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Why are clinical trials important?

Published on | Eric Brown

Clinical trials are the final step in a long process that begins with research in a lab. Researchers devote many years to understand the treatment’s effect on cancer cells before a trial is open to patients.

It may come as a surprise to many people that doctors don’t always know which treatment is the most effective for a patient. They base their decision on years of medical knowledge and experience, results observed in other patients, collaboration with colleagues, and information obtained from medical conferences and journals.

Clinical trials are another valuable tool doctors and researchers use to discover new and more effective treatments that can help prevent, detect, diagnose and treat a variety of diseases.

The treatments can be new drugs, a new surgical procedure or device, or a new way of using existing treatments. Clinical trials also provide information on the benefits and safety of existing therapies.

Clinical trials are at the heart of all medical advances.

The dramatic progress that has been made in treating cancer over the past three decades predominantly has come from scientific research, including clinical trials. The patients who participate in these investigative studies gain access to the very latest changes in cancer care developed by the nation’s foremost cancer specialists.

Clinical trials are the final step in a long process that begins with research in a lab. Researchers devote many years to understand the treatment’s effect on cancer cells before a trial is open to patients.

According to the American Cancer Society, about 1,000 potential medicines are tested before one makes it to a clinical trial. On an average, a new medicine to treat breast cancer has been studied for at least six years before a clinical trial on it is started.

It was a randomized trial of the Salk polio vaccine in over 600,000 school children that led to the approval of the first preventive treatment for the disease. In addition, measles was nearly eliminated by a vaccine tested in clinical trials.

These trials offer hope for many people and a chance to help researchers find better treatments for others in the future.


What are the benefits of clinical trials?             

  • They identify the effectiveness of new treatments.
  • They provide options for people suffering from cancer or other diseases and conditions, while allowing physicians to improve the way they prevent, diagnose and treat that particular illness.
  • By participating in a clinical trial, you may receive an innovative treatment that may become the standard of care in the future.
  • You gain access to the latest advances available in the entire country. Participants also have access to experimental drugs or procedures that aren’t available yet. These treatments may be more effective or have fewer side effects that standard therapies.
  • You are contributing to medical research that may benefit future generations and save many lives. For example, many of the breast cancer treatments today – herceptin, tamoxifen, aromatase inhibitors and others – are available because large numbers of women opted to participate in clinical trials to test them.
  • You can play a more active role in your own health care.


What are the cons of participating in a clinical trial?

  • The new treatment may not work for you, even if it benefits other people in the trial.
  • The new treatment may not be as effective as what is currently available.
  • There may be more side effects to the new treatment than the current one.
  • Your insurance company may not cover all costs. Be sure to talk to your insurance company and one of the clinical trial coordinators so you know exactly what you’ll have to pay for before you agree to be part of a clinical trial.
  • Because you’ll be closely monitored, you may have to undergo testing more often than you would if you weren’t in the trial. This could mean more time in the doctor’s office or hospital.


Phases of trials

All phases in clinical trials are governed by strict protocols, and are overseen by many regulatory bodies, from the Food and Drug Administration (FDA) to Institutional Review Boards (IRBs). IRBs are a group of independent doctors, nurses, social workers, ethicists, lawyers and patients who review protocols, monitor trials closely and make sure patients are protected.

The phases of a clinical trial are as follows:

Phase I helps determine the optimal amount or dose of a new therapy that can be given safely to participants. These studies typically have a small number of participants, often fewer than 20.

Phase II continues to evaluate safety, but also begins to assess a therapy’s effectiveness. In Phase II the aim is to test the new drug in a larger group of people to better measure safety, effectiveness and side effects.

Phase III: in this phase, researchers compare the effectiveness of a new therapy with a standard treatment. Phase III may include hundreds or thousands of participants. It provides a better test of whether new treatments work better than existing treatments, and firmer evidence about how common and serious any side effects are.

Phase IV continues to study the safety and effectiveness of a treatment after the FDA approves it.


Your doctor may offer you a clinical trial as a treatment option.

As a patient, you make the decision if you want to take part in a clinical trial. The choice is very personal and depends on your unique situation.

As with any treatment, you and your doctor need to weigh the benefits against the risks and decide what’s best for you. Ask as many questions as you need to make sure you are comfortable with your decision.

All patients in clinical trials are volunteers, which means you can “quit” the trial at any time. Make sure you discuss your decision with your doctor first to make sure leaving the trial won’t affect your health, and to determine what other treatment options are available.

Hundreds of thousands of people have been helped and are alive today because other people chose to participate in a trial that resulted in a new, more effective treatment.

Participating in clinical studies gives us optimism for today and promise for the future.

Nearly 4,000 experimental drug therapies are in active clinical trials today, and that number will continue to grow as improvements are made in detecting disease, in understanding the root causes of acute and chronic illnesses, and in discovering medical innovations.  

As part of the mission to eliminate cancer, Comprehensive Breast Care surgeons are involved with numerous clinical trials designed to test new treatments. Our team is committed to providing our patients with access to as many clinical trials as possible. These trials are critical in our continuing quest for the best and most appropriate options for our patients.

Visit our website to review the clinical trials now underway.

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