Clinical trials are research studies that evaluate the efficacy, safety, and tolerability of potentially new medical treatments. They are designed to find treatments to improve health and future medical treatments. Clinical trials are conducted under very careful supervision by the pharmaceutical companies and the FDA throughout the studies, and must adhere to strict guidelines that are outlined prior to starting any study. Additionally, approval by an independent Institutional Review Board (IRB), which is dedicated to the protection of study volunteers, is required prior to and throughout the course of every research study.

Medical treatment cannot improve without research and volunteers. By volunteering for a clinical trial you can help advance knowledge about future treatments that someday many people may benefit from. Benefits to volunteering include receiving medical evaluations, laboratory tests, and study related procedures, provided at no cost to you, opportunities to receive new treatments before they are available to the general public, access to expert medical care during the trial, and the knowledge that you are helping in the development of new medical therapies.

All clinical trials have standards outlining who can participate. The standards are determined by the pharmaceutical companies that sponsor clinical trials. The factors that allow someone to participate in a clinical trial are called “inclusion criteria” and those that disallow someone from participating are called “exclusion criteria”. These criteria are based on factors such as age, gender, the type and stage of a disease, previous treatment history and other medical conditions. Inclusion and exclusion criteria are used to identify appropriate participants and to keep them safe.

Informed consent is the process of learning the key facts about a clinical trial before deciding whether or not to participate. For every clinical trial there is a formal document, called “informed consent”, which provides information about the study, potential risks and benefits of participations, and outlines all study related procedures. Our team reviews and explains this form with every participant before they decide to participate in a clinical trial. Risks and potential benefits are explained in this document. The participant then decides whether or not to sign the document. Informed consent is not a contract, and the participant may withdraw from the trial at any time.