Clinical Trials

Clinical trials are research studies that involve people. Through clinical trials, doctors find new ways to improve treatments and the quality of life for people with disease. The team at Tahoe Forest Cancer Center participates in a wide variety of clinical trials in order to provide the highest level of care to the patients it serves. Clinical trials are the key to making progress against cancer.

Before a clinical trial is started, scientists must ensure that there is a chance that the new treatment will work better than the one available now. This research is carefully reviewed by independent scientists and community members on an Institutional Review Board (IRB). This is all done to ensure the new treatment is promising and safe to test in people.

Once clinical trials are approved to start for a new treatment, they are usually done in a certain order, called “phases.” The different phases are done to answer specific questions about the treatment and are designed to keep volunteers safe.

You may join any phase clinical trial. The clinical trial just needs to be appropriate for you, your health, and your cancer.

A phase I clinical trial is done to learn if a new treatment is safe for people.

In a phase I clinical trial, scientists collect information on:

• The dose or treatment
• When you take it, and how often
• Any side effects or problems
• How the treatment affects you, such as how it affects the cancer or side effects
• In a phase I clinical trial, you could be one of the first people to get the new drug or treatment
• Phase I clinical trials each last several months to a year. They usually have 10 to 30 volunteers. The treatment might help the cancer. Also, information from the clinical trial may help other people in the future.

There are few phase I clinical trials at Tahoe Forest Cancer Center. Your doctor may discuss referral to a specialty center for a phase I clinical trial.

A phase II clinical trial is done to learn more about how safe the treatment is and how well it works. This type of clinical trial will usually test whether a new treatment works for a specific type of cancer. The trial may focus on if the tumor responds to treatment or how well people do when they receive the treatment to determine how well the treatment works.

In a phase II trial, volunteers sometimes receive different treatments. For example, a phase II trial could have 2 groups.

Group 1 – People who receive the usual treatment for the condition. This is also called the standard treatment. It is the best treatment known.

Group 2 – People who receive the usual treatment plus the new treatment doctors are studying.

Or a phase II clinical trial could have 3 groups. Volunteers in each group get a different dose of the treatment doctors are studying. Often a computer will make the choice about which group the volunteer will be assigned to. This is called randomization, and it helps make sure it is accurate to compare the results of treatment in each group.

If the phase II clinical trial shows the treatment works and is as safe as the regular treatment, doctors can do a phase III trial.

A phase III clinical trial tests a treatment that worked well for volunteers in a phase II clinical trial and compares the new treatment with the standard treatment. There will generally be at least 2 groups in a phase III clinical trial and volunteers are assigned to a particular group by the process of randomization.

Phase III clinical trials can take many years. They may have several thousand volunteers. These must include men, women, and people of different ages and ethnic groups, if possible. This helps us understand how the treatment works in different people.

If a phase III clinical trial shows the treatment works well, doctors might begin using it with people outside the clinical trial. The results will be published in a report in order to inform other doctors and scientists about the results of the clinical trial. If the researchers or sponsor learn a new medicine is safe and effective, they can ask the government to approve it for people to use. In the United States, they ask the Food and Drug Administration (FDA) to review the research on a specific treatment, including each of the clinical trials. They approve the treatment if the results meet specific standards.

Doctors can prescribe a drug for their patients after the FDA approves it. However, there are times when the safety and efficacy of a treatment needs to be checked in large populations even after phase I – III clinical trials are complete. These clinical trials are called phase IV clinical trials.

Drug makers may do phase IV clinical trials because the FDA asks them to. Sometimes, a drug maker may do a phase IV clinical to get FDA approval to use the drug in a new way. The FDA may take away a drug’s approval if new research shows it is not as safe or effective as earlier testing showed. Doctors cannot prescribe it any longer if this happens.

