Submitted by Shelley Francella, FMH Clinical Studies Coordinator
Many of the most important questions about health, illness, treatment options, and new medications are asked and answered in the context of the clinical trial. The clinical trials process carries the science of medicine forward in its knowledge of disease and treatments.
Of course, the ultimate goal of clinical research is disease eradication or cure. As in any area of specialized interest, the world of clinical trials has its own unique language. Those who work in clinical trials tend to throw around terms that to most people seem foreign.
Clinical trials are a big part of the picture when it comes to cancer treatment, and having a basic working knowledge of the language of clinical trials may be helpful even if you are not directly involved in the clinical trials process.
Randomization: Many clinical trials use a randomization process in order to assign a specific treatment plan to a specific patient. Randomization is a process not unlike the flip of a coin wherein the treatment decision is taken out of the hands of the physician, the pharmacist, and the patient. This process is often performed by a computer. Information about a patient is fed into a computer, analyzed, and a treatment is assigned by the computer. This process ensures that the outcomes of the study are determined only by the treatment under study and not by other – often subjective – factors by helping to eliminate bias.
Placebo: Sometimes called a “dummy drug” or a “sugar pill,” a placebo is a drug that does not include active ingredients. The idea of taking such a treatment can be troubling, of course. Who would agree to take part in a clinical trial in which there was a possibility of not receiving a real medicine?
In the context of clinical trials, placebos are used when the active drug being researched has no proven efficacy for the disease in study. Patients often agree to participate in such a trial because this is the only way they may gain access to a new, drug being investigated. Giving all patients a treatment that seems similar in most respects is helpful to the process of determining the relative value of a yet unproven drug. Patients with similar diseases and stage of illness can be carefully studied for signs of response to treatment or disease progression.
Sometimes, during the course of a placebo-controlled clinical trial, the drug being studied proves to be beneficial early on in the study, and researchers notice that the patients on active drug are doing much better than those on placebo. If this is the case, the study will be closed down and then re-opened, allowing patients who previously were on placebo to receive active drug.