Oncology Referral Network of America - ORNOA
Clinical Trials

 

A clinical trial is a type of research study that tests how well medical approaches work in people. These studies test new methods of screening, prevention, diagnosis, or treatment of disease also called a clinical study.

The benefits of participating in a clinical trial include the following:

  1. Participants have access to promising new approaches that are often not available outside the clinical trial setting.
  2. The approach being studied may be more effective than the standard approach.
  3. Participants receive regular and careful medical attention from a research team that includes doctors and other health professionals.
  4. Participants may be the first to benefit from the new method under study.
  5. Results from the study may help others in the future.
ORNOA - Clinical Trials Current Clinical Trials (click here) (PDF format)

How ORNOA can help?

There are over 50 plus active clinical trials being conducted by our Network physicians in South Florida and many more throughout Florida and in the United States. These studies are sponsored by the International Review Board (IRB) which approves all studies in the United States. Clinical trials have specific requirements for participation, and depending on who is sponsoring the research sometimes are limited to patients that live in the United States. ORNOA searches for appropriately cancer clinical trials and learns of their requirements, and shares this information with patients for their consideration.

Some points to consider:

Clinical trials are research studies that test how well new medical approaches work in people. Each study answers specific questions and tries to find better ways to prevent, screen for, diagnose, or treat a disease. People who take part in cancer clinical trials have an opportunity to contribute to knowledge of, and progress against cancer. They also receive up-to-date care from experts.

There are several types of clinical trials:

Prevention trials test new approaches, such as medications, vitamins, or other supplements, that doctors believe may lower the risk of developing a certain type of cancer. Most prevention trials are conducted with healthy people who have not had cancer. Some trials are conducted with people who have had cancer and want to prevent recurrence (return of cancer), or reduce the chance of developing a new type of cancer.
Screening trials study ways to detect cancer earlier. They are often conducted to determine whether finding cancer before it causes symptoms decreases the chance of dying from the disease. These trials involve people who do not have any symptoms of cancer.

Diagnostic trials study tests or procedures that could be used to identify cancer more accurately. Diagnostic trials usually include people who have signs or symptoms of cancer.

Treatment trials are conducted with people who have cancer. They are designed to answer specific questions about, and evaluate the effectiveness of, a new treatment or a new way of using a standard of treatment. These trials test many types of treatments, such as new drugs, vaccines, new approaches to surgery or radiation therapy, or new combinations of treatments.

Quality-of-life (also called supportive care) trials explore ways to improve the comfort and quality of life of cancer patients and cancer survivors. These trials may study ways to help people who are experiencing nausea, vomiting, sleep disorders, depression, or other effects from cancer or its treatment.

Genetics studies are sometimes part of another cancer clinical trial. The genetic component of the trial may focus on how genetic makeup can affect detection, diagnosis, or response to cancer treatment.

Population- and family-based genetic research studies differ from traditional cancer clinical trials. In these studies, researchers look at tissue or blood samples, generally from families or large groups of people, to find genetic changes that are associated with cancer. People who participate in genetics studies may or may not have cancer, depending on the study. The goal of these studies is to help understand the role of genes in the development of cancer.

Eligibility criteria is important:

Each study's protocol has guidelines for who can or cannot participate in the study. These guidelines, called eligibility criteria, describe characteristics that must be shared by all participants. The criteria differ from study to study. They may include age, gender, medical history, geography and current health status. Eligibility criteria for treatment studies often require that patients have a particular type and stage of cancer.

Enrolling participants with similar characteristics helps to ensure that the results of the trial will be due to what is under study and not other factors. In this way, eligibility criteria help researchers achieve accurate and meaningful results. These criteria also minimize the risk of a person's condition becoming worse by participating in the study.

Informed consent is a process by which people learn the important facts about a clinical trial to help them decide whether to participate. This information includes details about what is involved, such as the purpose of the study, the tests and other procedures used in the study, and the possible risks and benefits. In addition to talking with the doctor or nurse, people receive a written consent form explaining the study. People who agree to take part in the study are asked to sign the informed consent form. However, signing the form does not mean people must stay in the study. People can leave the study at any time—either before the study starts or at any time during the study or the follow-up period.

