Why should I participate in a clinical trial?

People choose to participate for various reasons. A majority of patients who enroll in clinical trials say that they want to help others and that they want to help advance medical science. Patients are sometimes interested in receiving investigational medications before they are made available to the public, and sometimes have not found conventional treatments to be adequate.

Study related physical exams, medical testing, and investigational drugs are all provided free of charge. In most studies patients receive some compensation for their participation.

Patients must always keep in mind that most trials have one or more treatment groups, as well as a control group, and that neither they nor their doctor can specify to which group they will be assigned.

Your participation is completely voluntary.

How do I enroll in a clinical trial?

For more information about a particular trial, click the desired trial to the left side of this page. Each trial has specific criteria that must be met for participation. These criteria ensure that the investigational medication will be tested in the specific patient population designated by the pharmaceutical company sponsoring the trial. While these criteria are quite specific, on occasion a waiver will be granted if most, but not all, of the criteria have been met. The first step in enrolling in a trial is to discuss these criteria with the study coordinator to be sure that you are eligible. A preliminary assessment can usually be done over the phone. If you meet the major criteria, then you will be asked to come to our offices at 342 Montauk Avenue in New London where the specifics of the trial can be discussed in detail, and where you will be provided with information with which you can choose whether to participate. You will be asked to review and sign an Informed Consent Form that has been approved by the Institutional Review Board that has reviewed the trial.

Once the paperwork has been completed you will have study-related testing that often includes blood work, but that may require other testing such as EKG, bone density testing or other testing. These tests will be provided free of charge. Also, a study related physical exam will be performed. Once all of this testing has been done, if the test results are appropriate, then you will be enrolled in the trial and randomly selected to the treatment group or the control group. In some studies this can only be done after a certain period time has elapsed during which you may be asked to keep a daily diary, or to perform some other form of record keeping.

What can I expect during the trial, and how long will it last?

Trials differ both in length of time and in what they require of their participants. Usually there is a schedule of visits that must be maintained during the trial. You may be asked to keep a journal at home, or to fill out questionnaires at the time of your visits. In some trials there are examinations or tests that must be performed at set times during the trial. All of these requirements will be explained to you by the study coordinator, and you should not hesitate to ask any questions you may have about them. You will meet with the study coordinator at each of your visits, and on certain visits with the physician as well.

We are happy to discuss the trial with your other health care providers, and we may ask your permission to obtain certain medical records from them. Throughout the trial, we would like you to inform us of any changes in your health, or of any changes in medications that you take, even if these changes seem unrelated to the clinical trial.

What happens when the trial is completed?

It generally takes some time to analyze the data from a clinical trial, but when this is done, the pharmaceutical company will decide whether to proceed with additional testing, or with an application to the FDA for approval to market the medication. Only after the data has been analyzed will the company inform us whether you were in the treatment group or the control group. On occasion the company will provide for an "open label" extension of the trial where all patients may receive the treatment medication for a predefined period of time.