Clinical Trials FAQ

Clinical trials are medical research studies that involve volunteer participants. Clinical trials are created by medical doctors and researchers to compare existing medicines or treatments (like chemotherapy for cancer) and medical procedures (like surgery) and devices (like a heart valve) to learn if they are better than what is currently being given to patients. All medicines, treatments, procedures and devices that patients get today were first tested in a clinical trial.

Clinical trials are how medical doctors and researchers discover new treatments that benefit current and future patients. Through clinical trials, doctors can:

• Learn which drugs and treatments are safe and work best
• Decide which drugs and treatments are better than the ones currently available
• Find new ways to prevent or find a disease, such as cancer, early
• Help make the lives of patients with a disease better and more comfortable during and after their treatment

There are four phases of clinical trials.

• Phase I trials are studies that determine if a new treatment is safe.
•  Phase II trials are studies that determine if a treatment is effective, or if it helps treat the disease it is being studied in.
• Phase III trials are studies that determine if a new treatment is better than the current best known treatment for a cancer, or the “standard of care.”
• Phase IV trials are studies that look at the long-term safety or impact of drugs or treatments that have already been FDA-approved. These studies are very rare.

Everyone should consider joining a clinical trial. For drug studies, patients newly diagnosed with cancer; patients who have had cancer in the past but it has spread or returned. For prevention studies, healthy people can participate.

Being part of a clinical trial helps doctors learn if new drugs, devices, and procedures work on all kinds of people – young and old, and men and women of diverse ethnic backgrounds. The more doctors know about how a drug, device, or procedure works in patients, the better the treatment will be for everyone, now and in the future. Participating in a clinical trial can offer you the most advanced treatments, sometimes even years before they are widely available.

A good time to discuss a clinical trial with your doctor is when you are first diagnosed with cancer. Some clinical trials are for patients as their first and only treatment, others are for patients who did not respond to the first cancer treatment. Still others are for patients with cancers that have no treatment.

There are different ways patients can find out about new clinical trials or clinical trials that are currently looking for participants. First, every clinical trial is expected to be registered on the website: clinicaltrials.gov. Also, for clinical trials at the Herbert Irving Comprehensive Cancer Center, patients can ask their doctor and clinical team about trials or they can search for specific trials on the HICCC website, under Find a Clinical Trial.

Learn More About the Steps to Joining a Clinical Trial

By the time a clinical trial has been designed and open for patients, the treatment has already made it through comprehensive pre-clinical stages. This means that extensive studies have already been conducted on the treatment in the lab before it reaches the clinical trials stage to study in people. Additionally, all clinical trials must follow strict guidelines to protect patient safety that are monitored by the Federal Government. Each clinical trial follows a careful plan, called a study protocol, that outlines exactly what the researchers will do. An Institutional Review Board, or IRB, at each institution must approve every clinical trial before it enrolls participants, and regularly reviews the study and results to make sure that the risk (or potential harm) to the participants is as low as possible.

Although you sign consent before starting a clinical trial, you can decide to stop the treatment at any time. Your clinical trials team will continue to provide care for you whether or not you are in a study.

Your doctor will work closely with the clinical trials team during your treatment on a clinical trial. Your team will communicate with you about the risks of the study treatment, and they will monitor you closely during and after the clinical trial.

The impact on your daily life will vary depending on the type (or phase) of the clinical trial. Some trials may require receiving the new drug treatment orally, while some phase 1 or 2 trials could require a multi-day stay in a hospital for observation by the designated clinical trials team. The day-to-day impact on a person’s life will vary and should be discussed with the clinical trials team during pre-screening.

The length of a clinical trial, or the amount of treatments you will receive, depends on the specific clinical trial. Some trials may be for one treatment. Others may continue for many treatments.

Once the trial is completed, participants are monitored by the clinical trials team for a period of time, which varies by clinical trial. The monitoring usually includes regular visits with routine check-ups and sometimes additional tests. This information will be provided in the consent document, which our clinical trials team will review in detail with you and answer any questions you might have prior to joining the trial.