Becoming a Participant in a Clinical Trial

Participating in a clinical trial may offer you access to a new treatment that may or may not be better than those that are already available. Results from previous clinical trials have led to important discoveries that make our lives better – such as new drugs to treat cancer and diabetes, vaccines, ways to stop smoking, and improved medical procedures.

You may have already heard or read about a clinical trial at Lahey Hospital & Medical Center and want to learn more about it, or you may just be starting to explore this option. In either case, there is a full list of clinical trials at Lahey Hospital & Medical Center that are currently recruiting for new participants.

It's your decision

Before you decide to become a participant in a research study, you need to gather information:

• Know what you are getting into
• Ask questions – lots of them
• Learn as much as you can
• Know the pros and cons of participating

How do I learn more?

Before signing up for a study, find out as much as you can about it. Every study being done at Lahey Hospital & Medical Center has a contact person. Get in touch with that person and ask for details about the study. You should receive information such as:

• A description of the purpose of the study
• The name of the study sponsor
• Specific details about who is eligible to participate
• The length of the study
• What procedures, appointments and tests are required as part of the study

Who can participate in a clinical trial?

Clinical trials have specific guidelines that define who can and who can not participate. Some studies seek participants who have the illness or condition being studied. Others enroll healthy participants. And, some studies are limited to a pre-determined group of people who are asked by researchers to enroll.

The factors that allow someone to participate in a study are called ‘inclusion criteria’ and the factors that disqualify someone from participating are called ‘exclusion criteria’. Some examples of such criteria are age, gender, type of disease, previous treatment history, or other medical conditions. The contact person or study coordinator for a particular study will help determine whether or not you are eligible for participation.

What questions should I ask?

We have created a page of frequently asked questions that apply to general clinical research. If you are considering a particular clinical trial, here are some suggestions of questions you might want to ask the study team:

• What is the study trying to find out?
• What kinds of tests and exams will I have while I’m in the study? How much time will each one take? What is involved with each one?
• Has this drug/device/procedure been tested before? What information was learned?
• Will everyone on the study receive the same treatment? If not, how will it be determined which treatment I will receive?
• How often will I need to see the doctor and/or come to the hospital?
• Will participating cost me anything? Will my health insurance pay for it?
• What side effects can I expect from the treatment being tested? How do they compare with the side effects of standard (non-study) treatment?
• What other options do I have? Are there other treatment options I should consider?
• How long will the study last? What will happen at the end of the study?

If you have specific questions or concerns, contact the research coordinator or study contact for that study. Also talk over your decision with your primary care physician and your family or friends.

How do I join a particular study?

To become a participant, follow these steps:

1. Call or email the study coordinator or contact person.
2. Set up an appointment to meet with the doctor in charge of the study, or with other members of the study team.
3. If required, take additional tests to determine if you are eligible to participate.
4. If you are eligible, meet with the doctor in charge of the study and sign a special agreement called an “Informed Consent” form. This document shows that you have been given all complete information about the study and you understand it. The Informed Consent form is NOT a contract – you can leave the study at any time, for any reason.
5. Set up an appointment schedule with the study coordinator, who will be your guide throughout your time on study.

Important points to remember:

• Clinical trials are tests of medical treatments – drugs, devices, or procedures – to see if they are safe and if they work.
• Before you agree to take part in a study you must be given complete information about the study.
• You should ask lots of questions to be sure you understand the study.
• You must sign an Informed Consent document before taking part in the study.