Is a Clinical Trial Right for You?

Nearly every cancer treatment currently in use is the direct result of clinical trials, and we need patients to volunteer for these trials now more than ever.


Clinical Trial | CU Gyn Onc | Denver | Woman with doctorAfter being diagnosed with cancer, patients and their loved ones have to make a number of decisions about treatment. These decisions can be very complicated. While doctors at CU Gynecologic Oncology try to lay out all the options as clearly as possible, there is a lot of new information that patients and their family members will need to take in.

One often over looked option is the chance to participate in a clinical trial. A clinical trial is a scientifically controlled study where one or more human subjects are assigned one or more interventions to evaluate a safe and effective way to prevent, detect or treat a cancer, as well as to improve the quality of life for the patient.

Currently less than 5 percent of adults with cancer choose to participate in a clinical trial – even with research showing that participating can help a cancer patient live longer.

A clinical trial provides information to researchers about an investigational treatment that may help your condition, along with helping all other current and future patients with that form of cancer. A clinical trial must be done before a drug is approved by the U.S. Food and Drug Administration.

Bringing a treatment such as a new drug to a clinical trial is one of the final stages of a long research process. On average researchers study a cancer drug for at least six years in a lab before it even makes it to clinical trials. But the major hurdle in making a new cancer drug is how long it takes to complete the clinical trials. On average it takes about eight years from the time the clinical trial starts for the drug to get approved.

The long wait is to make sure the treatment is safe and effective. Each trial may include hundreds or even thousands of people. It takes time to find people interested in participating in a trial and who fit the trial’s criteria.

Clinical trial requirements can include factors or conditions that a patient must or must not have. Example criteria include a person’s medical history, disease type, age and current health. These criteria are set so that the people participating do not have too many medical differences. They are also established in order to keep participants safe by not allowing them to be in trials that may do them harm.

Why clinical trials matter

Nearly every cancer treatment available today is the direct result of clinical trials and research.

The most common types of clinical trials for cancer follow.

  • Cancer treatment trials that test a new drug, or a combination of drugs, and approaches to radiation therapy, surgery or new ways to use existing treatments.
  • Cancer prevention trials that test new ways to prevent cancer in people who have not previously had it, or to stop it from returning in people who had it.
  • Diagnostic trials that study new ways to understand a specific disease.
  • Screening trials testing better ways to detect cancer.
  • Supportive care trials explore options to improve quality of life for people with cancer.

Our researchers are looking for women to participate in several clinical trials

While clinical trials can offer great hope to a patient, less than 5 percent of adults with cancer decide to participate. Without patients willing to join in clinical trials, treatment advances slow down.

The numbers of clinical trial participation are much different in children with cancer. In fact, according to the American Cancer Society, more than 60 percent of people with cancer under the age of 15 are treated as part of a clinical trial. Around three-quarters of children live long-term with cancer, compared with only half of adults treated for cancer living long-term. The higher survival rate in children is associated with the high participation in clinical trials.

Benefits and risks of clinical trials

When considering participation in a clinical trial, you should weigh the pros and cons. Some people decide that the risks overshadow the benefits. But others are willing to try a new treatment.

Benefits of a clinical trial include:

  • Gain access to a treatment that is not available outside of the trial
  • Help others by contributing to medical research
  • Your cost of treatment is often covered, and some clinical trials provide compensation
  • Receive expert medical care at a leading medical facility
  • Play a more active role in your own treatment.

Possible risks of a clinical trial are:

  • Treatment may not work or could be less effective than standard treatment
  • Could have side effects
  • May require more visits to the doctor
  • May include additional tests
  • If the treatment is successful it may not be available once you have completed your time in the study due to it still being tested.

People often ask me about placebos in clinical trials as a reason they would not be interested. A placebo is a purposefully inactive drug or treatment administered to a patient in order to compare its effect with those of the real drug or treatment in the study. Doctors do not use placebos often in cancer clinical trials.

When they are used, they are usually combined with standard treatment so that the patient is not hindered by participating in the clinical trial. Placebos could also be used when there is no standard treatment available or with treatment to manage side effects or symptoms.

When a placebo is part of the clinical trial you are interested in, the research team will let you know.

Learning about your options

The main reason people give for not choosing to participate in a clinical trial is that they didn’t know the study was an option for them. But there are many other reasons. Some would like to participate but do not meet the requirements. Others worry they could be harmed by an unproven treatment.

Choosing to participate in a clinical trial can be a complex decision. A clinical trial for a new treatment may be the best option for a patient, even though the outcome is unknown when they sign up. Other patients may volunteer for a clinical trial because they know that the research can help in treating other patients with cancer in the long-run. This can help patients feel they are making a difference for the future.

Talk to your doctor about your options if you are interested in participating in a clinical trial. New clinical trials are constantly being created. At CU Gynecologic Oncology we conduct our own clinical trials but also can look at a number of organizations for other studies for which you may be a good candidate.

Ten questions to consider when talking to your doctor.

  • What is the purpose of the trial?
  • How long will I be enrolled in the trial?
  • What kinds of treatments and tests are involved?
  • Why do the researchers feel this treatment is better than the standard treatment?
  • What are the possible side effects or risks, and how do they compare to the standard treatment?
  • How do doctors know if the treatment is working?
  • Who would be my point of contact for my questions during and after the trial?
  • Who will pay for the care I receive during the clinical trial, and who pays if I am injured in the trial?
  • How often will I need to visit the doctor, and will I have to stay in the hospital?
  • What happens if I decide to leave the trial?

If you have the slightest interest in participating in a clinical trial, talk to your doctor and see if there are any you would qualify for.