A clinical trial is conducted under a specific plan, called a protocol, that acts like a recipe for conducting the clinical trial. Your doctor and the research team follow the guidelines in the protocol closely. The protocol will include:

• The reason for doing the study
• Who can join the study
• How many people are needed for the study
• The treatment plan including which drugs will be given, at what dose, how often, and for how long
• Description of other information that will be collected from volunteers participating in the trial

In order to participate in a clinical trial, volunteers learn the purpose, risks, and benefits of a clinical trial before deciding to join. This process is called informed consent and often includes a document that includes important information about a clinical trial to help potential volunteers decide whether to join. Informed consent is a critical part of ensuring patient safety in research.

There are multiple ways that volunteers are protected in clinical trials. Federal rules exist to help ensure the safety and ethics of clinical trials. An important component of the protection of volunteers is learning the purpose, risks, and benefits of a clinical trial before deciding to join, called informed consent. In addition, there are multiple reviews of clinical trials that are focused on ensuring protection of the volunteers that participate in a clinical trial. Some of these protections include:

• Careful review and approval of the clinical trial protocol by scientific experts
• Careful review and approval of the clinical trial by an institutional review board (IRB)
• Ongoing monitoring of the clinical trial by the IRB
• Ongoing monitoring of the clinical trial by the organization sponsoring the clinical trial.
• Ongoing monitoring by the research team.
• Some studies even have a separate independent Data and Safety Monitoring Board (DSMB) that will regularly review the outcome and safety of volunteers participating in the clinical trial.

As with any treatment option, a clinical trial has possible benefits, as well as drawbacks. You may want to discuss the following issues with your doctor and the people close to you.

• Clinical trials offer high-quality cancer care. If you are in a randomized study and do not receive the new treatment being tested, you will receive the best known standard treatment. This may be as good as, or better than, the new approach.
• If a new treatment is proven to work and you are receiving it, you may be among the first to benefit
• By looking at all your treatment choices, including clinical trials, you are taking an active role in a decision that affects your life
• You have the chance to help others and improve cancer treatment

• New treatments under study are not always better than, or even as good as, standard care
• If you receive standard care instead of the new treatment being tested, it may not be as effective as the new approach
• New treatments may have side effects that doctors do not expect or that are worse than those of standard treatment
• Even if a new treatment has benefits, it may not work for you. Even standard treatments, proven effective for many people, do not help everyone.

Learn more about participating in a clinical trial at https://www.cancer.net/research-and-advocacy/clinical-trials/welcome-pre…

There are two types of costs associated with a trial: Patient care costs and Research costs

Patient care costs: These are costs are related to treating the cancer, whether the patient is in a trial or receiving standard therapy. These costs might include doctor visits, hospital stays, clinical laboratory tests, x-rays, and any other medical costs that occur regardless of whether a patient is participating in a clinical trial or receiving standard treatment. These costs are usually covered by a third-party health plan, such as Medicare or private insurance.

Research costs: Research costs are costs that are associated with clinical trial participation, such as data collection and management, research physician and nurse time, analysis of results, and tests performed purely for research purposes. Such costs are usually covered by the sponsor of the clinical trial, such as a pharmaceutical company.

For more information about insurance coverage for clinical trials, see “Paying for Clinical Trials” on the National Cancer Institute’s website at http://www.cancer.gov/about-cancer/treatment/clinical-trials/paying.

There are a number of steps to finding a clinical trial that might be appropriate for you. The first step is to talk to your doctor about your medical condition and ask what clinical trials might be available for you. The doctors at the Tahoe Forest Cancer Center have partnered with leading cancer institutions to provide clinical trials to the community.

A list of clinical trials at Tahoe Forest Cancer Center can be found at
https://clinicaltrials.gov/ct2/results?cntry=US&state=US%3ACA&city=Truckee&recrs=a&age_v=&gndr=&type=&rslt=&Search=Apply

Learn more about finding clinical trials at
https://www.cancer.gov/about-cancer/treatment/clinical-trials/search/trial-guide