Before you can join a clinical trial, your eligibility to participate has to be determined. Inclusion and exclusion criteria are used so that patient safety is maintained, particular research questions can be answered, and credible results are obtained. Your age, health, previous medication history, and type and stage of ovarian cancer, are factors used to determine your eligibility.
Before participating in a clinical trial, research coordinators will explain the purpose, procedures, risks and benefits of a trial. Translators are available for people who do not speak English. Once you fully understand what the trial entails, you will be asked to sign a document that includes in writing details about the study. The informed consent document is not a contract and you can leave a trial any time you wish. You can also always ask the staff members of a trial any question you have while the clinical trial is ongoing.
Federal rules and local laws ensure that clinical trials are performed ethically and respect the safety and rights of the patient. A clinical trial is evaluated by scientific review panels and Institutional Review Boards (IRB) before it can begin. A Scientific Review Panel, comprised of experts, determines whether a clinical trial protocol has sufficient scientific merit before patients participate. Members of an IRB, including physicians, statisticians, researchers, community activists and others, also review a trial’s protocol before patients are enrolled to make sure the trial’s benefits outweigh its risks. IRBs and Data Safety and Monitoring Boards for Phase III trials monitor ongoing trial progress. DSMBs, which include physicians, statisticians and other experts, work to minimize risks, ensure data is unbiased and accurate, and stop a trial if safety concerns arise.
Trials take place in cities and towns throughout the United States, and other countries. Doctors’ offices, cancer centers, medical centers, community hospitals, clinics and veterans’ and military hospitals are all possible venues for clinical trials. Some trials may only take place in one facility, such as a large medical center, while other trials occur at multiple locations.
There are a variety of sponsors of clinical trials, including government agencies, such as the National Cancer Institute, organizations, physicians, academic medical centers, foundations, and biotechnology and pharmaceutical companies. Various groups work together to form networks, such as the Gynecologic Oncology Group, which designs and manages the majority of the ovarian cancer clinical trials in the United States. OCRFA, for example, co-sponsors clinical trials.
A research team, including doctors, nurses, research assistants, and data analysts, manages the trial. They work with other health care professionals, including laboratory technicians, pharmacists, dieticians and social workers to provide medical and supportive care for participants. The research team checks your health at the beginning of the trial, gives instructions regarding the protocol you are participating in, monitors your health carefully during the trial and stays in touch after the trial is completed. They will also respond to any side effects you may be experiencing. Some clinical trials require more tests and doctor visits than you would have gotten normally. Trial success depends on adhering to the protocol strictly and maintaining frequent contact with the research staff. You will also stay in contact with your regular health care provider, who communicates with the research team.
There are routine care costs and research costs for people participating in clinical trials. Routine care costs are the costs of treating a person’s cancer whether or not they are in a trial. These costs are usually covered by health insurance, but reimbursement requirements vary by state and type of health plan. Research costs are costs associated with the clinical trial and may include the costs of extra doctor visits, additional tests, and procedures required for the trial but are not part of routine care. Research costs are usually covered by the organization that sponsors the trial. Clinical trial participants need to determine whether they might incur additional costs by being in a clinical trial because of where they live and the type of insurance they have.
After a clinical trial is over, the data collected is analyzed to understand the results and whether it is necessary to plan additional research. The results are usually published in peer-reviewed scientific journals so expert medical “peers” can assess the integrity of the research findings. Sometimes important results are announced at scientific meetings, which get covered in the media, before the findings are published. After an intervention has proven safe and effective in a clinical trial, it may become a new standard of care.