Clinical Trials 101
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What Is a Clinical Trial?
A clinical trial is a highly-controlled biomedical research study, which aims to test the safety and effectiveness of new treatments, diagnostics, and methods of screening and prevention. Once an experimental treatment reaches the clinical trial stage, it has already gone through a lengthy, rigorous scientific process. Clinical trials are all strictly regulated for eligibility and safety.
Every treatment available today is the result of a clinical trial. Yet only three percent of U.S. adults with cancer (all cancer types) participate in clinical trials, but it is estimated that 20 percent are eligible.
A patient is eligible to participate in a clinical trial at any point in their experience with ovarian cancer. Many people think of clinical trials as a “last resort” option – one to explore only after other treatments have failed – but this isn’t the case at all. Many equally important trials are available for patients earlier in their fight against ovarian cancer.
Clinical trial participants will never receive just a placebo. Everyone who participates will receive either standard of care treatment, or the new treatment that is being tested. In this way, clinical trials offer two invaluable benefits: for the individual, they have potential to succeed where other treatments have failed – and at the same time, they accelerate scientific progress for everyone.
If you are interested in a clinical trial, you should not hesitate to ask your doctor about whether there are trials that might be right for you. If your physician does not know how to find trials, refer them to the Find a Clinical Trial section of this site. Our Questions to Ask Your Doctor will help prepare you to discuss clinical trials with your medical team.
Who conducts clinical trials?
Every clinical trial has a “sponsor” that oversees the conduct of the trial. The National Cancer Institute and other parts of the National Institutes of Health and the Department of Defense sponsor and conduct ovarian cancer clinical trials.
In addition, organizations or individuals, such as medical institutions, pharmaceutical and biotech companies, and even individual physicians sponsor clinical trials.
Where are clinical trials conducted?
Clinical trials take place in all kinds of locations where people receive medical care across the United States.
- Doctors’ offices
- Major hospitals and cancer centers
- Community hospitals and clinics
Phases of Clinical Trials
Clinical trials occur in sequential phases, each of which serve a different function. Here is how the National Cancer Institute describes the trial phases:
In Phase I trials researchers test an experimental drug or treatment in a small group of people (20-80) for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
In Phase II trials, the experimental study drug or treatment is given to a larger group of people (100-300) to see if it is effective and to further evaluate its safety.
In Phase III trials, the experimental study drug or treatment is given to large groups of people (1,000-3,000) to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the experimental drug or treatment to be used safely.
In Phase IV trials, post marketing studies delineate additional information including the drug’s risks, benefits, and optimal use.
Types of Ovarian Cancer Clinical Trials
There are many different types of clinical trials for ovarian cancer patients. Trials can focus on prevention, screening, diagnostic, treatment, quality of life and supportive care, or genetics.
What is a prevention trial?
Prevention trials test ways to reduce the risk of ovarian cancer. They typically enroll healthy women at high risk for developing ovarian cancer or survivors who want to prevent its return or reduce the chance of developing a new type of cancer.
What is a screening trial?
Screening trials look for ways to detect ovarian cancer at an early stage in healthy women.
What is a diagnostic trial?
Diagnostic trials seek to develop better ways to diagnose and care for patients with ovarian cancer. They usually enroll patients who have already had ovarian cancer or who have signs and symptoms of it. Many of the current diagnostic trials in ovarian cancer focus on proteomics, which involves evaluating the levels of different proteins in the blood.
What is a treatment trial?
Treatment trials determine what new treatments or combinations of existing treatments can help women with ovarian cancer. They evaluate the effectiveness of new treatments or new ways to use existing treatments. (A “treatment” may be a drug, therapy vaccine, surgery or any combination of these.) Various treatment trials exist, most of which explore the effectiveness of different combinations of surgery and drug therapies in fighting ovarian cancer.
What is a quality of life or supportive care trial?
These trials aim to improve the quality of life for ovarian cancer patients, survivors, and their families. These may include issues like side effects from chemotherapy like neuropathy or nausea, or need for pain medication.
What is a genetics trial?
Usually part of another clinical trial, genetics trials attempt to determine how a woman’s genetic makeup can influence the detection, diagnosis, prognosis and treatment of ovarian cancer. (Family-based genetic research studies exist that differ from cancer clinical trials; in these studies, multiple high-risk family members may give blood and tissue and agree to be evaluated on an annual basis.)
Costs of Clinical Trials
Many people wonder, what are the costs associated with enrolling in a clinical trial? The clinical trial sponsor pays for the costs associated with the treatment under study, such as drugs being compared, and will pay the extra costs associated with additional testing or doctor visits required by the trial’s protocol. Routine patient costs, such as doctor visits, hospital stays, laboratory tests, are the costs of medical care you would have received if you were not in the trial. Some health insurance plans may not cover routine patient care costs in a clinical trial. You should work with the clinical trial research coordinator to help you find out if routine costs are covered by your insurance plan. To try to help get an insurance company to pay for a trial, the National Cancer Institute, suggests that you ask the research coordinator to provide you with medical literature that show potential benefits of the treatment tested, a letter of clinical necessity, documentation from the researchers explaining the clinical trial, and support letters from an advocacy group to submit to an insurer.
Does insurance cover clinical trials?
Health insurers use several criteria to determine whether to cover the costs of a clinical trial. According to the National Cancer Institute:
- If you live in a state that requires coverage for clinical trials. For more information go to States that Require Health Plans to Cover Patient Care Costs in Clinical Trials
- If the policy allows coverage of routine patient care in a clinical trial
That the trial is medically necessary, which is decided usually on a case-by-case basis
- If the trial is a phase III, the insurer might cover it because the treatment has already had success in many people
- If the routine costs of care in the trial are comparable to the costs for standard treatment
- The trial is sponsored by the National Institutes of Health or one of the groups it funds.
There are also resources available from not-for-profit organizations to help with the costs of clinical trials. You may be able to find assistance by searching through this directory on the NCI website.
Clinical Trials Process
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. OCRA, for example, co-sponsors clinical trials.
The research team
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.
After a clinical trial is completed
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.