What Patients Want to Know About Clinical Trials

What are clinical trials?

A clinical trial is a research study in human volunteers to answer specific health questions. Carefully conducted clinical trials are the safest and fastest way to find treatments that work in people, and new ways to improve health.

There are different kinds of clinical trials, including those to study:

• prevention options
• new treatments or new ways to use existing treatments
• new screening and diagnostic techniques
• options for improving the quality of life for people who have serious medical conditions

Clinical trials are conducted according to a plan called a protocol. The protocol describes what types of patients may enter the study, schedules of tests and procedures, drugs, dosages, and length of study, as well as the outcomes that will be measured. Each person participating in the study must agree to the rules set out by the protocol.

Why are clinical trials done?

Many clinical trials are done to see if a new drug or device is safe and effective for people to use. Clinical trials are also done for other reasons. Some compare existing treatments to determine which is better. The current, approved treatments are called the “standard treatments.” Sometimes clinical trials are used to study different ways to use the standard treatments so they will be more effective, easier to use, and/or decrease side effects. Sometimes, studies are done to learn how to best use the treatment in a different population, such as children, in whom the treatment was not previously tested.

In trials conducted by SERRI, researchers, doctors, and other health professionals administer the clinical trials according to strict rules set by the Food and Drug Administration (FDA). FDA sets the rules to make sure that people who agree to be in studies are treated as safely as possible.

Can anyone participate in a clinical trial?

The requirements for participation in a clinical trial vary based on the specific objectives for each trial, and it is important that participants fit the guidelines. Not everyone who applies for a clinical trial will be accepted. Volunteers may be excluded based on the eligibility criteria and/or the number of participants needed by the researchers to collect enough information to determine the safety and effectiveness of a therapeutic agent.

Are clinical trials safe?

The ethical and legal codes that govern a medical practice also apply to clinical trials. Every clinical trial in the United States must be approved and monitored by an Institutional Review Board (IRB) to make sure the risks are as low as possible and are worth any potential benefits. The IRB reviews research studies from a layperson's perspective to determine whether the clinical study documents are complete and understandable to the prospective participant. All trials involve some form of risk. However, the risks are always evaluated closely.

What are the benefits of participating in a clinical trial?

By participating in a clinical trial you will be able to gain access to promising new treatments before they are made widely available. Additionally, you will be helping others by contributing to medical research that will benefit other patients for years to come.

Where can people find out about clinical trials?

If you are interested in taking part in a clinical trial at SERRI, please review the trials we are currently enrolling to see if you qualify. If you have questions about a trial, please call us at (423) 826-8003. You can learn about other clinical trials now being conducted now by searching clinicaltrials.gov