Clinical Trials
Cancer clinical trials are cancer research studies that involve people. The main purpose of a clinical trial is to find a better way to prevent, diagnose or treat a disease. Clinical trials are part of a long, careful research process. Patients who participate in a clinical trial receive drugs or procedures that already have been researched in successful laboratory and/or animal studies. Most clinical trials study new drugs or procedures, but some study drugs or procedures that have already received approval by the U.S. Food and Drug Administration.
Clinical trials offer a patient additional treatment options that may be better than standard treatments – the treatments that are accepted and widely used by medical experts. To be fair and ethical to patients, trials are designed so that an experimental treatment offered is anticipated to be better than standard treatment and at least as beneficial, with low anticipation that it would be worse. All patients who participate in clinical trials are volunteers. If you choose to enroll in a clinical trial, you can choose to stop participation at any time.
Cancer Care Center of Frederick has direct screening and access to enrollment for hundreds of clinical trials at the National Cancer Institute (NCI), many of which are not available anywhere else in the world. The NCI, part of the National Institutes of Health in Bethesda, MD, is the nation’s premiere cancer research center, where the newest scientific advances in cancer research are leading to breakthrough therapies. If you enroll in a clinical trial at NCI, we can continue to coordinate your care while you are receiving treatment at NCI.
Cancer Care Center of Frederick has also become a member of ECOG, the Eastern Cooperative Oncology Group, and will also be offering additional clinical trials for our patients through our office.
Not everyone is eligible for or interested in a clinical trial, but if you are curious about enrolling in a clinical trial, please talk with your oncologist.
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Clinical trials Q & AWhy are clinical trials important?
Clinical trials are important to develop new treatments for cancer. Many of today’s standard cancer treatments – are based on the results of previous clinical trials.
Who are the members of the clinical trials team?
Principal Investigator: The principal investigator, usually a doctor, is responsible for the design, development and conduct of the clinical trial. He or she evaluates data and helps participating doctors manage the trial. You will continue to see your primary doctor if he or she is not the principal investigator.
Research Nurse: The research nurse directs and coordinates patient care during a clinical trial, and is a good contact for patients who have questions. He or she will:
- Teach you about participation in the clinical trial
- Make sure the protocol’s instructions are followed
- Teach you about side effects
- Help manage clinical trial data
Clinic Nurse: The clinic nurse coordinates general patient care regardless of whether you participate in a clinical trial. He or she will meet with you during your doctor visits. Because the clinic nurse is a part of your health care team, you also may ask him or her questions.
What are the types of clinical trials?
As you research and learn about clinical trials, you may come across different types of trials:
- Therapeutic trials test new drugs, surgery techniques, radiation therapy procedures or other treatment methods on people with specific types and stages of cancer.
- Prevention trials study how healthy people may prevent cancer. People at high risk of getting cancer may benefit from participation in a prevention trial.
- Early-detection/screening trials discover ways to find early-stage cancer.
- Diagnostic trials find new and better ways to determine if someone has cancer – and, if so, where the cancer is located in the body; how much cancer is there; and whether or not it has spread to other parts of the body.
- Quality of life/supportive care trials seek to improve the comfort and quality of life of patients and their families or caregivers.
After promising treatments are explored in animal and/or laboratory studies, researchers perform clinical trials. Once the drug, device or procedure enters the clinical trials process, it must go through several phases:
- Phase I trials determine the safety of a new treatment
- Phase II trials determine whether a certain kind of cancer responds to a new treatment Phase III trials study whether a new treatment is better than standard treatment
- Phase IV trials find more information about a new treatment that has been already approved for use in patients
Phase I Trials – Determine if a new treatment is safe and effective in humans. Doctors also find the best way to give the treatment.
The goal of a Phase I trial is to:
Phase I trials usually include 15 to 30 patients who are divided into small groups. These groups are called cohorts. The first cohort receives a low dose of the new drug. Doctors may collect blood or urine samples to measure drug levels in the patients.
If the first cohort does not have any severe side effects, then a new cohort receives a higher dose of the same drug. The dose increases with each new cohort until the doctors find the safest effective dose. With each increasing dose, doctors test each patient to see if he or she is responding to the treatment.
If the doctors find that the treatment is safe, then it will move forward to be studied in a Phase II trial.
- Find out if a new treatment is safe
- Find the best way to give the new treatment, such as by mouth or by vein
- See if the treatment prevents the cancer from growing
Phase II Trials – Determine whether the new treatment works
The main goal of a Phase II trial is to examine how well the new treatment works to fight a certain kind of cancer. Less than 100 patients usually participate in a Phase II trial. Patients who volunteer for a Phase II trial may have been treated with chemotherapy, biotherapy, surgery or radiation and still need further treatment.In addition to evaluating how well the treatment works against the cancer, doctors continue to monitor side effects. Since more patients participate in Phase II studies, some of them may experience side effects that patients in the Phase I clinical trial did not have.
If the new treatment seems to be effective against cancer in a certain percentage of patients, researchers may consider it successful enough to continue study in a Phase III clinical trial.
Phase III Trials – Study whether the new treatment is better than standard treatment
The goal of a Phase III trial is to compare the new treatment with the standard treatment. Researchers track whether a new treatment is better than, the same as, or less effective than the standard treatment.
Phase III trials may include hundreds to thousands of patients around the country or world. In general, each patient enrolled in a Phase III clinical trial has an equal chance of participating in one of two or more arms (groups) of the study. In a clinical trial with two arms:
- The control group receives the standard treatment
- The investigational or experimental group receives the new treatment being tested
Randomization is the process of assigning participants to groups. Randomization helps avoid bias in the clinical trial. Bias occurs when human choices or other factors not related to the treatment being tested change a study’s results.
