug's effectiveness, if it is safe and if there are any side effects. Depending on the results, researchers then determine whether to stop testing or move to the next phase of study. After Phase III of a study is complete, researchers decide if the results are medically important and may submit them to journals for peer review. Data then may be submitted to the Food and Drug Administration (FDA) for approval.
If a drug is approved, pharmaceutical companies may continue to conduct studies that compare the new drug—in terms of its safety, effectiveness, and cost—to other drugs already on the market or assess a drug's long-term effectiveness and its impact on the quality of a person's life.