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Clinical Trials

When you have cancer, you don’t just want any treatment — you want the most advanced treatment available.

The Baystate Regional Cancer Program has an active clinical research program that includes access to the latest treatment options through clinical trials.

Clinical research is a critical factor in our ability to discover new treatments and improve care. We believe your best cancer treatment option is a clinical trial, and we encourage you to explore this option with your cancer care team.

Partnering with the Best

Our active clinical research program includes affiliations with National Cancer Institute-sponsored cooperative research organizations such as:

  • Children's Oncology Group (COG)
  • Gynecologic Oncology Group
  • Eastern Cooperative Oncology Group (ECOG)
  • National Surgical Adjuvant Bowel and Breast Project (NSABP)
  • Radiation Therapy Oncology Group (RTOG)

In addition, our own cancer experts are consistently looking for novel approaches to cancer care and investigating clinical trials of new cancer agents. We also conduct research into our past performance through our active tumor registry. In this way, we continue to monitor our own quality and ensure the best possible outcomes for future patients.

Learn More About Clinical Trials

Clinical trials test ways to treat and prevent cancer. All of today’s standard cancer treatments are a result of clinical trials completed many years ago.

If you are considering volunteering for a clinical trial, you will likely have many questions, including:

How are clinical trials conducted?

More than 25,000 cancer patients enroll in clinical trials each year through the National Cancer Institute. Many more patients are enrolled in clinical trials sponsored by other groups.

Clinical trials testing new treatments are carried out in phases.

Phase I — Is the Treatment Safe?

Doctors gather information about the side effects of the treatment and decide on the safe dose. Only a few patients in a few places take part in a Phase I trial.

Phase II — Does the Treatment Work?

In this step, doctors test the treatment to see how well it works. Most of the time, fewer than 100 patients are involved in Phase II trials.

Phase III — Is the Treatment Better?

Phase III trials compare the new treatment against the current standard therapy and randomly assign patients into one of the two groups. Many people from all over the country take part in these trials.

Phase IV — Are There Better Ways to Use the Treatment?

In this final step, treatments are tested to make sure they are safe and work well over a long period of time. This phase most often occurs once the new treatment has been approved for standard use. Anywhere from several hundred to several thousand people are enrolled in a Phase IV trial.

How do I participate in a clinical trial?

Each clinical trial calls for certain criteria that you must meet to be included in that trial, such as:

  • Age
  • Current health
  • Gender
  • Medical history
  • Stage of cancer
  • Type of cancer

It's important to remember that clinical trials are completely voluntary.  You can leave a trial at any time.

Before you enroll in a trial, you will need to know:

  • What is the purpose of the study?
  • What treatment will be given?
  • What tests will be taken?
  • What are the benefits and risk?
  • Has the trial been approved by an Institutional Review Board?

Once you have the answers to these questions, you will be asked for informed consent. Informed consent is your written consent that you understand the answers to the above questions and agree to take part.

Join a Clinical Trial

If you are interested in joining a clinical trial, talk to your doctor. He or she can help you find out if a trial is right for you. Information on current trials can be found through the National Cancer Institute [Call 1-800-4-CANCER or visit to learn more.


What are the benefits and risks of participating in a clinical trial?

Benefits to Participating?

  • Access to promising new treatments that are not available outside of the clinical trial setting.
  • The treatment being studied may be better than the standard approach.
  • You are followed very closely by a research team made up of doctors and other health professionals.
  • You may be the first to benefit from the new method.Results from the study may help others in the future.

 

Risks of Participating

  • New drugs or treatments may not be any better than the standard care they are being compared to.
  • New treatments may have side effects that are not expected.
  • If you are in a randomized trial, you will not be able to choose if you are getting the new treatment or the standard approach.
  • Health insurance may not cover all your costs.
  • You may be required to make more frequent visits to the doctor.

 

What questions should I ask my doctor about clinical trials?

Before joining a clinical trial, you may want to ask your doctor questions about the study and your treatment.

 

  • What are you trying to learn from the study?
  • What do doctors know already about the treatments being studied?
  • What treatments and tests will I get during this trial?
  • Who will be in charge of my care during the study?
  • What are the differences between what I would get on this treatment and the standard treatment you would recommend?
  • What are the benefits and risks?
  • How will this affect my daily life?
  • How long will the study last?
  • What will I be asked to pay?
  • How will I know if the study was successful?

What types of clinical trials are available?

Clinical trials fall into one of several categories, including:

Prevention

These trials test new approaches that doctors believe may reduce your chance of developing cancer. Most involve healthy people who have not had cancer. Some studies are conducted with people who have had cancer in the past to try to find ways to prevent second cancers.

Screening

Since cancer is often easier to cure when it is found early, screening trials test methods to better detect cancer, especially in the early stages. These studies also help find out whether finding cancer before it causes symptoms will lessen a patient's chances of dying from the disease.

Diagnostic

Diagnostic trials help answer whether or not there are new approaches that could be used to find certain types of cancer and at an earlier stage.

Treatment

The purpose of these trials is to find out if a new treatment or technique is better than the standard treatment. This can include new approaches to radiation therapy, new drugs, vaccines, and different combinations of treatment.

Supportive Care/Quality of Life

These studies explore ways to improve the comfort and quality of life of people with cancer or survivors. These trials also study ways to better combat the side effects of some treatments.

Genetics Studies

These are generally done with another clinical trial and focus on how genetic makeup can affect detection, diagnosis, or response to cancer treatment.

Who organizes a clinical trial?

Organizations or individuals looking for better treatments for cancer or new ways to prevent or detect cancer organize clinical trials. Each trial has a person in charge, usually a doctor, who is called the protocol chair or principal investigator.

 

Sponsors of clinical trials may include:

  • Drug manufacturers
  • Groups like the American Cancer Society
  • Individual doctors at cancer centers or other medical institutions
  • Technology companies National Cancer Institute

Who pays for a clinical trial?

Most clinical trials are provided at no cost to you, however you will want to be sure of the details, including:

  • Is the study completely covered by a sponsor, such as the government, drug manufacturer, or technology company?
  • Will the sponsor pay for any special testing or extra doctor visits?
  • Will the sponsor pay for any travel time or mileage expenses?

Insurance Questions

  • If you have private insurance, it may pay for some or all of the costs of your treatment. Check with your provider.
  • Medicare will pay for the routine costs for some government-sponsored clinical trials. Ask your doctor or call your local Medicare provider to find out what Medicare will pay for your treatment.