Neither the patient nor the doctor can choose whether the patient is in the control group or the experimental group. Regardless of which group a patient is assigned to, either he or she will receive the best standard treatment available or the new treatment that researchers believe is as good as, or better than, the standard treatment.
Single Blind Versus Double Blind Trials
- Single blind studies: patients do not know whether they are in the experimental or control group
- Double blind studies: neither the patients nor the researchers know which patients are in each group (although this information is recorded and on file if needed)
FDA Approval
The role of the U.S. Food and Drug Administration (FDA) is to make sure medical treatments are safe and effective for people to use. Researchers submit their clinical trial results to the FDA, and based on the information, the FDA may approve the drug or treatment. Then it becomes available to all patients and sometimes becomes the new standard treatment.
Phase IV Trials – Find more information about the new treatment
Phase IV clinical trials are not as common as Phase I, Phase II and Phase III trials. In Phase IV trials, researchers study drugs and/or treatments that have already received FDA approval. The goal of Phase IV trials is to study how safe and effective a drug or procedure is over time.
How does Cancer Care Center of Frederick protect patients?
When conducting clinical trials, our most important responsibility is to protect patients through well-designed protocols, a dedicated Institutional Review Board (IRB) and a careful informed consent process.
Clinical Trial Protocol
A protocol is a detailed plan that explains what will be done in a clinical trial and why. It outlines how many patients will participate, what medical tests they will receive and how often, and the treatment and monitoring plan. Researchers must follow the protocol approved by Frederick Memorial Hospital’s Institutional Review Board (IRB).
If you have questions or concerns about safety while participating in a clinical trial, please contact a member of your clinical trial team. If you still have questions about the study or your rights as a participant, contact the Chairman of the Institutional Review Board (IRB) at (240) 566-3300.
The Institutional Review Board
Cancer Care Center of Frederick works with the Frederick Memorial Hospital (FMH) Institutional Review Board (IRB). An IRB is a committee of people, such as doctors, nurses, scientists, dentists, chaplains, social workers, attorneys and patients who are responsible for protecting clinical trial participants and making sure that the trials follow federal laws.
Before a clinical trial can begin, the IRB reviews and approves the protocol to make sure that it is based on reliable scientific evidence. The IRB attempts to ensure that the protocol will not cause excessive harm to any patient.
After a clinical trial begins, the IRB monitors the trial at least once a year and stops it if any safety concerns arise. For example, if a patient developed dangerous side effects, then the trial would be stopped. It also may stop a clinical trial early if it becomes clear that the new treatment is much more effective than standard treatment, so that all participants may receive the better treatment.
The FDA regulates Frederick Memorial Hospital’s IRB by auditing IRB minutes, staff and facilities every 5 years. FDA officials also can visit Cancer Care Center of Frederick or FMH at any time and review anything they choose related to clinical trials.
The Informed Consent Process
If your doctors offers you the option to participate in a clinical trial, you will first take part in a process called informed consent. In this process you will learn details about a specific clinical trial so that you may decide whether you want to participate. The informed consent process is designed to make sure patients understand the clinical trial’s plan before agreeing to participate.
The researcher or nurse from the clinical trial team will review the informed consent form in detail with you. This form explains a specific clinical trial’s purpose, procedures, risks and benefits.
You will be encouraged to ask questions about terms or ideas that are confusing. A family member or friend may be helpful by listening to the explanation, asking questions and recording answers. Some doctors encourage patients to bring tape recorders so they can review the information afterwards.
You can take the informed consent form with you to think about whether you would like to participate in the clinical trial.
Information on the Informed Consent Form
Informed consent forms are different, but they should include:
- The reason for the clinical trial (what the researchers hope to learn)
- Who is eligible to take part in the clinical trial
- What is known about the type of treatment being studied
- The possible risks and benefits (based on what is known so far)
- Other treatments that may be options
- The clinical trial’s design (randomized, single blind, double blind, etc.)
- Types of tests, the number of tests and doctor’s visits required
- Who is responsible for the costs of the clinical trial (tests, doctor’s visits, etc.)
- Who is responsible for the costs if a patient needs additional care as a result of the clinical trial
- A statement about conflicts of interest
- A statement about protecting the patient’s privacy
- A statement about the clinical trial being voluntary and the patient’s rights to leave the clinical trial at any time
- Contact information for further questions
Some informed consent forms are translated into Spanish. If you decide to participate in a clinical trial that has an informed consent form written in Spanish, you, your doctor, and a witness who is fluent in Spanish will sign and date the form, and you will be given a copy.
If the informed consent form is written in English, then you will be given a Verbal Translation Preparative Sheet written in Spanish.
The Verbal Translation Preparative Sheet provides information about the informed consent process. It will prepare you for the information you should hear when your doctor, or the interpreter explains the clinical trial and reviews the informed consent with you.
You can take the Verbal Translation Preparative Sheet and the informed consent form with you to take time to think about whether or not you would like to participate in the clinical trial.
Signing the Form
If you want to participate in a clinical trial after learning all that is involved and what you would be expected to do, then you, the trial’s principal investigator (or nurse, if called for in the protocol) and a witness will sign and date the informed consent form. A copy of the form will be given to you.
The informed consent process does not end once you sign the form. If new benefits, risks or side effects are found during a trial, the doctor must inform all of the participants in the trial.You will be encouraged to keep asking questions throughout the trial.
We will take appropriate steps to keep your personal information private. However, there is no guarantee of absolute privacy. The Food and Drug Administration (FDA), the IRB of Frederick Memorial Hospital and the clinical trial’s sponsor might review your record to collect data or to see that the research is being done safely and correctly. Under certain circumstances, the FDA could be required to reveal the names of participants.
