Clinical Research Trials

Four Phases of Clinical Trials 

There are four types of clinical trials: Phase I, Phase II, Phase III and Phase IV.

Phase I

Phase I clinical studies are the first stage of drug testing on humans. They typically involve healthy volunteers and require in-patient stay for varying lengths of time. The trials typically test the safety, dosing and tolerability of certain medications.

Phase II

Once the drug’s safety has been determined in the Phase I trial, Phase II trials are performed on larger groups of volunteers to test for efficacy and toxicity.

Phase III

During this phase, trials are conducted across multiple trial centers on large groups of participants to definitively conclude a drug’s efficacy and monitor side effects.

Phase IV

Phase IV trials are post marketing studies after the drug is cleared for sale to further outline benefits and risks.

Clinical Trials vs. Treatment 

It is imperative to understand the difference between medical treatments and clinical trials. The treatment of medical conditions, and overall medical care, is inherently different than clinical research trials. Whereas medical treatments are administered by doctors through a personal plan that is specific to a patient, clinical trials follow a study protocol that applies to all participants, whether it is beneficial or not to a specific patient.

Medical treatments and clinical trials are terms commonly interchanged by the public who is unaware of their dissimilarity. When you enroll in a clinical trial, you are essentially taking part in an experiment. Clinical trials work to test and develop new drugs and treatments that will be safe and effective. Since their efficacy and safety is not known before the trial, as a participant, you are an integral part of the study determining whether these new drugs are helpful or valuable to patients with the targeted condition.

These clinical trials are not personal medical treatments designed specifically for your condition, and likewise, the new drugs have not yet been proven effective in treating your condition. Even if the proposed drugs are proven effective in the clinical trial, you may be in the control group receiving a placebo or the current “gold standard” treatment. Since clinical trials can be randomized, controlled and/or blinded, there is no guarantee you will be receiving the new drug or treatment.

This is not to say you will not likely receive quality medical care while participating in the clinical trial. However, it is most important to remember that clinical trials are designed for research, not to administer medical treatments. Educating yourself on the difference between medical treatments and clinical trials will assist you in making the best decision for yourself and your medical care.