If you have a severe or chronic illness, participating in a clinical trial to evaluate a new treatment may offer you a chance to improve and/or extend your life. You may have already heard or read about a clinical trial at Lahey Hospital & Medical Center and want to learn more, or you may be just starting to explore this option
The Department of Neurology conducts many clinical trials for various neurological conditions, including:
For a complete listing of ongoing clinical trials and whom to contact for additional information, visit the Lahey Web site at www.lahey.org/ClinicalTrials/
Clinical trials are often referred to as "drug trials" or "device trials". They are research studies where a drug or device company or investigator is trying out a new medication or treatment for a specific disease or condition. The drug used in a clinical trial is referred to as an "investigational" drug, meaning it has not yet been approved for patient use. Clinical trials are conducted to determine the investigational drug's safety and effectiveness, the most effective medication dose, how a drug might affect a person's body and may look at DNA in order to explore a genetic cause of a certain condition or disease.
The sponsor will select a Lahey physician to be the site principal investigator (PI) of their trial. The site PI will be the person "in charge" of running the trial at Lahey Hospital & Medical Center and is typically selected based on his/her experience with the disease being studied. Sub-investigators and research staff will also assist the PI with the conduct of the trial.
To become a trial subject, you must first volunteer to participate in the trial and you have to 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. For more information on becoming a trial participant, click here.
Before a clinical trial can be conducted at Lahey Hospital & Medical Center, it is reviewed by the Lahey Institutional Review Board (IRB). The IRB is composed of medical professionals, physicians, non Lahey employees and laymen. The IRB reviews the trial protocol which describe the sponsor and principal investigators credentials, purpose and duration of the trial, the background research that has been performed to date, the schedule and types of tests and procedures a trial is requiring, the eligibility criteria (who is eligible to participate), the study medication and dose and any materials which may be provided to the subjects.
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 invitro (test tube or culture) and invivo (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, or 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 the study staff will know which the 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 in the Department of Neurology at Lahey Clinic are Phase III trials. Phase IIIB studies are also routinely conducted and explore an approved drug or treatment for use in other diseases, are performed to seek additional safety data or are 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.
Before signing up for a study, find out as much as possible about the study. Contact the appropriate person by phone or e-mail and ask for details about the clinical trial. You may receive additional materials that include:
Carefully read over the materials to determine if you are eligible to participate. You may want to discuss it with your family, friends and/or primary physician.
For a glossary of clinical trial terms, visit: http://clinicaltrials.gov/ct2/info/glossary
To become a patient volunteer for a clinical trial, follow these steps: 1. Call or e-mail the appropriate contact. 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.2. 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.3. Meet with the PI, who will further explain the study to you and answer any questions you may have. The study coordinator will also meet with you at this time.4. Sign an "Informed Consent" form, which means the study details have been explained to you and that you agree to participate in the clinical trial. This also indicates that you understand who is sponsoring the study and the potential risks and benefits of the treatment.5. If required, take additional tests. Once the results are evaluated, you will be told if you qualify for the study.6. 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.
If you have specific questions or concerns, call the contact person for the study. In addition, talk it over with your primary care physician and family or friends, and weigh the potential risks and benefits. Click here for frequently asked questions.
Neurological research helps to further our understanding of neurological disorders, such as Parkinson’s, ALS, Multiple Sclerosis, stroke, and epilepsy, amongst other diseases and disorders. To support the Neurology Department contact the Philanthropy Office at (781) 744-3333. To learn how your support may help, click here.
To learn more about research trials in Neurology at Lahey Hospital & Medical Center please contact our clinical research specialist:
Stephanie Scala, MA, CCRPLahey Hospital & Medical CenterClinical Research31 Mall Rd.Burlington, MA 01805P: 781-744-2950F: 781-744-3772E: Stephanie.A.Scala@Lahey.org
RESEARCH IN NEUROLOGY
The American Heart Association/American Stroke Association's Get With The Guidelines program has again awarded Lahey Clinic’s stroke service the Stroke Gold Performance Achievement Award.