The informed consent process continues throughout the study. If new benefits, risks, or side effects are discovered during the study, the researchers must inform the participants. They may be asked to sign new consent forms if they want to stay in the study.

Location of clinical trials can take place in doctors’ offices, cancer centers, other medical centers, community hospitals and clinics, and veterans’ and military hospitals in cities and towns across the United States and in other countries. Clinical trials may include participants at one or two highly specialized centers, or they may involve hundreds of locations at the same time.

Phases of clinical trials:

Clinical trials are usually conducted in a series of steps, called phases. Many treatment clinical trials are always assigned a phase. However, screening, prevention, diagnostic, and quality-of-life studies do not always have a phase. Genetics clinical trials generally do not have a phase.

Phase I trials are the first step in testing a new approach in people. In these studies, researchers evaluate what does is safe, how a new agent should be given (by mouth, injected into a vein, or injected into the muscle), and how often. Researchers watch closely for any harmful side effects. Phase I trials usually enroll a small number of patients and take place at only a few locations. The dose of the new therapy or technique is increased a little at a time. The highest dose with an acceptable level of side effects is determined to be appropriate for further testing.

Phase II trials study the safety and effectiveness of an agent or intervention, and evaluate how it affects the human body. Phase II studies usually focus on a particular type of cancer, and include fewer than 100 patients.

Phase III trials compare a new agent or intervention (or new use of a standard one) with the current standard therapy. Participants are randomly assigned to the standard group or the new group, usually by computer. This method, called randomization, helps to avoid bias and ensures that human choices or other factors do not affect the study's results. In most cases, studies move into phase III testing only after they have shown promise in phases I and II. Phase III trials often include large numbers of people across the country.

Phase IV trials are conducted to further evaluate the long-term safety and effectiveness of a treatment. They usually take place after the treatment has been approved for standard use. Several hundred to several thousand people may take part in a phase IV study. These studies are less common than phase I, II, or III trials.

People who participate in a clinical trial work with a research team. Team members may include doctors, nurses, social workers, dietitians, and other health professionals. The health care team provides care, monitors participants’ health, and offers specific instructions about the study. So that the trial results are as reliable as possible, it is important for participants to follow the research team's instructions. The instructions may include keeping logs or answering questionnaires. The research team may continue to contact participants after the trial ends.

The possible risks of participating in a clinical trial include the following:

Costs associated with a clinical trial:

Health insurance and managed care providers often do not cover the patient care costs associated with a clinical trial. What they cover varies by health plan and by study. Some health plans do not cover clinical trials if they consider the approach being studied “experimental“ or “investigational”. However, if enough data show that the approach is safe and effective, a health plan may consider the approach “established” and cover some or all of the costs. Participants may have difficulty obtaining coverage for costs associated with prevention and screening clinical trials; health plans are currently less likely to have review processes in place for these studies. It may, therefore, be more difficult to get coverage for the costs associated with them. In many cases, it helps to have someone from the research team talk about coverage with representatives of the health plan.

Health plans may specify other criteria a trial must meet to be covered. The trial might have to be sponsored by a specified organization, be judged “medically necessary” by the health plan, not be significantly more expensive than treatments the health plan considers standard, or focus on types of cancer for which no standard treatments are available. In addition, the facility and medical staff might have to meet the plan's qualifications for conducting certain procedures, such as bone marrow transplants.

After a clinical trial is completed, the researchers look carefully at the data collected during the trial before making decisions about the meaning of the findings and further testing. After a phase I or II trial, the researchers decide whether to move on to the next phase, or stop testing the agent or intervention because it was not safe or effective. When a phase III trial is completed, the researchers look at the data and decide whether the results have medical importance.

The results of clinical trials are often published in peer-reviewed, scientific journals. Peer review is a process by which experts review the report before it is published to make sure the analysis and conclusions are sound. If the results are particularly important, they may be featured by the media and discussed at scientific meetings and by patient advocacy groups before they are published. Once a new approach has been proven safe and effective in a clinical trial, it may become standard practice. (Standard practice is a currently accepted and widely used approach.)