Visit the UHealth Clinical Trials website to search for clinical trials by diagnosis, doctor, trial number, or keyword.

An interventional clinical trial is one of the final stages of a lengthy and careful cancer research process. Cancer researchers begin clinical trials of new drugs only after they have tested them in cancer cells grown in the lab and in lab animals. Treatments that show the most promise in these early experiments are studied in clinical trial participants.

Studies with cancer patients help researchers determine if promising approaches to cancer prevention, diagnosis, and treatment are safe and effective. Participation in a clinical trial is strictly voluntary.

Involvement in a clinical trial is strictly voluntary. If you participate, you can experience benefits such as:

• Access to promising drugs, medical devices, or treatment approaches before they are widely available
• Free or subsidized health care for the duration of the trial
• A more active role in your own health care
• Expert medical care at a leading health care facility
• Close monitoring of your health care and side effects

Clinical trials have played an important role in the fight against cancer. Participating in a clinical research intervention study contributes to medical knowledge. Many people with cancer are now living longer because of what was learned from past clinical trials. If you decide to participate in a clinical trial at UHealth, you will play in important role in advancing scientific knowledge and helping future cancer patients.

There are two types of clinical research studies: intervention studies (clinical trials or interventional clinical trials) and non-intervention studies (clinical research).

Interventional clinical trials enroll patients and provide a specific treatment or intervention to the patients to study its impact and effectiveness on cancer. Examples of interventional clinical trials are:

• Prevention trials: Test new approaches that doctors believe may lower the risk of a certain type of cancer, such as medicines, vitamins, minerals, or other supplements. These trials look for the best way to prevent cancer in people who have never had cancer, or to prevent cancer from coming back or a new cancer from occurring in people who have already had cancer.
• Screening trials: Test the best way to find or locate cancer, especially in its early stages.
• Diagnosis trials: Test new methods for diagnosing cancer.
• Treatment trials: Test new treatments — like cancer drugs, surgical or radiation therapy approaches, combinations of treatments, or methods like gene therapy.
• Coping with cancer trials: Explore ways to improve comfort and quality of life for cancer patients by evaluating ways to help with treatment side effects. These studies are also called quality of life or supportive care trials.

Non-interventional clinical research doesn’t provide a treatment to patients, but instead studies important factors that help advance our understanding of cancer and its impact. However, non-intervention studies often lead to therapeutic studies. Examples of non-therapeutic research trials are:

• Collection of tissue specimens to examine the cellular structure of a cancer tumor
• Studies that track epidemiological information, such as the long-term health effects of chemotherapy

Clinical Trial Protocol Review
Clinical trials are conducted according to a protocol plan designed to safeguard the health of the volunteer participants while aiming to answer specific research questions. The protocol includes the following information:

• Purpose of the study
• How many people will participate
• Who is eligible to participate in the study, and who will be excluded
• Details about schedule of tests, procedures, and medications, and their dosages
• The length of the trial
• The type of information that will be collected
• The end points

A clinical study is led by a principal investigator (PI), who is often a doctor. The PI runs the clinical trial and makes sure the health team follows the plan. Members of the research team monitor the participants’ health regularly to determine the study’s safety and effectiveness.

Each clinical trial in the United States must be approved and monitored by an Institutional Review Board (IRB) to ensure the risks are minimal and are worth any potential benefits. An IRB is an independent committee of doctors, statisticians, and other members of the community that ensure clinical trials are ethical and that the rights of participants are protected.

A variety of experts review the trial before it is sent to the National Cancer Institute (NCI) for approval. Federal regulation requires all U.S. institutions that conduct or support biomedical research involving people have an IRB initially approve and periodically review the research. Each trial is reviewed many times by different experts before it’s started at a treatment center.

Ethical Guidelines
The goal of clinical research is to develop knowledge that improves human health or advances our understanding of human biology. People who participate in clinical research make this possible. The path to finding out if a new drug or a new treatment is safe or effective is to test it on patient volunteers. The purpose of ethical guidelines is to protect patient volunteers and preserve the integrity of the science.

Informed Consent
Before joining a clinical trial, a participant must qualify for the study. Some research studies seek participants with the illnesses or conditions to be studied in the clinical trial, while others need healthy volunteers. Informed consent is the process of providing potential volunteer participants with the main details about a clinical trial before they decide to participate. The process of informed consent continues providing information updates to enrolled participants during the course of the study. Translation or interpretation assistance can be provided for participants with limited English proficiency.

The research team provides an informed consent document that includes study details, such as study purpose, duration, required procedures, risks and potential benefits, alternatives to the study, and who to contact for more information. The participant then decides whether to sign the document.

Informed consent is not a contract, and volunteers are free to withdraw from the study completely or refuse particular treatments or tests at any time. However, refusing treatment will sometimes make them ineligible to continue the study.

Data Safety and Monitoring Plan
Sylvester functions as a matrix cancer center, which means it resides within and is part of the University of Miami and Miller School of Medicine. All clinical trials conducted at Sylvester must include provisions for data and safety monitoring. The extent of monitoring may vary based on the degree of risk, the sponsor, and the size and complexity of the trial.

