Oncology Clinical Trials and Research Program

Clinical trials are research studies that evaluate whether a treatment/therapy, drug or device works as intended and is safe to use in people. Trials may examine ways to prevent, detect, diagnose, treat or measure the extent of a disease. They are important in the development of new treatments for serious diseases like cancer.

All new treatments must go through clinical trials before being approved by the Food and Drug Administration (FDA). Because it can take months or years to see if a cancer treatment does what it is meant to do, cancer clinical trials can take years to complete and often include many phases (see below).

To learn more about clinical trials, visit the National Institutes of Health online glossary.

Clinical Trials Glossary (NIH)

While everyone has the right to apply for participation in a clinical trial, studies have unique protocols with required qualifications for participants. Some factors that may affect eligibility for a trial include:

• Age or gender
• Current medications
• Other health issues
• Type and stage of cancer
• Past or current treatments/medications

Contact our team directly or through your current healthcare provider to learn more about which clinical trials you may be eligible for.

Cancer clinical trials help advance cancer care through careful study and evaluation of new treatments and therapies. Each clinical trial has its own set of risks and benefits. Clinical trials are not a guarantee that a person will have a better quality of life or live longer when current treatment (standard care) is not likely to improve their health or longevity.

Advantages to joining a clinical trial may include:

• Getting a new treatment designed by cancer experts
• Helping future cancer patients from the knowledge gained from your trial
• Cost assistance for medical care or testing from trial sponsor (must confirm costs before agreeing to join trial)

Possible disadvantages of clinical trials are:

• Unexpected or worse side effects than standard treatment
• Results of new treatment are no better than standard care
• More frequent testing and monitoring throughout trial

Not all patients in a trial will receive the innovative treatment; some trials compare existing treatments.

A new cancer treatment goes through several phases that are designed to build on one another. Each phase has a different purpose and is designed to answer certain questions. There are benefits and risks to participating in each phase of a clinical trial. Most of the time, patients who take part in a clinical trial are in only one phase of the study. Treatments move through the phases, but patients do not.

• Phase I trials test if a new treatment is safe and look for the best way to give the treatment. Doctors also look for signs that cancer responds to the new treatment. These trials include small groups of people.
• Phase II trials test if one type of cancer responds to the new treatment.
• Phase III trials test if a new treatment is better than a standard treatment. After phase III trials, a new drug application (NDA) may be submitted to the FDA to decide if the drug can be approved for standard use.
• Phase IV trials find more information about long-term benefits and side effects. These trials look at drugs that have already been approved by the FDA.

Before clinical trials in humans can start, pre-clinical lab trials are completed to show that a drug or treatment is likely to be safe for use in people. If a treatment seems promising in lab studies, the research must further be approved through an investigational new drug (IND) application that is filed with the FDA.

To learn more about the phases of clinical trials:

• American Cancer Society
• MD Anderson Cancer Center

Clinical research is regulated in the United States by the Food and Drug Administration (FDA). The FDA gives authority to conduct research to the Community Health Network research department, the individual investigator physicians or investigators (principal investigators), the institutional research board (IRB) which provides assurance of human subjects protection under OHRP, and network leadership. Internationally, there are protections that regulate the development and implementation of studies with human participants.

Before you decide to participate in a clinical trial, we want to ensure you have a clear understanding of the purpose/phase of the trial, treatment process, risks and benefits, costs, use of information and data, and more.

If you enroll in a research clinical trial, you will be asked to complete documents of informed consent so that you know the physical, emotional, financial and time requirements of the study; you will also be informed about who will have access to the medical and research data as part of the research process. This includes your care team, the network research team, the company (sponsor) examining the data, and the FDA or other groups providing oversight.

• Research data is protected by HIPAA and all our research agreements have safeguards to protect individual patient data.
• As a study progresses, your care team will inform you of any changes to the study, new risks or side effects.
• As a volunteer, you have the ability to unenroll from a study at any time.

To report a concern or learn more about clinical trials at Community, email ORA@eCommunity.com or call 317-621-3840.