Clinical trials are at the heart of all medical advances. Clinical trials are medical research studies that are conducted to investigate the safety and efficacy of potential new drugs and medical treatments, also referred to as investigational drugs, as well as their side effects and uses. Investigational drugs are not yet approved by the U.S. Food and Drug Administration (FDA) to be prescribed.

Clinical trials contribute to the development of medical knowledge and advancement of patient care. Clinical trials can provide another treatment option to patients in addition to standard therapies.

Prior to participating in a clinical research study, participants must voluntarily complete and sign an Informed Consent Form (ICF). The ICF contains information about the individual's rights as a research participant and a summary of the clinical trial, or clinical research study, including:

• Purpose of the research and duration of participation

• How the protocol (plan of research) works and the procedures to be followed

• Potential benefits, risks, or discomforts participants may experience

• Participation is voluntary and may be stopped at any time

• Contribute to medical and scientific advancement

• Offer an opportunity to help find better treatments for people in the future

• Learn more about your medical condition

• Receive compensation for your study-related time and travel

• Receive cost-free, study-related medical care, assessments, and procedures

• Access to new treatments and medications

• High-quality medical care and close monitoring from doctors, healthcare professionals, and clinical trial staff

Participation is voluntary, meaning it is your decision to participate in the clinical trial. You may decline to participate or withdraw from the study at any time.

ClinicalTrials.govis a website and online database of clinical research studies and information about their results. The U.S. National Library of Medicine (NLM) maintains the website. The study sponsor or investigator submits information about their study to ClinicalTrials.gov and is responsible for the safety, science, and accuracy of any study they list.

Information retrieved from: https://clinicaltrials.gov/