Do I have to be a Lahey patient to participate in a clinical trial?
No. Anyone fitting the eligibility criteria can be accepted in a Lahey Clinic clinical research trial.
When will I know whether I am accepted in a study?
It depends on the screening process. Certain drug studies may require additional tests and evaluation of your medical history before you are accepted. This may take a little time.
How will I know when I have been accepted?
Sometimes when you meet with the principal investigator, you are accepted immediately into the study. Other times, a clinical research associate (CRA) will call to let you know if you have been accepted and answer any further questions.
What is the time period from notification to the start date?
This varies. Some trials start immediately, while others may take a few months.
Who contacts me?
The CRA will call and let you know when your first appointment is.
Will I have someone at Lahey Clinic whom I can contact if I have questions or problems?
Yes. The CRA will arrange an appointment schedule for you and help to answer any questions you may have about the study. You will also receive a list of contact persons once you become a volunteer in the study.
What if I decide not to participate in the study?
You need to contact the CRA before the study begins so another patient volunteer can take your place.
Will other Lahey Clinic locations besides Burlington be doing the same study?
Sometimes Lahey Clinic Medical Center, North Shore, in Peabody or Lahey Arlington are involved in the same study. But most research is conducted at one location. Are other hospitals participating in the same studies? Sometimes there are "multisite" trials with other hospitals. However, we are not always notified of other facilities participating in the same study.
What are Phases I, II and III of a study?
In Phase I, the first test outside of the laboratory, a small number of patients receive the new treatment and researchers study its safety. In Phase II, researchers determine the effects of the treatment on disease. In Phase III, the new treatment is compared to standard treatment to see which is more effective.
Am I ever paid to be in a study?
Yes. Payment depends, however, on the particular study. Sometimes travel compensation is provided.
Does my insurance company pay for me to participate in a study?
If you are participating in "research only," then insurance does not pay to have you participate. If you need "standard of care" along with the study, then your insurance pays that part. HMO patients may need a referral to participate in a study and should contact their provider to verify coverage.
Are all risks in taking experimental medications or treatments explained to me before the study begins?
Yes. The doctor or principal investigator (PI) will inform you of any risks before you start the trial.
Do I have to have all my required tests done at Lahey Clinic?
We do like 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.
What happens if I get sick or have a reaction to a study medication?
Immediately contact the PI or doctor who heads your study. If you cannot reach the doctor and are having a severe reaction, go to the nearest emergency room.
What if I have to miss or cancel a scheduled appointment?
Contact your CRA if you know that you have to miss an appointment. She or he will try to work around your schedule. Sometimes appointments are "time-sensitive" and need to be booked again quickly.
What if I have to quit a study before it ends?
This sometimes happens, and you need to notify the CRA as soon as possible.
Will I be told if placebos are used in my study?
Before the trial begins, you will be informed if placebos or inactive substances will be given. However, you won't be told who will or will not receive them.
Will my own doctor be regularly informed about my status in the study?
Your doctor will be informed about your involvement in the study but not on a regular basis.
Do I see my regular doctor while I am in the study?
Yes. It is important that you continue ongoing care with your primary physician.
Does Lahey have "compassionate use" in its studies?
Yes, but it is subject to certain situations and drug availability.
Can I continue taking the medication after the study ends?
Drugs already approved by the Food and Drug Administration (FDA) may be continued after the study is completed. Non-FDA approved medications must be stopped.