Clinical Trials

Approved by the Cancer.Net Editorial Board, 08/2012

This page is currently under medical review. Please check back for updates.

Key Messages

  • Clinical trials are used to find out if a new cancer treatment or other new approach is safe and effective.
  • All clinical trials are carefully regulated and monitored to make sure they are safe for participants.
  • Clinical trials may offer an older adult with cancer a treatment option not yet available, and age should not be the only factor in a doctor's or patient's decision to participate in a clinical trial.

Older adults with cancer should consider all treatment options, including clinical trials. A clinical trial is a research study involving people who volunteer to test a new treatment to find out if it is safe, effective, and possibly better than the standard treatment. Nearly every cancer treatment available today is the result of a clinical trial.

Clinical trials test far more than drugs. A clinical trial may evaluate a new combination of existing treatments, a new approach to radiation therapy or surgery, or a new method of treatment or prevention. Supportive care trials look at new ways to help people manage side effects of cancer and cancer treatment, such as fatigue or pain.

Benefits of clinical trials for older adults

Clinical trials may offer an older adult with cancer a treatment option not yet available to the public, and, for some, may be the best treatment option available. Participants get expert medical care at leading health care facilities during a clinical trial. In some cases, trial sponsors pay for expenses related to participation in the research, such as transportation, meals, and accommodations. Many clinical trial participants also feel good about the fact that they are helping other patients with cancer by contributing to medical research.

Patient safety

Patient safety is the highest priority in clinical trials. Every research study is carefully regulated and monitored by independent committees and federal agencies to make sure it is safe. A participant’s health is checked by the research team—doctors, nurses, and other health care professionals—before the study begins and is monitored closely throughout.

Another way patient safety is protected is through informed consent. There is an informed consent document, as well as an ongoing informed consent process, both of which give patients the information they need to make educated decisions about starting a trial or staying with a trial. The document, which must be provided to and signed by every participant, provides written information on every aspect of the clinical trial, including the goals, potential risks and benefits, and treatment procedures. The ongoing informed consent process gives patients the opportunity to ask the health care team questions, get answers, and stay up to date on study-related information at all times.

Phases of clinical trials

Clinical trial research is done in distinct segments called phases. Each phase of a clinical trial is designed to provide different information about the treatment being tested, such as the dose, safety, and how well it works. The phases are described as phase I, II, and III (one, two, and three). If a new treatment is unsuccessful (such as being unsafe or ineffective) at any stage, it is not moved to the next stage.

  • Phase I trials aim to show that the new treatment can be given safely to people. These trials are usually available for people with any type of cancer.
  • Phase II trials provide more information about a treatment’s safety and how well it works in treating cancer.
  • Phase III trials define how the drug will be used for cancer treatment. In these trials, the drug is usually compared with a standard treatment and tested in a large number of people.

Learn more about the phases of clinical trials.

Considering a clinical trial

Your doctor can help you understand more about clinical trials and find ones that may be beneficial to you. If your doctor does not talk with you about the possibility of entering a clinical trial, start the conversation.

Consider asking:

  • What happens during a clinical trial?
  • What are the benefits and risks of participating in a clinical trial?
  • How will my safety be protected?
  • Will you continue to be a part of my care during a clinical trial?
  • If I participate in a clinical trial, will it make me unable to have other treatments?
  • What clinical trials am I eligible for?

Participation requirements

Almost all clinical trials allow older adults to participate and do not have age limits. However, each clinical trial has specific participation requirements that help keep patients safe and ensure researchers get the information they need. For example, having medical conditions other than cancer, such as heart disease or diabetes, may mean an older adult cannot participate in a particular study. Also, an older adult with cancer who is unable to understand all aspects of a study because of a health issue that affects the ability to think, reason, or recall facts, may not be able to participate because of informed consent.

Before participating

Once you identify a clinical trial that may be beneficial to you, ask the research team for as much information as possible before making a decision on whether or not to participate. Consider asking:

  • What is the purpose of this clinical trial?
  • What are the risks and benefits of this treatment?
  • What costs are covered by the study, and what costs will I be responsible for?
  • Are there tests that I will need to have to be evaluated for the study?
  • Where will the clinical trial take place?
  • What kind of treatments, tests, and other procedures will I have during the clinical trial? How often?
  • How frequent are treatments and follow-up visits?
  • How long will the clinical trial last?
  • How long after completing my current treatment will I be able to participate in the study?
  • How long will it take to find out if the treatment is working?

Participating in a clinical trial

If you decide to participate in a clinical trial, it is helpful to have a family member or caregiver with you when your doctor or the researchers give you information so that they too understand your rights and responsibilities. You can also ask for written instructions in addition to the informed consent document that outline exactly what to expect from the treatment and your role.

Never be afraid to ask questions if you are given information you do not understand or ask for more information. And, it is important to know that if at any time you want to leave a study, for any personal or medical reason, you can.

Get more information about clinical trials, review other questions to ask your doctor and clinical trial researchers, and search for open clinical trials.

More Information

Clinical Trials: What is Informed Consent, with Carolyn Runowicz, MD

ASCO Expert Corner: Placebos in Cancer Clinical Trials

Cancer in Older Adults