The cancer center has developed the Data Safety and Monitoring Plan to ensure data and safety monitoring, as well as protocol compliance, for all institutional clinical trials involving therapeutic or preventive interventions.

For purposes of this plan, an institutional clinical trial is defined as a clinical trial initiated and conducted by a member of the University of Miami faculty or staff, not subject to monitoring by an outside agency (e.g., industry, cooperative group, NCI, NIH, other institution).

Most clinical research that involves the testing of a new drug progresses in an orderly series of steps, called phases. This allows doctors and scientists to ask and answer questions in a way that results in reliable information about the drug and protects the patients. Clinical trials are usually classified into one of four phases:

Phase I trials: Evaluate how a new drug can be provided safely, including proper dosing and potential side effects. This phase also assesses the best way to administer treatment, such as by mouth, injected into the blood, or injected into the muscle. Usually, a phase I trial enrolls a small number of patients or healthy volunteers — sometimes, as few as a dozen. Phase I trials are the first studies in humans, and, as a result, are an important step to transition novel treatments from the bench to the bedside. The Phase I Clinical Trials Program at Sylvester helps doctors and scientists establish collaborative relationships that often translate into more treatment choices for patients.

Phase II trials: Use the results from Phase I trials regarding maximum tolerated dosages and dose-limited toxicities. Phase II trials continue to test the safety of the drug and begin to evaluate how well the new drug works. Treatment is targeted at the population of volunteer patients that responded most favorably in Phase I. Usually, only a small number of patients participate in Phase II trials, which are focused on a particular type of cancer.

Phase III trials: This type of trial may test a promising new drug or a new combination of drugs. It may also test a new surgical procedure that may increase cure rates or decrease side effects or late effects of treatment. A participant is assigned to the standard group or the new group at random, called randomization. Phase III trials often enroll large numbers of patients and may be conducted at many doctors’ offices, clinics, and cancer centers nationwide.

Phase IV trials: Continue evaluation that takes place after FDA (Food and Drug Administration) approval, when the drug is already on the market and available for general use (post-marketing surveillance). These trials gather more information about long-term side effects.

There are two types of clinical research studies: intervention studies (clinical trials or interventional clinical trials) and non-intervention studies (clinical research).

The National Institutes of Health Roadmap for Medical Research calls for providing “the necessary foundation for advancing basic and clinical research” to speed promising therapies from the lab into the clinic for patient care. Our Phase I Clinical Trials Program was created to fulfill this philosophy within a safe environment for patient care.

The program includes a multidisciplinary team of doctors, scientists, pharmacists, lab technicians, nurses, statisticians, research coordinators, and data managers. The team has dedicated lab, pharmacy, and chemotherapy administration staff that all work together to provide the highest standard of care to Phase I trial participants.

Phase I trials are the first studies in humans, and, as a result, an important step to transition novel treatments from the bench to the bedside. The Phase I Clinical Trials Program helps doctors and scientists establish collaborative relationships that often translate into more treatment choices for patients:

• The Phase I Clinical Trials Program at Sylvester is South Florida’s only academic Phase I testing center dedicated to drug development for cancer patients.
• Sylvester has the only Pediatric Phase I Clinical Trials Program in South Florida, which fosters more collaboration between Sylvester scientists and pediatric oncologists. Sylvester is also home to alex’s place. More than a treatment site for children with cancer and blood diseases, alex’s place is a space designed to empower our young patients and support their families.

Once a clinical trial is completed, the information collected during the study is examined carefully by the principal investigator and the research team to determine the meaning of the findings and the potential need for further testing.

When a Phase I or II trial is completed, the investigators decide to move on to the next phase or to stop the study because the drug or intervention being tested was determined to be unsafe or ineffective.

After a Phase III trial is completed, researchers scrutinize the data to decide if the results have medical significance. If the results are important, they may be featured in news media and discussed at scientific meetings and by patient advocacy groups before they are published.

Results from clinical trials and non-intervention research studies are often published in peer-reviewed scientific journals. Peer review is a process by which experts review the report before it’s published to ensure the analysis and conclusions are sound. Once a new approach is proven safe and effective in a clinical trial, it may become the standard of medical practice. Ask the research team investigators if the study results will be published. Usually, a clinical trial’s published results are available in the National Library of Medicine’s PubMed database. You can search for the study using the official name of the study or the Protocol ID number.

You can visit the following websites for more information about clinical trials:

• ASCO Cancer.Net
• Cancertrialshelp.org
• EmergingMed
• What You Need to Know About Clinical Trial (American Cancer Society)
• Cost of Clinical Trials (National Cancer Institute)
• Insurance Coverage and Clinical Trials (National Cancer Institute)
• Dictionary of Cancer Terms (National Cancer Institute)
• States That Require Health Plans to Cover Patient Care Costs in Clinical Trials
• National Cancer Institute Clinical Trials Home Page