Clinical Trials

There are several types of clinical research studies.

• Treatment trials test new treatments, new combinations of drugs, or new approaches to surgery or radiation therapy.
• Diagnostic trials determine better tests or procedures for diagnosing a particular disease or condition.
• Cancer trials test how cancer forms and grows to develop more targeted treatment options that have a higher chance of success.
• Prevention trials look for better ways to prevent a disease in people who have never had the disease or to prevent the disease from recurring.
• Quality of life trials explore and measure ways to improve the comfort and quality of life of people with a chronic illness.
• Screening trials test the best way to detect certain diseases or health conditions.
• Cost-effectiveness studies compare interventions in terms of their costs and health effects and assess how much value the interventions provide.
• Outcomes research seeks to understand the end results of particular health care practices and interventions in order to monitor and improve the quality of care. These types of studies are performed by investigators in our Comparative Effectiveness Research Institute (CERI).

There are various phases of clinical trials, including Pre-Clinical, Phase I, Phase II, Phase III and Phase IV.

• Preclinical trials are referred to as "non-human" trials and include in vitro (test tube or culture) and in vivo (animal) experiments. This type of research is generally conducted in a laboratory using animals such as rodents, rabbits and monkeys. Preclinical trials are performed in order to obtain preliminary information on a drug or treatment's effectiveness. If a drug is believed to be potentially effective, a Phase I trial may be initiated.
• Phase I trials are the first studies done with human subjects. These trials are generally conducted on a small group of patients (up to 100) and are conducted to look at safety and risks of a study drug or treatment or dose ranges. Subjects are generally considered "healthy volunteers" and are monitored closely.
• Phase II trials are conducted to determine effects on the treatment of disease. These trials are generally conducted on a larger group of patients (up to 300) and looks at how the drug works. Phase II studies can be divided by Phase IIA and Phase II B. Phase IIA studies typically look at dosing or how much of a drug to give. Phase IIB looks at how the drug works.
• Phase III trials compare the new treatment with the available standard treatment to see which one is more effective or compares the new treatment to a placebo (inactive substances). These trials are much larger in scale and are conducted at multiple centers with hundreds to thousands of patients. They are typically conducted as "randomized, double-blind and controlled" trials, used as the gold standard for the industry. In these trials placebos or inactive substances are typically used along with the study medication. Subjects are "randomized" or assigned by chance the study drug or placebo, and they are "double blinded" meaning the subject nor will the study staff know which one subject has been assigned until the end of the trial. These studies further explore the safety and efficacy and are reviewed by the FDA (Federal Drug Administration) when considering drug approval. Most of the trials conducted at are Phase III trials. Phase IIB studies are also routinely conducted and explore an approved drug or treatment for use in other diseases. They are also performed to seek additional safety data or used for marketing purposes.
• Phase IV trials are known as "post-market" studies or studies of drugs that have received FDA approval. These trials are generally conducted to explore the long-term effects of a drug or treatment with a larger group of patients. Typically these studies are required by the FDA for these purposes. For more information on clinical trial phases or the FDA approval process, please visit the FDA website.

Clinical trials have specific guidelines that define who can and who cannot 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.

Before signing up for a study, find out as much as you can. Every study conducted at Lahey 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 and 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

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?
• What if I decide to participate but later change my mind and no longer want to participate?

If you have specific questions or concerns, contact the research coordinator or study contact for that study. In addition, talk it over with your primary care physician and family or friends, and weigh the potential risks and benefits.

To become a trial subject, you must first volunteer to participate in the trial. You must also meet certain eligibility criteria such as age, family history, disease duration and medication use. The sponsor of a clinical trial is usually a drug company.

To become a participant, follow these steps:

• Call or email the study coordinator or contact person. He or she will give you an overall description of the study and be able to ask you preliminary questions to see if you meet the eligibility criteria.
• Set up an appointment to meet with the doctor in charge of the study or with other members of the study team. If you appear to meet the preliminary criteria and are interested in the study, he/she may set up an appointment for you to meet with the principal investigator (PI) or physician in charge of the study.
• 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.
• If required, take additional tests to determine if you are eligible to participate. Once the results are evaluated, you will be told if you qualify for the study
• Once your eligibility is confirmed, you have entered the study and will be asked to return for follow-up study visits and/or testing, per the study outline. Set up an appointment schedule with the study coordinator, who will be your guide throughout your time on study.

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

Learn more about Research Participant’s Bill of Rights.

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.
• It’s your choice.