Patients

Every single cancer treatment we have today was once a clinical trial. If more people participated in clinical trials, we could cut the wait for new therapies to be approved in half, making them available faster.

Clinical trials gave us chemotherapies, hormonal therapies (This therapy – also called hormone treatment or endocrine therapy - slows or stops the growth of cancer using hormones. Credit: National Cancer Institute), new techniques and dosing guidelines for radiation therapy, targeted therapies (targets proteins that control how cancer cells grow, divide and spread) new surgical techniques and devices, immunotherapy (helps your immune system fight cancer as it would other infections and diseases), and combinations of these therapies. Clinical trials have also shown us how to better manage side effects from cancer or its treatment.

Did you know?


Only about 7 percent of adults with cancer will participate in a clinical trial, even though studies show those who do said they:

  • Would recommend it to others

  • Were treated with dignity

  • Would do again

  • Felt it was worth it

(Sources: Journal of Clinical Oncology, 2011; Coalition of Cancer Cooperative Groups, 2009)


Breakthrough research

At the Hartford HealthCare Cancer Institute (HHCCI), we recognize the value of research and education and integrate clinical trials into the high-quality care we provide. We offer many types of studies, including those designed to fight cancer, improve quality of life, provide supportive care, and study changes in blood, urine or tissue specimens to better understand cancer biology.

Many clinical trials seek to provide a better patient experience while advancing knowledge. As a charter member of the Memorial Sloan Kettering Cancer Alliance, HHCCI brings Connecticut patients direct access to world-renowned clinical research trials, allowing us to offer tomorrow’s most promising treatments today.


Clinical trials and YOU

Participating in a clinical trial could help you today or others in the future. If you learn about clinical trials early in your cancer journey, even at diagnosis, more opportunities may be available. Even a trial that’s not appropriate now might be a good option in the future. While deciding whether to join a clinical trial is a personal decision, you can ask your doctor or nurse for more information and options that may be right for you.


Easier than ever

It is important to test drugs and medical products in the people they are meant to help. To do that, we need volunteers of all genders, ethnicities, races, education levels, sexual orientations and religions to enroll in clinical trials. The HHCCI is committed to reducing barriers to research participation across Connecticut.

While studies vary, we can often offer:

  • Remote consenting of new and ongoing patients
  • Virtual office visits
  • Shipping oral study medications to patient homes
  • Interpreter services for visits and translated materials

Other resources like transportation, counseling and nutrition can help make it easier to participate.

Talk to a nurse navigator to learn more


Common Questions

At Hartford HealthCare, we encourage curiosity.

We’ve answered some common questions about the clinical trial process, safety and participation here, but we encourage you to ask questions others of your provider or our research team.


What are clinical trials?

Clinical trials are studies of new drugs, procedures and treatments in people. Doctors use clinical trials to develop new treatments for serious diseases such as cancer. Most standard treatments given today were developed from a clinical trial. Like all options, clinical trials have possible benefits and risks.

Clinical trials are the final step in a long process that begins with research in a lab. Before any new treatment is used with people in clinical trials, researchers work for many years to understand its effects in the lab and animals. They also try to figure out any side effects it may cause.

Any time you or a loved one needs treatment for cancer, clinical trials are an option. Trials are available for all stages of cancer. It is a myth that they are only for people with advanced cancer not responding to treatment.

Clinical trials offered at Hartford HealthCare

A clinical trial/study follows a research plan called a protocol. The protocol is designed to answer specific questions and safeguard the health of participants. It includes:

  • The reason for the study
  • Who may participate in the study (eligibility criteria)
  • The number of participants needed
  • The schedule of tests, procedures or drugs and their dosages
  • The study length
  • The information to be gathered about participants

How do we protect people in clinical trials?

There are several safeguards in place to help protect people participating in clinical trials. While there are risks involved with any study, the safeguards reduce the risk as much as possible. These groups also review all clinical trials to make sure participants are protected:

Institutional Review Boards (IRBs)

IRBs make sure people in clinical trials are protected and federal laws are followed. In turn, the federal Office of Human Research Protections makes sure IRBs follow the laws directing their process. These laws and regulations ensure patient safety is the priority. Before starting at trial, researchers must have the IRB review the protocol, which describes the study in detail. The IRB decides if the study looks at a worthwhile question and ensures participant safety. The IRB also makes sure the informed consent form people sign before entering a trial is accurate, complete and easy to understand. Once a clinical trial begins, the IRB watches for problems. Anyone participating in a clinical trial can always contact the IRB with questions or concerns.

