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Guide to Clinical Trials at the Transplant Institute

BIDMC investigators in the Transplant Research Center help "translate" their laboratory discoveries into clinical trials that eventually lead to improved treatments that benefit patients here and elsewhere. Clinical trials are research studies that evaluate new procedures or drugs, weighing their effectiveness against current, standard protocols.

Our acclaimed clinical research team offers patients novel treatment options through a number of clinical trials. Through these special research studies, patients can access new, potentially more effective treatment options before they become more widely available.

For More Information

ClinicalTrials.gov provides patients, family members, and members of the public easy and free access to information on clinical studies for a wide range of diseases and conditions.

The American Society of Transplantation (AST) offers a number of on-line patient education brochures including "The Facts About Clinical Trials."

We have also prepared:

  • A general discussion about clinical trials in our Transplant Institute, including the risks and benefits of being part of a clinical trial, the safeguards we have in place here for patient protection, and eligibility among other topics
  • "A Guide to Clinical Trials" brochure for additional information
  • A list of the clinical trails available to our patients prior to transplant, at the time of transplant, and after transplant

Please call the Transplant Institute at 617-632-9700 if you have questions about clinical trials, or ask your transplant team to explain your available options. Transplant Institute physicians are aware of the many clinical research projects underway at the medical center and will refer patients to any appropriate trials.

A Guide to Clinical Trials at the Transplant Institute

Clinical trials are also called research studies. Research studies test many types of treatment in patients who are waiting for or who have undergone a transplant. These studies include new medicines such as anti-rejection and anti-infection drugs, new approaches to surgery, new combinations of treatments, and psychological or behavioral health interventions. The Transplant Institute at Beth Israel Deaconess Medical Center is currently involved in a number of clinical trials that are available to patients prior to transplant, at the time of transplant, and after transplant.

The goal of clinical trials at The Transplant Institute is to learn and understand the best ways to:

  • Take care of transplant recipients
  • Prolong survival of the transplanted organ
  • Prolong life expectancy
  • Enhance quality of life
  • Improve medications currently used for transplant patients
  • Improve psychological functioning and behavioral health

Possible Benefits of Being Part of a Clinical Trial

  • If the treatment under study has a positive effect, you may be the first to benefit.
  • What doctors learn in studies may help people who need a transplant in the future.

Possible Risks of Being Part of a Clinical Trial

  • New treatments are not always better than standard treatments and, in some cases, may not be as good.
  • Treatments in research studies may have known or unknown side effects.

Safeguards That BIDMC has in Place for Patient Protection

  • Research studies undergo multiple levels of review before they are approved to begin treating patients.
  • The BIDMC research committees review all research studies.
  • The BIDMC Institutional Review Board (IRB) performs a final review. Members of the IRB are health professionals along with people from the community much like you. The IRB protects patient safety by reviewing the trial protocols and making sure that the informed consent document explains the risks, potential benefits and alternatives.
  • Throughout the clinical trial, you will see your doctor on a frequent and regular basis.
  • You are able to withdraw from the clinical trial at any time.
  • The trial is stopped immediately if the patients experience harm.

You Might be Eligible for a Clinical Trial

The Transplant Institute reviews every patient for his or her eligibility to participate in a clinical trial. Your doctor or another person on the research team will let you know if a clinical trial is right for you. Before you agree to participate in a clinical trial we will explain the following:

  • Why the clinical trial is being done
  • What will happen during the clinical trial
  • The plan for the clinical trial including the required visits and tests
  • What side effects you may have
  • How the clinical trial may affect your daily life

You will be able to ask any questions you might have about the clinical trial. The research team will give you a copy of the informed consent form that explains all the details of the clinical trial. The team will ask you to take a copy of the informed consent form to review and share with people who will be part of your decision. If you decide to take part in the clinical trial, we will ask you to sign the informed consent form in the presence of your physician. If you sign the informed consent form, you can still change your mind and withdraw from the clinical trial at any time without jeopardizing your transplant treatment.

It is important to look at all your treatment options with the help of your family and doctor to decide if a clinical trial is the best approach for you.

Questions to Ask Before Taking Part in a Clinical Trial

About the clinical trial

  • Why is this clinical trial being done?
  • How will it help me?
  • What will happen to my transplant with or without this treatment?
  • How do the risks and side effects of the standard treatment compare with the treatment being studied?

During the clinical trial

  • What kind of tests and treatments are part of the clinical trial?
  • How could the clinical trial change what I do every day?
  • Will I have to stay in the hospital during the clinical trial? If so, how often and for how long?
  • How long will the clinical trial last?
  • Who will have access to my medical record? How am I protected?
  • How will I be checked after the clinical trial?

Costs

  • Will my insurance cover being in the clinical trial?
  • Will I have extra costs because of the clinical trial?

To Learn More About Clinical Trials at the Transplant Institute

  • Call the Transplant Institute at 617-632-9700
  • Ask your doctor or nurse to explain your available options
  • Visit the NIH Clinical Studies web site. ClinicalTrials.gov provides patients, family members, and members of the public easy and free access to information on clinical studies for a wide range of diseases and conditions.