Clinical Trials

Making the Decision to Volunteer in a Clinical Trial

Nearly all of the cancer-fighting drugs and devices currently available exist only because they were thoroughly tested beforehand. These tests, known as clinical trials, are research studies designed to evaluate the safety and effectiveness of new drugs or other types of therapies. If you’ve been diagnosed with cancer, a clinical trial may be one of many treatment options available to you.

The primary benefit of a clinical trial is access to the highest quality of cancer treatment, with the possibility of receiving a new treatment before it is widely available. People who have participated in a clinical trial have identified several perceived advantages to participation, including having access to the best available care, receiving newer/better treatment, receiving increased medical attention, playing an active role in their own health care, and making a valuable contribution to cancer research.

To make an informed decision about volunteering for a clinical trial, educate yourself about clinical trials and weigh the advantages and disadvantages of a trial recommended by your doctor.

Get the facts

Learn as much as you can about clinical trials because many myths have circulated among the general public. As a first step, know the difference between the myths and the real facts (see sidebar). You should also learn as much as you can about any specific trials for your type of cancer. Some people may think that a clinical trial is not an option for them because their doctor didn’t recommend it. However, if your doctor does not ask you about clinical trials, you should raise the discussion yourself. Ask your doctor and medical team about trials that may be appropriate for you.

Even if your doctor recommends a clinical trial, the decision is a personal one and is yours alone to make. Many individuals with cancer have found it helpful to talk about the decision with family members or friends. Ask your doctor if you can talk with someone who has participated in a previous trial. Such a conversation can be beneficial, as studies have shown that the overwhelming majority of clinical trial participants had a positive experience. Also ask your doctor or a member of your medical team about clinical trial resources available online or in your local community.

When educating yourself, think about how you learn best. Educational resources are available in a variety of formats, such as print (hard copy and online), Web-based interactive tutorials and video. Print materials may also be available in several languages and may be designed for people with varying levels of education. Talk to a member of your research team about choosing resources that best fit your needs and learning style.

Weigh the advantages and disadvantages of volunteering for a clinical trial. These have been detailed by cancer experts as well as by clinical trial participants themselves (Table 1). As you think about these advantages and disadvantages, focus on what is most important specifically to you. Make sure you understand the details of the particular trial you’re considering; asking several questions can help you in this decision-making process.

Table 1. Weighing advantages and disadvantages of clinical trials

Potential advantages Potential disadvantages
Access to the best possible care through treatment with either the current standard of care or a treatment thought to offer more benefit than the standard of care Lack of clearly defined side effects or risks associated with experimental treatment
Potential for being treated with a new drug before it is widely available Chance that experimental treatment may not be better than the standard of care
Close monitoring during treatment and follow-up (often more so than in routine practice) Potential that not all participants will benefit from experimental treatment
Chance to play active role in health care Need for frequent tests and clinic visits
Opportunity to help future generations of individuals with cancer Possible need for travel to clinical trial site

 

Your doctor can tell you about specific details that may be associated with the particular trial that he or she recommends. The research team will also explain the details of the study, including the benefits and potential risks, and if you agree to volunteer for a trial, you will sign an informed consent document to confirm that you understand what is involved in the study. You can take this document home and talk to your family and friends about the advantages and disadvantages of a clinical trial. The informed consent document is not a contract and does not obligate you to remain in the trial. You may withdraw from the trial at any time and you would be able to receive the standard treatment for your cancer outside of the trial.

Find your match

Find a clinical trial that’s right for you by first asking the members of your medical team if they can recommend a clinical trial that might benefit you. In addition, a number of government and private organizations provide listings of clinical trials and information about the trials on their websites (see "Find a clinical trial" box below).

Questions to ask before volunteering for a clinical trial

  • Why is this trial being done?
  • Why is it believed that the treatment being studied may be better than the standard treatment?
  • What are my other options (standard treatments, other studies)?
  • What were the results of any previous studies of this new treatment?
  • What are the possible side effects or risks of the new treatment?
  • What are the possible benefits?
  • How will the doctor measure if the treatment is working?
  • Can I choose to continue to get this treatment after the trial ends?
  • How long will the trial last?
  • What kinds of procedures or tests are involved?
  • What impact will the trial have on my daily life?
  • Will I have to travel to receive treatment? Will I be compensated for expenses?
  • How often will I need to travel to receive treatment?
  • Will I have to be hospitalized as part of the trial?
  • What type of long-term follow-up care will be done?
  • Will I still be under the care of my doctor, or will I see someone different?
  • What costs (if any) will be my responsibility to pay?

 

Find a clinical trial

If your doctor does not mention a clinical trial as an option for you, ask about this possibility. An increasing number of websites are available where both physicians and patients can find out about clinical trials:

 

Dispelling the myths of cancer clinical trials

MYTH: Some participants in a clinical trial will get a placebo (sugar pill) instead of treatment.
FACT: Participants in cancer clinical trials will receive the standard of care as a foundation and then the experimental treatment or a placebo will be added to it. They will never receive a placebo instead of a cancer treatment.
 
MYTH: Clinical trials are not safe.
FACT: Clinical trials have many built-in safeguards to ensure that participants’ rights and safety are protected. These safeguards include an institutional review board, data and safety monitoring board, and an ongoing informed consent process.
 
MYTH: Clinical trials are only for people who have no other options for treatment (a “last resort”).
FACT: Clinical trials of cancer treatment are designed for individuals with cancer of all types and stages.
 
MYTH: The cost of care in a clinical trial is not covered by health insurance.
FACT: Under the new health care laws, patient care costs (such as going to the doctor, any stays in the hospital or certain testing procedures) are covered by insurance. Research costs are those directly related to the study. It’s common for the trial sponsor to cover these costs but not guaranteed, and insurance does not typically cover research costs.
 
MYTH: Clinical trials only take place at large hospitals or cancer centers.
FACT: Many clinical trials are now done at local hospitals, cancer centers and doctors’ offices.
 
MYTH: Signing a consent form to participate “locks” you into staying in a trial.
FACT: Once you have signed a consent form, you are free to change your mind and not participate. You can also decide to drop out of a trial at any time for any reason.
 
MYTH: A clinical trial must be recommended by a doctor in order for a person to participate.
FACT: If your doctor does not talk to you about clinical trials, raise the topic yourself. You can also search for clinical trials online; contact information for trials is given.
 
MYTH: Clinical trials involve treatments with unknown safety and efficacy.
FACT: Phase III clinical trials involve treatments that have been shown to be safe and effective in earlier-phase trials. Phase III trials also include treatment with the standard of care, which has well-established evidence of safety and efficacy. Phase I and II trials are based on the results of preclinical trials showing the potential for efficacy and are carefully designed to ensure the safety of participants.
 
MYTH: Participants in clinical trials are treated like “guinea pigs.”
FACT: The overwhelming majority of clinical trial participants (97 percent) say they were treated with dignity and respect; 93 percent report having a positive experience in the trial.

 

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