Clinical Trials

What Is a Clinical Trial?

Clinical trials, or studies, are a form of research that involves people like you. This research intends to answer specific questions involving medications, medical devices or new ways of using known treatments. Clinical trials do not replace primary health care. Instead, a patient's healthcare provider works closely with the research team to ensure medications or treatments do not conflict with the study. When you volunteer to take part in a clinical research study, you help doctors and researchers learn more about disease and advance research in ways that will improve care well beyond your own.

Clinical trials can study:

New drugs or new combinations of drugs for treatment

Access to National Research Right Here at Home

Carle is one of only 32 U.S. healthcare providers to receive the designation as a National Cancer Institute Community Oncology Research Program (NCORP). As a NCORP member, Carle oncologists join a national network of researchers dedicated to conducting high-quality, state-of-the-art clinical studies in local community settings. This affiliation allows our patients access to nationwide studies while staying close to family, friends, support systems, and local physicians.

Who Conducts a Clinical Trial?

A strong clinical research program addresses today’s critical healthcare challenges to improve patient care. At Carle, we accomplish that research mission through Stephens Family Clinical Research Institute, which enables research scientists, doctors, nurses, social workers, dietitians and other healthcare professionals to work together in innovative ways. The mission of the institute is to support, nurture, test and apply new discoveries that address today’s critical healthcare challenges.

A principal investigator, who is often a medical doctor, leads every clinical study. Clinical studies can be funded by pharmaceutical companies, academic medical centers, voluntary groups, and other organizations, in addition to Federal agencies such as the National Institutes of Health, the U.S. Department of Defense, and the U.S. Department of Veterans Affairs. Doctors, other health care providers and other individuals can also sponsor clinical research.

How Are Clinical Trials Approved?

The Food and Drug Administration (FDA) and the Office of Human Research Protection (OHRP) develop the policies and guidelines for all medical research. An Institutional Review Board reviews and approves all study-related documents, such as protocols, informed consent forms, physicians’ credentials and eligibility and patient recruitment materials.

Phases of a clinical trial:

• PHASE 1: Is the treatment safe and effective? Emphasizing safety, only a small number of participants receive the new research treatment. Researchers determine how best to safely deliver the treatment.
• PHASE 2: How well does the treatment work? Researchers examine the effectiveness of the treatment as well as its side effects on the particular disease or condition being evaluated.
• PHASE 3: Is the treatment potentially better than the treatments currently available? Participants in a phase 3 trial are randomly assigned to different treatment groups to find out if the new treatment is better than the standard treatment.
• PHASE 4: What are the long-term side effects and risks of the treatment? If a new treatment is approved by the FDA, researchers continue to monitor it to learn how it works over the long term.

Patient safety in clinical trials

As you consider joining a trial, you must first know that the fundamental principle of any trial is the safety and well-being of the trial participant. This takes priority over the interests of the scientific research. Having a full understanding – not only of the risks, but also the safeguards and the potential benefits of participating in clinical research – allows patients to make a truly informed decision with the confidence.

All clinical trial participants are guaranteed the same level of care non-participants receive.

Patient rights and informed consent

The informed consent process protects participants. It is a process that researchers use to provide potential and enrolled participants with information about a clinical study. This information helps people decide if they want to enroll or continue to participate in the study. It should provide enough information for a person to understand the risks of, potential benefits of, additional procedures, tests, and assessments as well as alternatives to the study. In addition to the informed consent document, the process may involve recruitment materials, verbal instructions, question-and-answer sessions, and activities to measure participant understanding.

In general, a person must sign an informed consent document before joining a study to show he or she has received and understands information on the risks, potential benefits, and alternatives. Signing the document and providing consent is not a contract. Participants may withdraw from a study at any time, even if the study is not over.

Why Take Part in a Clinical Trial?

While clinical trials are important, the choice to participate in one is very personal and depends on your unique situation. Patients participate in clinical trials for many different and personal reasons:

Participants who play a more active role in their own health care can gain access to new research treatments before they are widely available and help others by contributing to medical research. Consult your physician for advice on weighing the benefits and risks of participation.

Patients participating in clinical trials undergo particularly careful medical examinations and their treatment progress is precisely monitored.

Participating in a clinical study contributes to medical knowledge. Clinical trials offer hope for many people and an opportunity to help researchers find better treatments and improve healthcare for people in the future.

Eligibility is also a factor as you consider participating in a clinical trial. All clinical trials feature guidelines about who may or may not participate. Criteria can include 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.

Questions to Ask About Treatment Clinical Trials

If you are learning about a clinical trial or considering participating in one, we encourage you to have meaningful conversations with your doctor, family and friends. Having an open dialogue can help everyone understand the benefits and risk up front. To help you begin these conversations, we’ve assembled some common questions:

• What is the purpose of the trial?
• What are the benefits?
• What are the side effects and risks?
• How many people are being recruited to the trial?
• What will the study involve?
• How often will I have to visit the clinic?
• How long will I be in the study?
• Will I be told the results?
• How can I find out what clinical trials are being offered?
• What kind of therapies, procedures and/or tests will I have during the trial?
• How will the trial affect my current treatment plan and my daily life?
• Will I be taken off my current treatment, or will I continue to take my regular medications while in the trial?
• What is the procedure for opting out of this study once I’ve started it?
• Will there be costs for me if I participate?
• Will my insurance cover the costs?

Additional Resources

We appreciate your interest in learning more about clinical trials and hope to provide you with useful information that may help you in considering all your treatment options.

National Library of Medicine and National Institutes of Health

National Cancer Institute