Understanding How Clinical Trials Work
Clinical trials are essential to cancer research and are a key component of our mission at Fred Hutch Cancer Center to translate scientific discoveries into the prevention, diagnosis, treatment and cure for cancer and all other diseases we treat.
Without clinical trials, new interventions could not be approved. Fred Hutch has one of the most active clinical trial programs in the world — which provides new hope for our patients every day. Fred Hutch, the University of Washington and Seattle Children's form the only National Cancer Institute-designated Comprehensive Cancer Center in Washington state.
It’s always up to you whether to take part in a clinical trial, also called a clinical study. One potential benefit is that you may be among the first to get access to a promising new treatment. Even if you decide not to participate, the fact that Fred Hutch provides treatment for patients in trials is a good reason to come here for your care.
Clinical Trial Phases
Clinical trials are done in phases to answer questions about effectiveness and safety so that therapies are thoroughly researched before the U.S. Food and Drug Administration (FDA) approves them. Typically, if a therapy is successful in one phase, it will move forward to the next phase, with each phase having more participants.
Phase I (1)
Phase I is typically the first time the treatment is being tested in humans. This phase finds the highest dose of the therapy that people can tolerate, called the maximum tolerated dose. Phase I trials are done in a small group of people. Researchers measure how participants respond and monitor them closely for side effects. While Phase I trials are not designed to see if the therapy works, researchers may get insights into how effective it may be during Phase I.
Fred Hutch provides the first academic-based Phase I program for cancer research in the Pacific Northwest. The Phase 1 Program at Fred Hutch provides a full range of research services to advance the development, implementation and successful completion of clinical trials.
Phase II (2)
After finding the maximum tolerated dose, Phase II shows whether the therapy is effective, and researchers continue to evaluate its safety and side effects. Enrolling hundreds of people of different ages and health statuses, Phase II trials provide detailed data on the body’s response at different dosages.
Phase III (3)
Phase III shows whether the therapy is effective for a larger group of people. It typically involves comparing results for participants randomized to receive either the study therapy or the standard of care. In Phase III trials, researchers continue to evaluate the safety and side effects of the therapy.
Phase IV (4)
Some therapies that are approved by the FDA continue to be researched in Phase IV (post-marketing) clinical trials. In this phase, researchers may monitor the effectiveness, side effects and safety of the therapy over a long period of time and in a larger, more diverse or different group of people than in previous clinical trials.
Clinical Trial
Clinical research involving people, also referred to as human subjects, that is done according to a plan, or protocol, to evaluate biomedical or health-related outcomes. A clinical trial can also be called a clinical study.
Intervention / Therapy
An intervention, or therapy, in a clinical trial is the medicine or method that is being tested for its success in treating or preventing a disease.
Placebo
Something that looks like the medicine being tested but does not have any active ingredient. A sugar pill is a standard type of placebo. Researchers compare the results of the placebo to the results of the intervention being tested. The clinical trials team will tell you in advance if a clinical trial involves a placebo and what your chances are of receiving the placebo. A placebo may not be used in research if it would mean putting people at risk by denying them effective therapy.
Randomization
The process of randomly assigning participants to receive either the therapy, sometimes in different dosages, or a placebo. You cannot choose which group you are assigned to, but the clinical trials team will tell you about your chances of being assigned to one group or the other. Randomization is important to the scientific validity of the study. It eliminates bias to help ensure that differences between the groups’ results are due to the different treatments they received and not caused by other factors.
Blinded
In blinded clinical trials, you will not know which intervention you are receiving.
Double-Blinded
In double-blinded clinical trials, neither you nor the research team will know which intervention you are receiving.
Informed Consent
An informed consent form (ICF) provides details about a clinical trial so you can make an informed decision about participating. It includes information about the purpose of the trial as well as the phase, plan, therapy, tests, procedures, duration, risks, benefits and alternatives. You will have to sign the ICF before beginning study activities. Your signature confirms that the research team explained the study, including possible risks and side effects, and that you had a chance to ask questions. ICFs also state that you can stop participating at any time.
Eligibility Criteria
Eligibility criteria are factors that researchers use to decide if you qualify for a clinical trial. They may include factors like your type and stage of cancer, treatment history, age, gender, medical history and current health. Eligibility criteria help protect you from receiving therapies that may harm you. These criteria also reduce differences among people in the study. This helps ensure that results are due to the study intervention rather than other factors.
Protocol
All clinical trials follow a plan, called the protocol, that includes:
- The reason the research team is doing the study
- Rules about who can join the clinical trial, called eligibility criteria
- The number of people needed for the research
- Information on the therapy and how safe it is
- Schedule and details of tests and evaluations that will be done
- Information that will be collected from participants
- Other information about the specific research project
At Fred Hutch, clinical research protocols go through internal scientific review and clinical review before being submitted for review by an institutional review board (IRB). The IRB is made up of researchers (physicians, nurses and scientists) and laypeople to safeguard the interests of human subjects. It is responsible for making sure your rights and welfare are protected if you take part in the study. The IRB also evaluates proposed clinical research for ethical study practices, proper attention to volunteers’ safety and respect for volunteers’ rights. IRB review is federally required for all clinical trials. No participants may be enrolled in a study until the protocol has been approved by an IRB.
The institutional review board (IRB) that approved a clinical trial continues to monitor the trial while it is in progress. They conduct reviews of the study at least once a year, review any changes to the protocol or the informed consent form and review any new information about the study.
A data and safety monitoring board (DSMB) is an independent committee made up of experts in clinical research that also monitors and reviews the study data periodically to ensure the safety of participants. The DSMB may stop the clinical trial early if safety concerns arise or if the answer to the main research question has been answered.
The U.S. Food and Drug Administration (FDA) also inspects clinical study records and sites to make sure volunteers are protected and clinical trials are being conducted correctly.
Your safety is extremely important to us. We have many safety procedures and practices in place for clinical research. If you enroll in a clinical trial, your rights and safety are protected through the protocol, which undergoes scientific and human subjects protection reviews and approval. Researchers have initial information on the therapy being tested from lab and large animal model studies that take place before human studies begin. The research teams continue to check for possible side effects by monitoring you during the study, and researchers must inform you of any new risks, benefits or side effects they discover.
State, national and international regulations and policies protect the rights, safety and well-being of people in clinical research and ensure that clinical trials are done according to strict scientific and ethical principles. In the United States, the Office of Human Research Protections oversees clinical studies and protects study participants. The U.S. Food and Drug Administration (FDA) has authority over clinical studies of drugs, biologics and medical devices.
Information gained from clinical research is reported at scientific meetings and published in medical journals so that researchers can share results with other professionals. Often, a pharmaceutical company or biotechnology firm that sponsors research will publish the results in a press release and on their website. You will not be mentioned by name in any publication of clinical trials results and your personal and health information is always kept private.