Through volunteering for a clinical trial, you help bring novel treatments to market, which ultimately benefits you as well as everyone else. A clinical trial may also give you access to a treatment otherwise not available. It may also provide you with a comprehensive medical evaluation at no cost
to you. Finally, it offers an opportunity to interact with physicians who are experts in the field.

Clinical trials involve treatments that the Food and Drug Administration (FDA) has not yet approved or that it has approved and we are now examining for another indication. Not only has the FDA given the trial its stamp of approval from a public-health perspective, an organization independent of the FDA, called Institutional Review Board (IRB), also scrutinized it and found it safe. In addition, both organizations follow trial progress in terms of safety and may put it on hold, temporarily or permanently, when those arise. Finally yet importantly, during the trial physician-investigators closely follow and monitor the participating volunteers to protect their health and well-being.

We refer to the sponsor as the organization, usually a pharmaceutical company, which provides the protocol, treatment, and, importantly, the finances to conduct the trial.

This document describes the reason for conducting a particular trial and spells out its scientific background and objectives as well as methodology, including but not limited to visits and visit procedures and assessments of efficacy and safety.

Clinical trials vary greatly in length; they are generally minimally several months but can last years. It is important to inquire about the duration when applying to make sure that it is doable for you.

The initial evaluation typically takes 2-3 hours. A good part of it consists of reading and discussing the informed-consent form. It is important to obtain solid understanding of what the trial involves in terms of visits and procedures and what the treatment consists of, including potential side effects and safety concerns. The follow-up visits are usually much shorter, generally 1 hour or less.

They are generally monthly but can range from weekly to quarterly; sometimes telephone visits are also part of a trial.