• A clinical trial is a research study involving human volunteers that seeks to answer specific health questions.
• Nearly every clinical trial begins with an idea in the laboratory.
• Researchers test new therapies/procedures in a lab and conduct preliminary, non-human studies first.
• Every clinical trial has a plan known as a protocol designed to safeguard participant’s health and answer specific research questions.
• The research team, known as the pi (principal investigator/doctor), research nurses and clinical study coordinators (CRC) follow protocol and regularly. evaluate the participant’s health to assess the effectiveness and safety.
• Our clinical trials are approved and monitored by an institutional review board (IRB) that ensures the study is ethical, protects the rights of participants, and ensures risks are minimal and worthy of potential benefits.

• Helps scientists better understand your disease/condition which can aid in prevention, detection, diagnosis, and advanced treatment and/or procedures, potentially impacting millions of lives throughout the world and in the near future
• While playing a more active role in your health, it aids participant to learn more about your disease and/or condition
• Allows participant to have close comprehensive care with their physician and research team enabling them to frequently monitor safety, side effects, and participant’s response to the investigational product
• Access to cutting-edge treatments that are not yet available
• Allows the participant to potentially benefit from the treatment at little or no cost
• Some studies offer a small stipend for participants time and efforts

• Consultation:  Discuss with your physician whether a clinical trial could be a suitable option, based on your diagnosis and current treatment plan.
• Screening: Coordinate with our dedicated research staff to review informed consent, screening criteria, and study logistics.  This will ensure that the trial is a good fit for your health status and lifestyle.
• Once deemed an appropriate trial for you an informed consent is provided. The informed consent process involves key facts about a clinical trial before deciding whether or not to participate.  The consent form provides details such as its purpose, duration, required procedures, and key contacts. Risks and potential benefits are explained.  The participant then decides whether or not to sign the document.  Informed consent is not a contract, participating in a study is always voluntary and a participant has the right to withdraw from the study at any time.
• Enrollment: If you meet the criteria and decide to participate, you will be enrolled in the trial.
• Follow-up:  Once enrolled, you will follow a specific visit schedule for treatment and monitoring.  Our team will provide ongoing support and answer any questions you may have throughout the process.

• Ethical and legal codes that govern healthcare also apply to clinical trials
• Clinical research is federally regulated with built in safeguards to protect participants
• All studies follow a carefully controlled protocol
• As a clinical trial progresses, researchers report the result of the trial at scientific meetings, medical journals, and various government agencies
• Individual participants’ PHI (Protected Health Information) will remain un-identifiable and will not be mentioned in these reports

Yes. A participant can leave a clinical trial, at any time. When withdrawing from the trial, the participant should let the research team know about it, and the reasons for leaving the study.