The physician investigator

The physician investigator – also called a principal investigator or PI - is in charge of all parts of a clinical trial but may work closely with your physician to manage your care while you are on a clinical trial. The PI holds the main responsibility for patient safety in a clinical trial, monitoring patients closely and sharing new safety information with them as soon as possible. The care team also includes a research coordinator or nurse to help ensure the study is conducted according to plan and you are closely monitored while participating.

Government agencies

Government agencies like the Office of Human Research Protection, Food and Drug Administration and National Cancer Institute provide oversight and protection for patients participating in clinical trials.


What can I expect if I join a clinical trial?

If you and your doctor decide a specific clinical trial is the right option, you will:

  1. Learn all about the trial, the risks and benefits. When you’re ready, you sign an informed consent giving your permission to participate.
  2. You will then be screened to confirm it is safe for you to take part. Each study has specific guidelines called inclusion/exclusion criteria for deciding who can participate. This includes reviewing your medical history to understand past and current medical conditions, treatment history, stage of disease and basic demographic information. Screening can take two to four weeks and might involve diagnostic imaging, labs, EKGs and other tests.
  3. If the screening shows you are a candidate for the trial, you will get the treatment/intervention. The research team will work with you throughout treatment and long-term follow-up.
  4. You can choose to withdraw from a study at any time, even if it is not over.

Ask your doctor or nurse if you have any questions or you’d like to learn more about clinical trials that might be right for you. You can speak to a member of our research team by calling 860.972.4700.


What types of clinical trials are there?

Treatment trials

In our search for more effective ways to treat cancer, these trials test new drugs, vaccines, surgical approaches or radiation therapy, and combinations of treatments. These trials look at how the new treatment works as compared with existing treatment, as well as any side effects.

Prevention trials

Examining a person’s risk for developing cancer – and ways to reduce that risk – are the focus of these trials. Those who participate are generally at high risk for cancer or have had one form and are at risk for developing a different form.

Screening trials

Understanding that cancer is more treatable when it is discovered early, these trials test new ways to screen and find the disease.

Quality of life/palliative care trials

The side effects from cancer and the treatments for it can impact a patient’s quality of life. These trials examine ways to help such side effects as pain, nausea and resulting nutrition problems, infection, trouble sleeping and depression.


What are the phases of clinical trials?3

All clinical trials progress through stages from the time they open to enrollment to the time the researchers are ready to present the resulting data. Phases include:

  • Phase 0. The first clinical trials done among people, these aim to determine how the body processes a drug and how the drug affects the body. A very small dose of drug is given to about 10 to 15 people in these trials.
  • Phase I. The goal here is to determine the best dose – with fewest side effects - of a new drug. The drug is tested in 15 to 30 patients and, if it is found to be safe enough, it can be tested in a Phase II clinical trial.
  • Phase II. A deeper look at the safety of the drug, as well as whether it works in the disease of interest, is the focus at Phase II. These trials are done in larger groups and, often, involve new combinations of drugs. Participants - who usually get the same dose, but can be randomly assigned to different treatment groups which are given different doses or different methods of the treatment to see which yields the best balance of safety and response - are closely watched to see if the drug works.3 Placebos, or inactive treatments, are not used in Phase II trials. Every Phase II study participant is watched closely and the study will be stopped early if side effects of the new drug are too severe or if one group has much better results. Phase III clinical trials are often needed before the FDA will approve a new drug for the general public.
  • Phase III. These compare a new drug to the standard treatment, evaluating side effects of each and which works better. Phase III trials enroll 100 or more people. They are often randomized, which means participants are put into treatment groups, called trial arms, by chance.3 When possible, neither doctors nor participants know which treatments they are getting. This is called a double-blind study. Placebos may be used in some Phase III studies, but they’re never alone if there’s an available treatment that works.
  • Phase IV. Once FDA approved, new drugs are monitored in hundreds or thousands of patients through Phase IV trials. This allows for better research on short-lived and long-lasting side effects and safety. For example, some rare side effects may only be found in large groups of people. Doctors can also learn more about how the drug works and if it’s helpful used with other treatments.

Are there risks?

Yes, all clinical trials have risks. But, any medical test, treatment or procedure has risks. The risk may be higher in a clinical trial because there are more unknowns. This is especially true of Phase I and II trials, where the treatment has been studied in fewer people.

