If you have ovarian cancer, it can be helpful to know that clinical trials may provide another treatment option.
Clinical trials are research studies done with people to evaluate the efficacy and safety of new treatments. They also help researchers compare new treatments to existing standard treatments. The people who participate in clinical trials are volunteers.1
There are many different types of clinical trials. For example, some test new ways to find disease. Others may explore ways to improve quality of life or treatments.
Clinical trial phases
Clinical trials for new drugs or treatments usually go through 4 different phases. Each phase has a specific goal.
Phase 1
Phase 1 usually includes a small group of volunteers (usually 20 to 80 people). During this phase, researchers judge the safety and side effects of a drug or treatment. They will also work to find the correct drug dosage.1
Phase 2
Phase 2 studies include a larger group of people, usually fewer than 300 volunteers. This phase focuses on the effectiveness of the drug or treatment. The goal is to gather data on whether the drug or treatment works in those who have a certain disease. The volunteers getting the drug or treatment may be compared to similar people receiving a different treatment. Researchers will also monitor people for side effects.1
Phase 3
Phase 3 studies include a much larger group of people, usually several hundred up to 3,000 volunteers. The goal of this phase is to gather more information about the drug or treatment’s effectiveness and safety. Researchers may study different groups of people and dosages during this phase. They may also use the drug or treatment along with other drugs.1
If the drug or treatment is found to be safe and effective after the first 3 phases, the U.S. Food and Drug Administration (FDA) will typically approve it for clinical use. However, researchers will still monitor the drug or treatment for a period of time.1
Phase 4
This phase takes place after the FDA has approved the drug or treatment. Researchers continue to monitor its safety, effectiveness, and best use in large, diverse groups of people.1
It may take many years for a drug or treatment to go through all the required steps to become an approved treatment. Some potential drugs or treatments fail to show that they are effective or safe. This means they will not move to the next phase.1
Benefits of participating in clinical trials
People take part in clinical trials for a variety of reasons. Some of the benefits of doing so may include:2
- Access to a new treatment before it is widely available
- Helping others get a new or better treatment in the future
- Receiving closer monitoring and more check-ups while in the trial
- Having more access to support services during the trial
Challenges of participating in clinical trials
While clinical trials have many benefits, they are not without their challenges. These challenges may include:2
- The new treatment may cause serious side effects.
- The treatment may not work or may not be better than your standard treatment.
- You might not be getting the experimental treatment. Some people enrolled in clinical trials are part of the control group. This means you get the standard treatment without also receiving the experimental treatment.
- The trial might impact your life due to things like time obligations, hospital stays, and side effects.
Things to consider
Joining a clinical trial is not for everyone. Clinical trials often have specific requirements for people who wish to join them. Not all people with the same condition will be eligible to join the same trial. Some criteria are based on the disease or previous treatment. Other criteria may relate to things like age, gender, and other medical conditions.1
If you are interested in joining a clinical trial, talk to your doctor. They may know of a trial for ovarian cancer that you may be able to join. Your doctor can tell you more about the possible risks and benefits, and what your participation may mean for your treatment.