Clinical Trials at MUSC Hollings Cancer Center

Clinical trials are research studies in which real people participate as volunteers. Clinical research studies are a means of improving our understanding of disease, such as in observational studies, or developing new treatments and medications for diseases and conditions, such as in clinical trials, which are evaluating the effects of a biomedical or behavioral intervention on health outcomes.

There are strict rules for clinical trials, which are monitored by the National Institutes of Health for the trials it funds, and the U.S. Food and Drug Administration more broadly. Some of the research studies at the Clinical Center involve promising new treatments that may directly benefit patients. More information about cancer clinical trials can be found here.

The health of millions has been improved because of advances in science and technology, and the willingness of thousands of individuals like you to take part in clinical research. Participants in clinical trials can play a more active role in their own health care, gain access to new research treatments before they are widely available, and help others by contributing to medical research.

The role of volunteer subjects as partners in clinical research is crucial in the quest for knowledge that will improve the health of future generations. Without your help, improving the current delivery of medicine cannot be accomplished. However, there are questions that you can ask to help you decide if participating in a clinical trial is right for you. Click on the link below for a list of these questions.

Questions to Ask About Participating in a Clinical Trial (PDF)

All clinical trials have guidelines about who can participate. Using inclusion/exclusion criteria is an important principle of medical research that helps to produce reliable results. The factors that allow someone to participate in a clinical trial are called "inclusion criteria," and those that disallow someone from participating are called "exclusion criteria.” These criteria are based on such factors as age, gender, the type and stage of a disease, previous treatment history, and other medical conditions.

Before joining a clinical trial, a participant must qualify for the study. Some research studies seek participants with illnesses or conditions to be studied in the clinical trial, while others need healthy participants. It is important to note that inclusion and exclusion criteria are not used to reject people personally. Instead, the criteria are used to identify appropriate participants and keep them safe. The criteria help ensure that researchers will be able to answer the questions they plan to study.

The clinical trial team includes doctors and nurses as well as social workers and other health care professionals. They check the health of the participant at the beginning of the trial, give specific instructions for participating in the trial, monitor the participant carefully during the trial, and stay in touch after the trial is completed.

Some clinical trials involve more tests and doctor visits than the participant would normally have for an illness or condition. For all types of trials, the participant works with a research team. Clinical trial participation is most successful when the protocol is carefully followed and there is frequent contact with the research staff.

The ethical and legal codes that govern medical practice also apply to clinical trials. In addition, most clinical research is federally regulated with built-in safeguards to protect the participants. The trial follows a carefully controlled protocol. A protocol is a study plan on which all clinical trials are based. The plan is carefully designed to safeguard the health of the participants as well as answer specific research questions. A protocol describes what types of people may participate in the trial; the schedule of tests, procedures, medications, and dosages; and the length of the study. While in a clinical trial, participants following a protocol are seen regularly by the research staff to monitor their health and to determine the safety and effectiveness of their treatment.

Every clinical trial in the U.S. 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. An IRB is an independent committee of physicians, statisticians, community advocates, and others that ensures that a clinical trial is ethical and that the rights of study participants are protected. All institutions that conduct or support biomedical research involving people must, by federal regulation, have an IRB that initially approves and periodically reviews the research. The IRB will also ensure that patients are properly informed about the clinical trial.

Informed consent is the process of learning the key facts about a clinical trial before deciding whether to participate. It is also a continuing process throughout the study to provide information for participants. To help someone decide whether to participate, the doctors and nurses involved in the trial explain the details of the study. If the participant's native language is not English, translation assistance can be provided. Then the research team provides an informed consent document that includes details about the study, such as its purpose, duration, required procedures, and key contacts. Risks and potential benefits are explained in the informed consent document. The participant then decides whether to sign the document. Informed consent is not a contract, and the participant may withdraw from the trial at any time.

• Plan ahead and write down possible questions to ask.
• Ask a friend or relative to come along for support and to hear the responses to the questions.

As you think about taking part in a clinical trial, you will face the issue of how to cover the costs of care. There are two types of costs in a clinical trial: patient care costs and research costs.

Patient care costs are those costs related to treating your cancer, whether you are in a trial or receiving standard treatment. These costs are often covered by health insurance. They include:

• Doctor visits
• Hospital stays
• Standard cancer treatments
• Treatments to improve symptoms of cancer or side effects
• Lab tests
• X-rays and other imaging tests

Research costs are those related to taking part in the trial. Often these costs are not covered by health insurance, but they may be covered by the trial’s sponsor. Examples include:

• The study drug, but this typically excludes the administration of the study drug.
• Lab tests performed purely for research purposes.
• Added X-rays and imaging tests performed solely for the trial.

The National Cancer Institute provides additional resources about costs and clinical trials.

If you have questions about what are considered patient care costs or research costs, contact your study coordinator.

When considering a clinical trial, you should also contact your insurance provider about the coverage of your patient care costs. To understand what you may need to pay out of pocket for your patient care costs during the trial, you should speak with your insurance provider.

Whether you are someone who feels financially healthy or a person who is worried you can’t afford treatment, it’s important to understand the costs of your cancer care. Because of the many specialists involved and different tests and treatments you may have, knowing what costs to expect is key.

Additionally, when you take part in a trial, you may have extra doctor visits that you would not have with standard treatment. During these visits your doctor carefully watches for side effects and your safety in the study. These extra visits can add costs for transportation, housing, and childcare.

Tell your health care team if you think the costs of care could be a burden for you. Talking with them about these issues may make you feel uncomfortable, but they are there to help you. Your doctors need and want to know how costs are affecting you. Some patients say it makes them feel better to share their concerns with their doctor. Then decisions about what treatments to use and what medicines to prescribe can be made with those concerns in mind.

Talk with the billing office or a financial counselor at the hospital. If you’re worried about paying medical bills, ask them about options to make payment more manageable, such as:

• Payment plans
• Reduced rates
• Patient assistance
• Help from charities

If you are having a hard time paying your usual bills (such as mortgage, rent, or utilities) during your cancer treatment, talk to the bank or the companies that you owe. They may be able to set up a payment schedule to keep you from falling behind. It’s important to reach out to creditors as soon as you think you could have financial problems.

Learn where to find organizations and resources that offer financial assistance. One resource is the National Cancer Institute's (NCI) list of organizations that offer cancer support services. You can also call NCI’s Contact Center at 1-800-4-CANCER (1-800-422-6237) to ask for help finding referrals and resources.