As part of a major research center, we receive many questions about clinical trials. Some patients ask whether a new treatment can provide improvement for a disease that has compromised their vision. Others want to contribute to medical research that could lead to new and better treatments for their children or grandchildren.
Whatever your reason, it is a good idea to understand why the trial is being conducted and what are the potential benefits and risks of participating.
A clinical trial is a research study designed either to determine if a specific treatment — a drug or medical device — is safe and effective or to compare more than one form of treatment with another. Clinical trials will recruit two or more groups of patient volunteers who are typically randomly assigned into the different arms of the study. In some clinical trials one group of patients may receive the new treatment and the other group may receive either the standard treatment or a placebo (dummy) drug.
By the time a drug, device, or other treatment is used in a clinical trial, years of research have already taken place proving to scientists there is a good likelihood that patients will benefit from the new treatment and that the risks are low.
Several measures are in place to protect the safety of the patient and assure accuracy of results. Each trial has a specific set of criteria defining who is eligible to enroll so that the findings are valid. Participants are given an informed consent document that describes the trial in great detail, including potential risks and benefits. Clinical trials are run according to a carefully defined series of steps, called a protocol. Each person has ample time to ask questions before signing the consent.
Trials are funded by the National Institutes of Health, a funding agency, or a private company. They are governed by the Food and Drug Administration and may proceed through three phases:
- Phase I trials
- A Phase I trial address safety only. These trials involve a small group of healthy people and determine how a drug should be given and what dose will be safe.
- Phase II trials
- The Phase II trial continues monitoring safety but also begin to evaluate effectiveness of the drug, device, or procedure. These studies involve a larger group of people who have the disease or condition that is to be treated.
- Phase III trials
- A Phase III trial usually compares a new drug, group of drugs, device, or procedure against the current standard treatment. These studies address effectiveness and require a large pool of volunteer subjects to assure the validity of the findings. To eliminate bias, each participant is randomly assigned either to the current standard treatment or to the alternative treatment by a coin toss or by computer. Many Phase III trials are conducted nationwide, each center following the same stringent protocol to test the new treatment over a large and diverse population.
The Kellogg Eye Center routinely has between 10 and 20 clinical trials actively recruiting patients. They are listed on our website: http://www.umkelloggeye.org/patient-resources/clinical-trials.