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A Study of Niraparib Maintenance Treatment in Patients With Advanced Ovarian Cancer Following Response on Front-Line Platinum-Based Chemotherapy

Clinical Trials FAQ

It isn’t possible for every physician to open every available clinical trial at his/her office. It takes a considerable amount of extra work and often, additional staff to ensure that clinical trials are run efficiently and according to the research protocol (the detailed description of exactly how a clinical trial must be run). Physicians are more likely to open a clinical trial at their hospital/clinic if they feel that they have a sufficient number of patients who might qualify for it. Many hospitals/clinics list the clinical trials that they offer on their webpage.

No. Every clinical trial has a set of criteria that all participants must meet. Usually, these include requirements having to do with health history. There are clinical trials for patients at various stages of their disease – not only for those who have no other options available to them.

It is important to TESARO that we give you as much information as we can to enable you to make an informed decision. It is also important to know that the U.S. Food and Drug Administration has strict requirements for what must be included in all informed consent forms. Required information: 1) a description of the clinical trial, 2) a description of possible risks or discomforts, 3) a description of benefits that may be expected, 4) alternative procedures that might benefit the participant, 5) how confidentiality will be protected, 6) an explanation as to whether any medical treatment will be available if injury occurs, 7) whom to contact with any questions or in the event of a research-related injury, 8) a statement that participation is voluntary, that refusal to participate will not involve any penalty and that participants can withdraw consent at any time.

There are certain criteria that all participants in a clinical trial must meet. These are often referred to as “inclusion criteria.” In some trials, particular screening assessments are necessary in order to determine whether or not a potential participant meets all of the inclusion criteria for the clinical trial. It may take some time for the results of these assessments to become available, therefore delaying the time when a participant can begin a trial.

The cost of drugs/procedures that are being done strictly for the research study are usually covered by the study. That is not always the case for drugs/procedures that would be given/done if the patient was not taking part in a clinical trial.