Frequently Asked Questions

Your participation in any clinical trial is voluntary. Before you volunteer to participate, you will receive an informed consent document that explains the details of the study, including the potential risks and benefits, as well as your rights and responsibilities. A member of the research team will discuss the study with you and answer your questions so you can make an informed decision about whether, or not to participate. In addition, you have the right to ask questions throughout the course of the study and may withdraw consent (stop) at any time. Since the decision to volunteer for a clinical trial is a personal one, you should decide in close consultation of your health care provider, family members, and friends.

By participating in clinical research studies you not only contribute in the development of a new medication (which may help with your own personal condition), but it may also play an important role in helping thousands of patients worldwide who suffer from the same or similar ailment. Participating in a clinical drug study is one of the best ways you can add to the understanding of diseases which affect you or someone you love. Medical research helps the medical community and medical scientists and physicians to gain greater knowledge about various diseases and their treatments. While some research studies may offer cutting edge treatments never before tried, others may only be looking at how effective one drug compares to another one.

A clinical research “trial” or “study” is conducted to answer specific questions about  investigational medications, medical treatments or devices. All study participants are volunteers.  The studies may include a select, very specific group of individuals or may include thousands of individuals in various parts of the world. Clinical trials may also be referred to as interventional trials. Interventions include but are not restricted to drugs, cells and other biological products, surgical procedures, radiologic procedures, devices, process-of-care changes, preventive care, etc.

Government agencies typically must authorize a drug company’s proposal to conduct clinical research studies. Drug companies must do years of laboratory research before they can begin testing medicines in people. All research studies have strict guidelines and are overseen by these government agencies to ensure their safety and effectiveness.  The Federal Drug Administration (FDA) oversees all clinical trials in the United States.

All clinical trials have rules about who can participate. Using inclusion/exclusion criteria is an important principle of medical research that helps to produce reliable results. 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 such factors as age, gender, the type and stage of a disease, previous treatment history, and other medical conditions. Before joining a clinical trial, a participant must qualify for the study. Some research studies seek participants with illnesses or conditions to be studied in the clinical trial, while others need healthy participants. It is important to note that inclusion and exclusion criteria are not used to reject people personally. Instead, the criteria are used to identify appropriate participants and keep them safe. The criteria help ensure that researchers will be able to answer the questions they plan to study.