Cancer Clinical Trials: Answers to Frequently Asked Questions

Finding more effective treatments for cancer requires extensive research. This work begins in the laboratory. And cancer patients play an essential role, too. By volunteering to participate in clinical trials, patients help researchers discover whether new drugs and treatment strategies work.

These answers to common questions about clinical trials to give you a better understanding of what they are and how you can get involved in them.

What is a clinical trial?

Clinical trials are research studies that — with the help of volunteer cancer patients — test the effectiveness and safety of new treatments, drugs, medical strategies or devices. These trials are the final stages of cancer research. In the trials, new developments are compared to current standard treatment practices. These studies must be conducted before a drug, treatment or device can be approved by the FDA. The overall purpose of clinical trials is to improve cancer treatment outcomes for patients.

What are the different kinds of clinical trials?

Clinical trials are categorized in four phases:

Phase 1 clinical trials involve relatively small groups of patients (15 to 30). They help determine maximum safe dosages of new drugs, which have gone through laboratory testing. These trials closely monitor patients for side effects and organ function. Phase 1 trials also help determine the best way to administer a new treatment.

Phase 2 trials, once drug safety has been established, involve larger groups of patients (usually less than 100) to monitor the response of tumors to the treatment that’s under study. This phase further checks for safety.

Phase 3 trials often include thousands of patients to confirm previous findings and determine effectiveness over a wide range of people.

Phase 4 clinical trials are used to follow drugs and treatments after they gain FDA approval and go on the market.

Who performs cancer clinical trials?

Radiation, medical and surgical oncologists serve as clinical trial investigators. They often work with oncology nurses who help run the trials.

How do I learn about clinical trials?

You can find out about current trials by talking with your oncologist. Or contact one of the following:

How do I enroll in clinical trials?

Your oncologist can help you connect with a clinical trial’s participant coordinator to start the process. To enroll you must meet the trial’s qualification criteria.

Is there a cost to participate in clinical trials?

Before you enroll in a clinical trial, find out if any study-related expenses will be your responsibility. Insurance typically does not cover these.

Most clinical trial sponsors, however, pay the cost of new treatments that are under study. And in most cases, they pay for special tests, procedures or extra doctor visits that are part of the trial.

You may have additional travel and child care costs associated with these trial-related appointments. And you and your insurance will be responsible for costs associated with your standard cancer treatment.

What are the benefits of clinical trials?

The ultimate purpose – and benefit – of clinical cancer trials is to advance the state of cancer care.

When you sign consent to participate in a trial, you will be informed that the experimental treatment may not benefit you. It could prove to be less effective than the current standard of treatment.

However, if the new drug or treatment protocol proves to work better, you — as a trial participant — could be among the first to benefit.

You’ll also benefit from being cared for by a team of medical professionals who follow carefully designed practices based on the latest cancer care knowledge. These practices are reviewed before and during the trial to assure your safety.

Also, there’s the satisfaction of knowing that your participation will help other cancer patients, now and in the future.

What are the drawbacks of participating in a clinical trial?

Clinical trials may require an extra time commitment from you. You may have additional medical appointments and tests that are required for the study to monitor how you are responding to the treatment.

And some clinical trials are randomized. This means you may not receive the trial drug or treatment. In a randomized trial, participants are selected at random to receive the trial drug or treatment or a control treatment for comparison. The control could be a standard treatment practice, a placebo (“sugar pill”) or no intervention.

What is a double blind study?

A double blind study is a randomized clinical trial in which:

  • You as the patient don’t know if you’re receiving the experimental treatment, a standard treatment or a placebo, and
  • Your doctor doesn’t know.

Only those directing the study know the treatment that each participant receives.

Double blind studies prevent bias when doctors evaluate patients’ outcomes. This improves reliability of clinical trial results.

Should you have health complications during a trial, such as a possible drug reaction, your doctor can “unblind” you and find out which treatment you’re receiving. As a result, you could end up being removed from the study. But patients’ health and safety come first. Patients are closely monitored throughout clinical trials.

Why do we have clinical trials?

Clinical trials advance medical knowledge and patient care. They help determine whether a new drug or treatment works well and safely in people, and if it improves patient outcomes over what current standard treatments achieve. They also can determine:

  • Which treatments are most effective for certain illnesses or groups of people
  • If a treatment being studied is as good as what is currently available, but causes fewer side effects
  • Whether it works for certain types of patients not helped by current treatments
  • Whether the benefits of the new treatment outweigh risks

How does a clinical trial work? What is involved in a clinical trial from a patient perspective?

Clinical trial participants meet with their physician on a routine basis and undergo scans, blood work, other tests and treatment, following the specific action plan (also called a protocol) for the clinical trial. The protocol has been reviewed and approved for the patient’s safety. This routine is similar to standard cancer care, but the trial will follow a protocol designed to evaluate the effectiveness of the treatment.

Depending on the clinical trial, follow-up appointments can continue throughout the patient’s lifetime to monitor the disease.

If I participate in a clinical trial outside of the area, can I get my testing performed locally?

This may be done if allowed by the organization managing the clinical trial.

When is the best time to talk to my doctor about possible clinical trials that would work for me?

There’s not one best time, but a variety of opportunities to ask your doctor about clinical trials. This starts with when you are diagnosed. Other appropriate times include when your cancer isn’t responding to treatment, when the disease changes and whenever your doctor talks with you about your treatment.

American Cancer Society, Premier Health

Content Updated: July 12, 2018

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