Understanding Clinical Trials

What is a clinical trial?

A clinical trial is research study to determine whether an experimental drug, device or treatment is beneficial to the advancement or improvement of patient care. Clinical trial is different from routine standard of care, which is often FDA-approved drugs.

Anyone regardless of age, sex or ethnicities can participate in research study as long as they meet the inclusion and exclusion criteria outlined by each specified condition and study.

Clinical Trials are necessary pathway to identify new medical treatments. Your participation in any clinical trial will provide invaluable information whether the particular treatment would be beneficial or not.

For anyone who is interested in participating in a research study, knowledge is important. The Clinical Research Coordinator will provide you with guidelines specified in the protocol to ensure your understanding of the study.

Patient Bill of Rights: as a research study participant, your rights and protection are our priority. We will work with you in understanding of the protocol and study procedures, ensuring that all questions or concerns are answered.
Confidentiality: The Health Insurance Portability and Accountability Act (HIPAA) prohibits health care providers from using or disclosing “Protected Health Information (HPI)” to others without the consent of the patient.
Inform consent process: Informed Consent is a voluntary agreement to participate in research. It is a process as outlined by FDA (21 CFR 50) and not merely signing a document. The participant will need to learn about the purpose of the study, the procedure involved, the potential risks and benefits.

Federally supported and searchable registry for clinical trials pertinence to your condition: www.clinicaltrials.gov
Additional sources include patient advocacy groups.

Read the inform consent and other documents carefully. Ask questions about the study and make certain that you fully understand the risks and benefits of the study.
It is important to adhere to the guidelines set forth in the protocol, such as the duration of the study, report any potential side effects, and inform the research team of any changes. These guidelines will be discussed with you by the Principle Investigator and Clinical Research Coordinator; whom are responsible for conducting the clinical trials.

If you decide that you no longer want to participate in a clinical trial, you simply inform the research team and they will discuss the process of withdrawal from the study.

The Institutional Review Board (IRB) will determine the amount and schedule of all payments to participants before the start of the study to ensure that the proposed method and timing will not result in any undue influence as guided by FDA (21 CFR 50.20).