About Clinical Trials
Clinical trials are voluntary research studies to determine whether an investigational drug is safe and effective to treat a disease. Cancer clinical trials are designed to test potential new treatments for cancer, with the goal of eventually improving available treatment options. Clovis Oncology is conducting clinical trials with rucaparib to test it in women with ovarian cancer. By participating in a clinical trial, you may help improve our understanding and treatment of cancer. People who take part in clinical trials are vital to the process of improving medical care.
Who can participate in a clinical trial?
All clinical trials have criteria to determine who is, or is not, eligible to participate in the trial. These eligibility criteria ensure that investigational drugs are tested in a group of patients that are similar. Examples of eligibility criteria include age, sex, type and stage of disease, platinum sensitivity, and whether a person has received certain prior treatments. Eligibility criteria also help to exclude patients for whom the known risks may outweigh the potential benefit of an investigational medicine.
What can you expect during a clinical trial?
Your doctor will give you information to read about the clinical trial and answer any questions you have. Before you participate in a clinical trial: you will need to read a description of the trial and what your participation will involve, and you will need to provide your signature indicating your understanding of the trial and your agreement to participate (this is called your 'informed consent').
During a clinical trial, several healthcare professionals may be part of your study team – including doctors and nurses. Throughout the clinical trial, you will be followed by your study team. This team of medical experts will monitor your disease and wellbeing, and you will receive medical tests that are part of the clinical trial in addition to the medical tests that are part of standards of care. You may be asked to fill out forms, or provide additional information about how you are feeling. As part of some studies, samples of tumor tissue or blood may be required. You may choose at any time to stop your participation in a clinical trial.
What are the possible benefits and risks of participating in a clinical trial?
In clinical trials, the investigational agent may be studied in a single-arm or multi-arm trial. In single-arm trials, all patients will receive the investigational agent. In multi-arm trials, the investigational agent may be compared to placebo (an inactive substance or standard of care) and patients will receive the investigational agent or placebo.
Clinical trials do have risks, potential upsides and potential downsides. The investigational treatments being studied can be better or worse than current standard care. Even if an investigational treatment or medicine benefits some participants, it may not work for you. An investigational treatment may have side effects or risks that doctors don't know about or expect. Health insurance providers do not always cover all participants' care costs for clinical trials. If you're thinking about taking part in a clinical trial, ask ahead of time about costs and coverage.
You should learn about the risks and benefits of any clinical trial before you agree to take part in the trial. Talk with your doctor about specific trials you are interested in.