Being a Research Subject

Research is an integral part of medicine. For new medications and devices to reach the public, the process is both arduous and expensive. In the development of new devices and medications several phases of research are needed. After initial safety and efficacy testing, these products will enter the phase of human testing. In many medical specialties participation in a clinical study is the only way to get a chance at new treatments. In oncology, for example, patients are often treated with the standard therapy and the new agent, and the results are compared side by side. The effectiveness of the new treatment is measured by patient survival rates. Tolerance of side effects and toxicity of new treatments are often secondary but important considerations for many studies.

The chance of getting either therapy is equal. This process is called randomization. In the best and most accurate clinical trials, the subjects are randomized equally to a treatment so as to remove the bias of the investigator or treating physician. This process results in a fair amount of angst for the subject because many have a preconceived notion that the new treatment is the better choice, and they often want it. The truth of the matter is that we often don't know whether the new treatment is better. In some cases, unfortunately, the new treatment may be worse, and the clinicians don't know this until the study is complete.

Another facet of being a research subject is being blinded to the treatment, which means that subjects don't know what treatment they have received. The treating doctor and study directors are often blinded also; they don't know the treatment and therefore can't bias the results. This type of blinding, called double-blind, also increases the chance that the results of the study will be more accurate.

In some studies the addition of a placebo is needed to keep the subjects from knowing they are in a different treatment group. This means that the pills or treatment are often indistinguishable by the doctor, study team and the patient. Examples of placebos are a sugar pill, which would be indistinguishable from an active pill, or an infusion of saline administered in place of an injection of active medication.

The process of being a study subject is often not easy and may not actually change the outcome of the disease process. Patients that are approached to be a research subject must understand fully what they are getting into. This consent process is crucial to the patient and researcher relationship. All questions must be fully answered, and the subject must not feel coerced to be a part of the study. A research subject has the option to quit the study at any time, and the decision to not participate in a study should not affect a patient's access to standard treatments. All clinical studies must have approval from a local or regional research review board prior to the enrollment of subjects. The approval of a study by one of these boards implies that the study meets national standards for the protection of human subjects.