Frequently Asked Questions
What is a clinical trial?
Clinical trials are research studies that explore whether a medical strategy, treatment, or device is safe and effective for humans. These studies also may show which medical approaches work best for certain illnesses or groups of people. Once a new drug has been evaluated and is found to be safe and effective, it may be approved by the FDA for doctors to prescribe.
Who can participate in a clinical trial?
Clinical trials have specific eligibility requirements that must be met. This criteria varies and may include such factors as age, gender, the type and stage of a disease and previous medical treatment history. Some research studies seek participants with specific illnesses or medical conditions while others seek healthy participants.
What are the benefits of participating in a clinical trial?
Clinical trial volunteers participate in the development of medical therapies that may offer better treatments and even cures for life-threatening and chronic diseases. Possible benefits for volunteers include:
• The opportunity to play an active role in your health care and gain a greater understanding of your disease or medical condition.
• Health assessments related to the study from our board certified specialists.
• Study related medication and lab assessments at no cost.
• Access to promising new treatments often not available outside the clinical trial setting.
• Help others by contributing to medical research.
Do I need to have medical insurance to participate?
No medical insurance is required. All medical research services and study related materials are provided at no cost.
Are research studies safe?
Millions of volunteers participate in industry-sponsored clinical trials each year. Medical researchers, doctors, and other health care professionals conduct these clinical research studies according to strict rules set by the Food and Drug Administration (FDA) to protect clinical trial volunteers. Despite, the possible benefits of participating in a clinical trial, volunteers also face the possible risk that the experimental treatment may not be effective and or that there may be unpleasant or serious side effects.
Can I leave a research study once it has begun?
You are free to end your participation in a trial at any time. Early study termination procedures will be performed to ensure your safe exit from the study.
Where can I find more information about clinical trials?
• ClinicalTrials.gov – English and Spanish www.clinicaltrials.gov Telephone: 1-800-411-1222
• Food and Drug Administration (FDA) www.fda.gov Telephone: 1-888-463-6332
What questions should I ask?
You should obtain as much information as possible before deciding to participate in a clinical trial. You should also feel comfortable asking the following questions and discussing any issues or concerns with your clinical research team members:
• What is the purpose of the clinical trial?
• Why do researchers believe the new treatment being tested may be effective?
• Has the treatment been tested before?
• What kinds of tests and treatments are involved?
• What are the possible study side effects and benefits?
• How might this trial affect my daily life?
• How long will the trial last?
• Will hospitalization be required?
• Who will pay for the treatment?
• Will I be reimbursed for expenses?