Clinical Trials: What You Need to Know

Cancer clinical trials are research studies that involve people with cancer. The goal of these studies is to find better ways to diagnose, treat and prevent cancer. The results of the trials also provide information about how to reduce the risk of cancer in people who have not been diagnosed.

Clinical Trials

Clinical trials may provide an opportunity for patients to access the latest in cancer care and help identify future therapies for treatment. Today there are about 17 million post-treatment cancer survivors in the United States, mainly because the new therapies developed in clinical trials are helping people with cancer live longer than ever before. That is why it is so important to continue this research.

Patients are encouraged to discuss their treatment options with their health care team, including whether a clinical trial is a viable option. Doctors across the country and around the world follow treatment guidelines developed from the results of clinical trials so they can deliver the best possible care to their patients.

How Do Clinical Trials Work?

A clinical trial often starts with a scientific idea based on the results of laboratory research. Researchers who come up with these ideas usually work in cancer centers, universities, community clinics, pharmaceutical company labs or hospitals. If proven effective, a tested treatment may become the standard of care for that diagnosis.

Before any treatment is tested in a clinical trial, many scientists and physicians have studied how the drug is absorbed into the body, how long it lasts in the body and whether it should be given by mouth or intravenously (through a needle into a vein).

Together, doctors and researchers design the studies. An investigational new drug application is submitted to the U.S. Food and Drug Administration (FDA). Scientists from the FDA review the procedure, technology or drug and provide input. Experts review the trial at many additional points during its development and make sure that the clinical trial is designed with the overall goal of improving cancer care for patients.

Clinical trials that test new drugs or other treatments are done in phases. Each phase has a different purpose, including drug safety, effectiveness, long term side effects and a comparison to the standard treatment. If a new drug or treatment does not seem promising in the early phases, the research can be stopped.

Rights and Protections

People who take part in clinical trials have both rights and protections to make sure their privacy and well-being are taken care of. One of the most important protections is called informed consent.

This is a process to ensure that the participant understands all aspects of the study, including the risks and benefits. A written consent document is signed by a patient, stating that they have entered the trial of their own free will. The participant should retain a copy for their files.

As a patient in a clinical trial, you always have the right to leave a trial at any time for any reason. All patients have that legal and ethical right to cancel their participation at any time. Your doctor will also be in communication with the trial, and if it seems that the treatment is not working, the physician and patient together may decide to leave the trial.

Besides informed consent, you will be asked to sign another form called a HIPAA Authorization. The Health Insurance Portability and Accountability Act (HIPAA) allows doctors to use your health information as part of the report on the study without using your name or other personal details. Be sure to retain a copy of the authorization for yourself.

Each clinical facility has a committee called an Institutional Review Board (IRB). An IRB includes doctors, nurses, lawyers and people affected by cancer. The IRB reviews each clinical trial on a regular basis to make sure it is safe, ethical and is carried out properly.

If you have concerns about any part of being in a clinical trial, speak with a patient representative. The name and contact information for this person are usually included on the informed consent document at the institution. If a patient representative is not listed, ask if there is someone else you can speak with, such as a nurse or social worker.

Edited by Marissa Fors, LCSW, OSW-C