What is a Clinic Trial?
A clinical research trial, or “drug study,” is a scientific study that has been carefully designed to answer a very specific medical question. Typically, the maker of the drug, usually a pharmaceutical company and commonly referred to as the “sponsor,” generates the research question. Some studies test medications that are currently unavailable for treatment, referred to as investigational new drugs, whereas others examine medications that can be prescribed today. The sponsor develops a set of guidelines, or protocol, that research sites must follow in order to answer the question.
How Does it Work?
The US Food & Drug Administration (FDA) oversees all research activities in the US. Its goal is to ensure that medications available to the public are both safe and effective. The FDA works closely with the sponsor to ensure that the protocol is appropriately designed to answer the question(s). Typically, the FDA will request results from several studies, each answering a different question, before approving a new medication for release. All new medications are tested first in animals, then healthy human volunteers, and finally in patients with a specific disease.
Can I help?
Most clinical trials need large numbers of patients to answer the research question. Sponsors, however, do not have direct access to patients, so they ask medical practices with research experience, or investigative sites, to help. Depending on the number of patients needed for a trial, some studies require hundreds of sites located all across the US, and in some studies all over the globe.
Participating in a trial is a partnership or commitment between you and the study team. It requires more time and effort than just “going to the doctor” for a check-up. Patient volunteers are typically asked to keep careful record of their symptoms along with other conditions that might develop while in the trial. Most protocols require periodic visits to the site for exams, lab tests, and to receive new supplies of study medications. In short, patient volunteers receive a great deal of personalized medical attention, while at the same time, learning a fair amount about their underlying disease.
Patients participate in clinical research trials for different reasons. Most appreciate the detailed medical attention. Others do so to in order to potentially receive a new medication that others with the same condition are unable to receive today. Some do so solely for altruistic reasons – to be a part of advancing medical science. In addition, study-related medical care is provided at no cost, and for most protocols, patient volunteers are compensated for their time and travel.
Is It Safe?
Many people who consider participating in a clinical research trial will ask, “Is it safe?” In a nutshell, yes. With any investigational medication, however, where clinical experience is limited, extra safeguards are in place. First, most protocols require careful patient monitoring, which often involves serial lab tests, EKGs, breathing tests and physical exams. For many protocols with electronic recording systems, the site can even track your progress on-line between scheduled visits. Patient volunteers are not allowed to continue in a trial if any worrisome changes occur. Second, an independent group called an institutional review board, or IRB, ensures that all patients’ rights and welfare, are protected. The IRB approves the protocol, the site, and the consent form for the trial. The site will report any serious adverse events to both the sponsor and the IRB, whether felt related to the study medication or not. For events that are felt to be related, the sponsor must distribute the report to all sites participating in the trial. In addition, the IRB has the authority to immediately suspend any research activities if they have concerns regarding patient safety.
With the evolution of electronic medical records and the development of sophisticated databases, there is a good chance that you may be asked to participate in a clinical research trial at some point in the future. Think it over carefully.