Think, however, if the possible benefits outweigh the risks. People with cancer are often willing to accept a certain amount of risk for a chance to be helped. Talk to your doctor about the possible benefits and decide if the chance of help is worth the risk.

Before Joining a Clinical Trial

Questions to ask before joining a clinical trial

Clinical trials test new drugs and techniques for diagnosing and treating cancer of all types before they are approved and available to the general public for use. Participating in a clinical trial might be a good opportunity for you to access therapies in your cancer journey, but all trials have benefits and risks. Before you decide to join one, we suggest you ask any or all of these questions of your healthcare provider. It’s important that you understand the trial and feel comfortable participating.

You can print this list and take notes directly on it, or ask a friend/family member to jot down information so you can listen fully.

  • What phase is this clinical trial in?
  • Why is this study being done?
  • How long do I have to decide about joining?
  • What will happen if I decide to take part - or not - in this clinical trial?
  • Will the researchers work with my cancer doctor? Who will be in charge of my care?
  • Who will I contact if I have problems, questions or concerns?
  • What are my other options and the pros and cons of each?
  • How much do you know about this treatment and clinical trials in general?
  • In past studies of this treatment, what were the results? Do they apply to me?
  • Is there anything I can read about this clinical trial?
  • What treatments and tests would I need to have, and how often?
  • Would I need to plan on extra time or travel?
  • What side effects might I expect and how do they compare to those from standard care for my cancer? Are there other risks?
  • How will we know if the treatment is working?
  • Will I need to be in the hospital for any part of the trial? If so, how often, for how long and who will pay for it?
  • Will I still see my regular cancer doctor?
  • Will I have to pay for anything? Will my insurance cover the treatment?
  • If I am harmed as a result of the research, what treatment will I be entitled to?
  • How long will the clinical trial last?
  • Will I be able to work during the clinical trial?
  • Are there reasons I could be removed from the clinical trial or that the clinical trial might stop early?
  • Is long-term follow-up care part of the trial? What would it involve?
  • If the treatment is working for me, can I keep getting it even after the clinical trial ends?
  • Can I talk to other people taking part in the clinical trial?
  • Will I be able to find out about the results of the clinical trial?

Print the Questions

Find a Clinical Trial

The Hartford HealthCare Cancer Institute has about 50 studies available to cancer patients at any time. You can view the latest clinical trials offered here or contact the research staff at CancerResearchSupport@hhchealth.org or 860.972.4700.

To view available clinical trials across the nation that are currently recruiting volunteers to participate visit the federal database on clinicaltrials.gov.

Next Generation Sequencing

At Hartford HealthCare, all tumors can be profiled with a novel test called MSK-IMPACT.

Tumor profiling uses a lab test to check a sample of tumor tissue for certain genes or genetic mutations, proteins or other biomarkers. Tumor profiling may be used to help plan treatment and predict whether cancer will come back or spread to other parts of the body.

MSK-IMPACT – which uses cutting-edge, next-generation DNA-sequencing technology - can test any tumor, no matter where the cancer started. MSK-IMPACT screens for 468 genes chosen because they play a critical role in tumor development and behavior. Many new drugs target specific genes and MSK-IMPACT can help us match you to the best standard treatment or clinical trial. Ask your doctor how you can learn more about MSK-IMPACT.

More Resources

Health insurance coverage

Several federal regulations promote greater access to clinical trials for all diseases, specifically access to new treatments.

The Affordable Care Act requires private insurers cover routine patient costs associated with participation in approved clinical trials. Similarly, the CMS National Coverage Determination passed in 2000 covers routine care for Medicare beneficiaries taking part in qualifying clinical trials. Most states, including Connecticut, have laws or cooperative agreements requiring private insurers to cover routine patient costs associated with clinical trials. In all state and federal regulations, the investigational drug/device is excluded from coverage. Learn more here.

Check with your insurance provider and talk with the clinical trial research team about coverage.

Clinical trials: What you need to know – American Cancer Society

A national, community-based voluntary health organization, the American Cancer Society funds and conducts research, shares expert information and provides education and support to cancer patients.

Clinical trials information – National Cancer Institute (NCI)

The NCI is a federal agency that drives cancer research and advances scientific knowledge by supporting and training researchers, funding research and coordinating the National Cancer Plan to help people live longer, healthier lives.


Cancer Research & Clinical Trials

Hartford HealthCare Cancer Institute


Clinical Trial Referrals