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:
- Learn all about the trial, the risks and benefits. When you’re ready, you sign an informed consent giving your permission to participate.
- 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.
- 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.
- 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.