FAQs

This information is provided by clinicaltrials.gov and is used here with permission of the National Medical Library and their content policies.

What is a clinical trial?

Although there are many definitions of clinical trials, they are generally considered to be biomedical or health-related research studies in human beings that follow a pre-defined protocol. Redwood Regional Medical Group offers both interventional and observational types of studies. In interventional studies research subjects are assigned by the investigator to a treatment or other intervention, and their outcomes are measured. In observational studies individuals are observed and their outcomes are measured by the investigators.

Why participate in a clinical trial?

By participating in clinical trials you can play a more active role in your own health care, gain access to new research treatments before they are widely available, and help others by contributing to medical research.

Who can participate in a clinical trial?

All clinical trials have guidelines about who can participate. The factors that allow you to participate in a clinical trial are called "inclusion criteria" and those that disallow you from participating are called "exclusion criteria". These criteria are based on such factors as your age, gender, the type and stage of a disease, previous treatment history, and other medical conditions. Before joining a clinical trial, you must qualify for the study. Some research studies seek participants with illnesses or conditions to be studied in the clinical trial, while others need healthy participants. It is important to note that your inclusion and exclusion criteria are not used to reject you personally. Instead, the criteria are used to identify if you are a qualified participant. The criteria help ensure that researchers will be able to answer the questions they plan to study and to keep you safe.

What happens during a clinical trial?

The clinical trial process depends on the type of trial being conducted. The clinical trial team includes doctors and nurses as well as social workers and other health care professionals. They check your health at the beginning of the trial, give you specific instructions for participating in the trial, monitor you carefully during the trial, and stay in touch after the trial is completed. Some clinical trials involve more tests and doctor visits than you would normally have for an illness or condition. For all types of trials, you work with a research team. Clinical trial participation is most successful when the trial protocol is carefully followed and there is frequent contact with the research staff.

What is informed consent?

Informed consent is the process of learning the key facts about a clinical trial before deciding whether or not to participate. The process continues throughout the study to provide you information. To help you and your family decide whether or not to participate, the doctors and nurses involved in the trial explain the details of the study. Then the research team provides an informed consent document that includes details about the study, such as its purpose, duration, required procedures, and key contacts. Risks and potential benefits are explained in the informed consent document. The informed consent document is not a contract, and you may withdraw from the trial at any time.

What are side effects and adverse reactions?

Side effects are any undesired actions or effects of the experimental drug or treatment. Negative or adverse effects may include headache, nausea, hair loss, skin irritation, or other physical problems. Experimental treatments must be evaluated for both immediate and long-term side effects.

How is the safety of the participant protected?

The ethical and legal codes that govern medical practice also apply to clinical trials. In addition, most clinical research is federally regulated with built in safeguards to protect participants. All clinical trials follow a carefully controlled protocol, a study plan which that details what researchers will do in the study. As a clinical trial progresses, researchers report the results of the trial at scientific meetings, to medical journals, and to various government agencies. Your participation will remain confidential and will not be mentioned in these reports. Every clinical trial in the U.S. must be approved and monitored by an Institutional Review Board (IRB) to ensure the risks are as low as possible and are worth any potential benefits. An IRB is an independent committee of physicians, statisticians, community advocates, and others that ensures that a clinical trial is ethical, and the rights of study participants are protected. All institutions that conduct or support biomedical research involving people must, by federal regulation, have an IRB that initially approves and periodically reviews the research.

What should you consider before participating in a trial?

You should know as much as possible about the clinical trial and feel comfortable asking the members of the health care team questions about it. You should have a clear understanding of the care expected while in a trial, and the cost of the trial. The following questions might be helpful for you to discuss with our research team. Some of the answers to these questions are found in the informed consent document.

Plan ahead and write down possible questions to ask. Ask a friend or relative to come along for support and to hear the responses to the questions.

Does a participant continue to work with a primary health care provider while in a trial?

Yes. Most clinical trials provide short-term treatments related to a designated illness or condition, but do not provide extended or complete primary health care. In addition, by having the health care provider work with the research team, you can be ensured that other medications or treatments will not conflict with the protocol.

Can a participant leave a clinical trial after it has begun?

Yes. You can leave a clinical trial, at any time. When withdrawing from the trial, you should let the research team know about it, and the reasons for leaving the study.

Where do the ideas for trials come from?

Ideas for clinical trials usually come from researchers. After researchers test new therapies or procedures in the laboratory and in animal studies, the experimental treatments with the most promising laboratory results are moved into clinical trials. During a trial, more and more information is gained about an experimental treatment, its risks and how well it may or may not work.

Who sponsors clinical trials?

Clinical trials are sponsored or funded by a variety of organizations or individuals such as physicians, medical institutions, foundations, voluntary groups, and pharmaceutical companies, in addition to federal agencies such as the National Institutes of Health (NIH), the Department of Defense (DOD), and the Department of Veteran's Affairs (VA). Trials can take place in a variety of locations, such as hospitals, universities, doctors' offices, or community clinics.

What is a protocol?

A protocol is a study plan on which all clinical trials are based. The plan is carefully designed to safeguard the health of the participants as well as answer specific research questions. A protocol describes the types of people who should consider participating in the trial; the schedule of tests, procedures, medications, and dosages; and the length of the study. While following a protocol of any clinical trial you will be seen regularly by the research staff to monitor your health and to determine the safety and effectiveness of your treatment.

What is a placebo?

A placebo is an inactive pill, liquid, or powder that has no treatment value.  In clinical trials, investigational treatments are often compared with placebos to assess the investigational treatment's effectiveness.  At RRMG we do not have cancer treatment studies that involve just placebo versus standard or investigational treatment(s).  All cancer treatment studies will compare the standard treatment regimen with or without the investigational drug.  There may be more than two randomized treatment regimens; however all cancer treatment research trial regimens will not contain just a placebo. 

What is a control or control group?

A control is the standard by which experimental observations are evaluated. In many clinical trials, one group of patients will be given an experimental drug or treatment, while the control group is given either a standard treatment for the illness or a placebo. You will not know which group you will be assigned to if you choose to participate in a clinical trial.

What are the different types of clinical trials?

Treatment trials test experimental treatments, new combinations of drugs, or new approaches to surgery or radiation therapy. Prevention trials look for better ways to prevent disease in people who have never had the disease or to prevent a disease from returning. These approaches may include medicines, vitamins, vaccines, minerals, or lifestyle changes. Diagnostic trials are conducted to find better tests or procedures for diagnosing a particular disease or condition. Screening trials test the best way to detect certain diseases or health conditions. Quality of Life trials (or Supportive Care trials) explore ways to improve comfort and the quality of life for individuals with a chronic illness.

What are the phases of clinical trials?

Clinical trials are conducted in phases. The trials at each phase have a different purpose and help scientists answer different questions:

In Phase I trials, researchers test an experimental drug or treatment for the first time in a small group of people (20-80) to evaluate its safety, determine a safe dosage range, and identify side effects.

In Phase II trials, the experimental study drug or treatment is given to a larger group of people (100-300) to see if it is effective and to further evaluate its safety.

In Phase III trials, the experimental study drug or treatment is given to large groups of people (1,000-3,000) to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the experimental drug or treatment to be used safely.

In Phase IV trials, post marketing studies delineate additional information including the drug's risks, benefits, and optimal use.