What is a clinical trial?
A clinical trial (also called clinical research) is a research study in human volunteers to answer specific health questions. Carefully conducted clinical trials are the fastest and safest ways to find treatments that work in people and ways to improve health. Interventional trials determine whether experimental treatments or new ways of using known therapies are safe and effective under controlled environments. Observational trials address health issues in large groups of people or populations in natural settings. (Answer courtesy of U.S. National Library of Medicine)
What is informed consent?
Informed consent is a process during which you learn key facts about a study before you decide whether or not to participate.
Your participation in any clinical trial is voluntary. Before you volunteer to participate, you will receive an informed consent document. This document explains the details of the study, including information about the study approach and tests you may have, the potential risks and benefits, as well as your rights and responsibilities.
A member of the research team will discuss the study with you and answer your questions so you can make an informed decision about whether or not to participate. In addition, you have the right to ask questions throughout the course of the study and may withdraw consent (stop) at any time.
Since the decision to volunteer for a clinical trial is a personal one, you should decide in close consultation of your health care provider, family members, and friends. (Answer courtesy of U.S. National Library of Medicine)
Who pays for clinical trials?
Funding for clinical trials comes from many sources including the federal government, National Institutes of Health and private industries (such as drug makers/pharmaceutical companies or technology companies).
Will I be paid if I decide to participate?
Maybe. Payment depends on the particular study. You may or may not receive a small stipend, depending on what is involved in the study. Some studies compensate travel expenses and/or parking.
Will my health insurance cover the cost of my care?
Private health insurance may not cover the medical care costs associated with a clinical trial. This is especially true if the trial is considered to be experimental or investigational. Check with your health insurance provider for more information.
As you think about taking part in a clinical trial, you will face the issue of how to cover the costs of medical care. Even if you have health insurance, your plan may not cover all of the costs related to receiving treatment in a clinical trial.
There are two types of costs associated with a clinical trial, routine patient care costs and research costs:
1. Routine patient care costs are those costs related to standard medical care. These costs are often covered by health insurance.
2. Research costs are those costs related to medical care that is provided solely for the purpose of conducting the trial. Often these costs are not covered by health insurance, but they may be covered by the trial’s sponsor.
When you take part in a clinical trial, it is possible that you may have extra doctor visits that you would not have with standard medical care. These extra visits may also add to your costs for transportation and child care.
Do I have to be a Lahey Health patient in order to participate?
No, you do not have to be a current Lahey Health patient in order to participate in a research study here. Anyone fitting the eligibility criteria can be accepted into a clinical trial, regardless of where you typically receive your medical care.
Do all of the trial-required procedures and tests need to be done at Lahey?
Usually, we prefer you to have any tests associated with the trial performed at Lahey. This makes it easier and more efficient to track results and maintain test accuracy in the study. However, if you have certain tests/procedures done at another hospital or physician’s office, we may use those results if they were done within the timeframe specified per protocol.
What is an Institutional Review Board (IRB)?
An IRB is a group that reviews and monitors research involving human subjects. The primary responsibility of this group is to protect the rights and welfare of research subjects who participate in research studies. An IRB is made up of a diverse group of individuals; including physicians, other health care providers, and lay members of the community. The IRB reviews plans for research studies before participants can be enrolled.
What are the benefits of participating? Are there any risks?
There are both benefits and risks associated with clinical trials. By participating in a clinical trial, you may benefit by:
• Gaining access to new treatments that are not yet available to the public
• Obtaining expert medical care at a leading health care facility
• Playing an active role in your own health care
• Helping others by contributing to medical research
Clinical trials may also have risks:
• There may be unpleasant, serious or even life-threatening side effects from treatment
• Treatment may not be effective for some individuals
• The study may require a lot of time for traveling to the study site, receiving treatments, or hospital stays
• Health insurance may not cover all the study costs
Risks are variable, depending on the type of study. A doctor, nurse, or other member of the study team will explain all the risks of the study to you before your participation begins.
Who can I contact if I have questions about the study?
If you have questions prior to enrolling in a study, you should contact the research coordinator for that study. A list of trials and the responsible research coordinator can be found here.
During the informed consent process you will be given the name and contact information of the doctor responsible for the study. If you have any questions concerning the study, the availability of medical care, or if you have experienced a research-related illness, injury or emergency, you should contact the doctor at the phone number provided in your copy of the consent form.
If you have any questions about your rights as a research subject, you may contact the Office of Research Administration at 781.744.8027.
What if I start the study and then change my mind about participating?
Your participation in a clinical trial is always voluntary. Therefore you may leave it at any time – either before the study starts or at any time during the study or the follow-up period. If you do decide to leave a study before it ends, please contact the study coordinator about your decision as soon as possible, in case withdrawal from the study could affect your health in any way.
What about my own doctor? Will you let him/her know I'm participating in a study? Do I still need to see him/her while I'm on study?
We will inform your doctor if you decide to participate in a study, but we will not keep him/her updated on a regular basis. It is important that you continue ongoing care and communication with your primary physician while you participate in a study.
How can I find out if I'm eligible for a specific study?
All clinical trials have guidelines about who can participate in a study. Guidelines are based on such factors as age, type of disease, medical history, and current medical condition. Some research studies seek volunteers with illnesses or conditions to be studied, while other trials need healthy volunteers.
Factors that allow you to participate in a study are called "inclusion criteria". Factors that keep you from participating are called "exclusion criteria". The criteria are not used to reject people for any personal reason, but rather are used to identify appropriate participants and keep them safe. The criteria also help researchers ensure they will be able to answer the questions they plan to study.
The list of research studies currently available at Lahey Hospital & Medical Center is updated regularly. Contact the study coordinator listed for an individual study in order to learn more about the criteria that apply to that study.
Who can I contact for more information about clinical research at Lahey?
For general questions about research at Lahey Hospital & Medical Center, contact the Office of Research Administration at 781.744.8027. For questions about a specific study, contact the study coordinator for that study. A list of research studies currently enrolling at Lahey Hospital & Medical Center is updated regularly.