What is a clinical trial?
A clinical trial is a medical study designed to answer specific questions about potential new or existing treatments. These questions may include how safe a treatment is, whether it works, or the best dose to use. All potential new treatments must undergo testing in clinical trials and be approved by the FDA before they can be prescribed by doctors.
why participate?
Participating in a clinical trial can provide access to potential new treatments that have shown promise in earlier studies but are not yet available to the public. It also allows individuals to contribute to medical research that may benefit others in the future. Participants often receive close monitoring and care from study doctors and research teams.
Phases of Clinical Trials
- Phase 1:
- Purpose: To test the safety of a potential new treatment in a small group of people.
- Focus: Determining the safe dosage range and identifying side effects.
- Phase 2:
- Purpose: To test the effectiveness of the potential treatment in a larger group of people.
- Focus: Evaluating effectiveness and further assessing safety.
- Phase 3:
- Purpose: To confirm the potential treatment’s effectiveness, monitor its side effects, and compare it to commonly used treatments in a large group of participants.
- Focus: Gathering more information to ensure safety and effectiveness. This is the last phase before FDA approval.
- Phase 4:
- Purpose: To collect additional information about the treatment’s risks, benefits, and optimal use after it has been approved and is on the market.
Focus: Monitoring long-term effects and ensuring the treatment remains safe and effective.
- Purpose: To collect additional information about the treatment’s risks, benefits, and optimal use after it has been approved and is on the market.
What To Expect as a participant
As a participant in a clinical trial, you will undergo various tests and procedures, including blood and urine tests, imaging studies, and possibly biopsies or injections. These procedures are closely monitored by the study doctors and research team to ensure your safety. Here are some key aspects to consider:
Informed Consent
Before joining a clinical trial, you will receive detailed information about the study, including its purpose, procedures, benefits, risks, and precautions. You will have the opportunity to ask questions and discuss any concerns before signing the consent form.
Screening and Pre-Procedure Assessments
A thorough review of your medical history and a complete physical examination will be conducted to ensure eligibility. Blood and urine samples will be collected for various tests, vital signs will be measured and imaging studies will be performed.
Participation and Monitoring
You will have regular check-ups that include blood tests, urine tests, and imaging studies to closely monitor your health. This helps quickly address any side effects and ensure your safety. All treatments and tests related to the study will be provided at no cost.
Safety and Privacy
Your safety is a top priority. The trial includes multiple safety tests, and you will be closely monitored by the study team throughout the trial. Your personal information will be kept confidential, and any published results will not include your name or other identifying details.
Voluntary Participation
Participation in the trial is completely voluntary. You can choose to withdraw at any time without giving a reason, and withdrawing from the trial will not affect your standard medical care.
Common Questions About Clinical Trials
Need text here introducing common questions.
What are the potential risks ?
As with any medical procedure, there are potential risks. These include possible side effects associated with the treatment or procedures performed during the trial. The study team will discuss all potential risks with you before you decide to participate.
How is my safety protected during the trial?
Your safety is protected through regular health assessments, close monitoring by the study team, and oversight by independent safety committees. Any side effects or health issues will be promptly addressed.
How will my privacy be protected?
Your personal information will be coded to protect your identity, and only the study team and authorized personnel will have access to your data. Any published results will not include your name or other identifying details.
Can I withdraw from the trial if I change my mind?
Yes, you can withdraw from the trial at any time without giving a reason. Withdrawing from the trial will not affect your standard medical care.
