We want to answer your most common questions!
FAQs
Frequently Asked Questions
Find answers to commonly asked questions about participating in clinical trials.
What is a clinical trial?
A clinical trial is a research study conducted with human volunteers to evaluate the safety and effectiveness of new medical treatments, interventions, or devices.
Why are clinical trials conducted?
Clinical trials are conducted to determine whether a new treatment is safe and effective for patients. They help researchers understand how treatments work, identify potential side effects, and compare new treatments to existing ones.
What is the difference between Phase 1, Phase 2, and Phase 3 clinical trials?
Phase 1: Tests safety in a small group, typically healthy volunteers, but sometimes patients with the specified medical condition.
Phase 2: Checks effectiveness, safety, and dosing in a larger group of people with the specified condition.
Phase 3: Confirms effectiveness and safety in the largest group of people with the specified condition.
After what phase does a drug get FDA approval?
A drug typically receives FDA approval after successful completion of Phase 3 clinical trials. The trial’s data is heavily reviewed to confirm evidence of its safety and effectiveness.
Who can participate in a clinical trial?
Eligibility criteria vary depending on the specific trial, but participants are typically selected based on factors such as age, gender, medical history, and the condition being studied.
What are the risks and benefits of participating?
Participants may experience benefits such as access to new treatments and closer monitoring of their condition. However, there are potential risks, including side effects from the treatment and uncertainty about its effectiveness.
What is informed consent?
Informed consent is the process of providing participants with information about the trial, including its purpose, procedures, potential risks and benefits, and their rights as participants. Participants must voluntarily agree to participate after understanding this information.
Does it cost to participate in a clinical trial?
No, typically all protocol-specific tests, assessments, and procedures are covered by the trial, and participants incur no costs.
What happens during a clinical trial?
Participants are usually assigned to receive either investigational treatment or a control treatment/placebo. They are closely monitored throughout the trial, often through regular visits to the study site, to assess the treatment’s effects and any side effects.
Will I receive compensation for participating?
Compensation policies vary by trial and may include reimbursement for travel expenses, time spent participating, or compensation for inconvenience. However, compensation should not be the primary reason for participating in a trial.
Can I stop the trial?
Yes, participants can leave a clinical trial at any time, for any reason. It’s important to discuss any concerns with the study staff before making this decision.
Can I still see my regular doctors during the trial?
Yes, participants should continue to receive medical care from their primary doctor during the trial.
Will I be informed of the trial results?
In many cases, participants are informed of the trial results after the study is completed. However, this may not always be the case, particularly if the results are preliminary or if the trial is ongoing.
What if I still have questions?
Please call 319-888-8270 or email slarson@cvmspc.com