Clinical Trials Information for Patients and Families

What Is a Clinical Trial?

A clinical trial is a research study involving volunteers that is designed to answer a specific question, such as "Does this new treatment work better than the usual treatment?"

Treatments might be new drugs or new combinations of drugs, new surgical procedures or devices, or new ways to use existing treatments.

The goal of clinical trials is to determine if a new test or treatment works and is safe. Clinical trials can also look at other aspects of care, such as improving the quality of life for people with chronic illnesses.

Clinical Trials are Important

Carefully conducted clinical trials are the safest and fastest way to find new approaches that may prevent, detect, or treat health problems, or improve the health of the people in our communities.

Many treatments that are now standard were first shown to be effective in clinical trials.

Clinical Trials Are Not Treatment

When you visit your doctor, he or she diagnoses and treats your current illness or condition. A clinical trial may or may not help you personally. It is a research study designed to answer a specific question. Clinical trial volunteers agree to participate in the study to help answer the study question.

Clinical Trials Process

Clinical trials are part of a long, careful process which may take many years. The process of testing new treatments involves 3 to 4 steps, called phases. Each phase has a different purpose and helps researchers answer different questions.

• Phase I
  Researchers test an experimental drug or treatment in a small group of people (20–80) for the first time. The purpose is to evaluate its safety and identify side effects.
• Phase II
  The experimental drug or treatment is administered to a larger group of people (100–300) to determine its effectiveness and to further evaluate its safety.
• Phase III
  The experimental drug or treatment is administered to large groups of people (1,000–3,000) to confirm its effectiveness, monitor side effects, compare it with standard or equivalent treatments, and collect information that will allow the experimental drug or treatment to be used safely.
• Phase IV
  After a drug is approved by the FDA and made available to the public, researchers track its safety, seeking more information about a drug or treatment’s risks, benefits, and optimal use.

Who Pays For Clinical Trials?

Clinical trials can be funded by pharmaceutical companies, academic medical centers, voluntary groups and other organizations, and federal agencies such as the National Institutes of Health, the U.S. Department of Defense, and the U.S. Department of Veterans Affairs. Physicians, health care providers, and other individuals can also sponsor clinical research.

Financial Conflict of Interest

Anyone in the community can ask whether a researcher who has a key role on a research project that receives funding from a Public Health Service agency has a financial conflict of interest, and if so, how Baystate is managing the conflict to make sure that it does not affect the research. Baystate will send a response within 5 business days of receiving a request.

A written request must be sent via first-class mail to:
Attn: Designated Institutional Official
Office of Research
3601 Main Street, 3rd Floor
Springfield, MA 01107

or via email to FCOI@baystatehealth.org

Volunteering is your choice

You have no obligation to participate in a clinical trial, and after enrolling in a study, you may leave at any time for any reason.

Before you do Volunteer, Consider Carefully Whether being a Volunteer is Right for you.

• Know what you are getting into
• Understand the pros and cons
• Ask questions
• Learn as much as you can

Am I able to Participate?

Not all clinical trials are right for all patients. So researchers follow strict guidelines about who may join a clinical trial. These rules are called eligibility criteria. They protect volunteers from enrolling in studies that may harm them, and ensure that the results of the trial will reflect the treatment being studied, rather than outside factors. Eligibility criteria include information about you and your overall health:

• Age and gender
• Results of medical tests
• Medicines that you are taking
• Any other health problems

What are the Benefits and Risks of being in a Clinical Trial?

You may or may not receive health benefits from participating in a clinical trial, but there are risks involved, too. You may benefit from joining a clinical trial in one of the following ways:

• Access to potential new treatments before they are available to the general public.
• Play an active role in your health care.
• Get regular and careful medical attention from the research team.
• Help future patients by contributing to medical research.

When weighing risks, consider the degree of harm and the chance of harm occurring. Some possible risks include:

• Unpleasant or serious side effects from the experimental treatment.
• The experimental treatment may not be better than, or as good as, standard treatment.
• The study may require more time and attention than standard treatment would, including visits to the study site, more blood tests, more treatments, hospital stays, or complex dosage requirements.
  
  

Bill of Rights

Baystate Health's most important commitment is to our patients. We conduct research in a way that protects the safety, well-being, and rights of our research volunteers. Download our Research Participant's Bill of Rights.

Safety and Ethical Review

All research involving people must meet ethical standards. Research activities at Baystate that involve people are watched by our fully-accredited Human Research Protection Program to make sure that the research is safe and ethical. No research involving people may be started until is has been reviewed and approved by the Institutional Review Board (IRB). The IRB is a group of volunteers that includes doctors and other health professionals, as well as people from our surrounding community.

Find out if a Researcher Has a Financial Conflict of Interest

Anyone in the community can ask whether a researcher who has a key role on a research project that receives funding from a Public Health Service agency has a financial conflict of interest. If there is one, Baystate will tell you how it is managing the conflict to make sure that it does not affect the research. Baystate will send a response within 5 business days of receiving a request.

A written request must be sent via first-class mail to:
Attn: Designated Institutional Official
Office of Research
3601 Main Street, 3rd Floor
Springfield, MA 01107

or via email to FCOI@baystatehealth.org

Informed Consent

Members of the research team will explain the details of the study. Information about the purpose, requirements, duration, and potential risks and benefits will be included in the informed consent document that will be reviewed with you before you can participate in a study. You can drop out of the study or refuse particular treatments or tests at any time.

Questions to ask Before You Join a Clinical Trial

• What is the main purpose of this trial?
• Who will fund the study?
• How long will the study last?
• What will be my responsibilities if I participate?
• What are the possible short- and long-term benefits, side effects and risks to me?
• What other options do people with my condition have?
• How do the risks and benefits of this trial compare with those options?
• What kind of treatments, procedures or tests will I have during the trial?
• How do they compare with those I would have outside the trial?
• Can I take my regular medications during the trial?
• What happens if I get sick while participating in the trial?
• Where will I get my medical care?
• Can I still see my regular doctor?
• Who will be in charge of my care?
• Can I remain on this treatment when the study is over?
• How could being in this study affect my daily life?
• Will I have to pay for any part of the trial? If so, what are the charges likely to be?
• What is my health insurance likely to cover

• Baystate Medical Center's Research Subject Advocacy fact sheet
  This fact sheet describes how Baystate's HRPP functions as an advocate for research subjects.
• National Institute of Health's ClinicalTrials.gov
  ClinicalTrials.gov is a website that provides easy access to information about clinical studies on a wide range of diseases and conditions.
• National Institute of Health's NIH Clinical Research Trials and You
  A list of registries, patient stories, and resources for parents and children.
• The Role of Accreditation
  The Association for the Accreditation of Human Research Protection Programs explains why accreditation is important to research volunteers.
• Children and Clinical Studies
• The Center for Information & Study on Clinical Research Participation (CISCRP)