Clinical research studies are research studies in which patients help physicians and scientists find ways to improve health and cancer care. Each study tries to answer scientific questions and to find better ways to prevent, diagnose, or treat cancer, and help advance the understanding of cancer and its impact. Sylvester conducts a wide range of clinical research studies and currently has 160 therapeutic clinical trials (intervention studies) underway.
What Are the Different Types of Clinical Research Studies?
There are two types of clinical research studies: intervention studies (Clinical Trials) and non-intervention studies (Clinical Research).
Clinical Trials (intervention studies) – enroll patients and provide a specific treatment (therapeutic) or intervention to the patients to study its impact and effectiveness on cancer. Examples of these intervention clinical trials are:
- Prevention Trials – Test new approaches, such as medicines, vitamins, minerals, or other supplements that doctors believe may lower the risk of a certain type of cancer. 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 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 a new cancer drug, new approaches to surgery or radiation therapy, new combinations of treatments, or new methods such as gene therapy).
- Coping with Cancer Trials (also called quality of life or supportive care trials) – Explore ways to improve comfort and quality of life for cancer patients by evaluating ways of helping with the side effects of treatments.
Clinical Research (non-intervention studies) – do not provide a treatment to patients (non-therapeutic), but instead study important factors which help advance the understanding of cancer and its impact. Non-intervention (non-therapeutic) studies often lead to therapeutic ones. 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
Why Are There Clinical Trials?
A clinical trial is one of the final stages of a long 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 laboratory and in laboratory animal. Treatments that show the most promise in these early experiments are studied in clinical trials in patients. Studies are done with cancer patients to find out whether promising approaches to cancer prevention, diagnosis, and treatment are safe and effective. Participation in a clinical trial is strictly voluntary.
Clinical Trials: the Clinical Research Process
Clinical Trial Protocol Review
Clinical trials are conducted according to a protocol plan carefully 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 (inclusion criteria) and who will be excluded (exclusion criteria); details about schedule of tests, procedures and medications and their dosages; the length of the trial; the type of information that will be collected and the end points.
A clinical study is led by a principal investigator, who is often a physician. He or she runs the clinical trial and makes sure that the health team follows the plan. Members of the research team regularly monitor the participants’ health 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 that the risks are minimal and are worth any potential benefits. An IRB is an independent committee that consists of physicians, statisticians, and other members of the community who ensure that 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 institutions in the United States that conduct or support biomedical research involving people to have an IRB initially approve and periodically review the research. It is beneficial to understand that each trial is reviewed many times by different experts before being started at a treatment center.
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 both to protect patient volunteers and to preserve the integrity of the science.
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 whether to participate. The process of informed consent continues providing information updates to enrolled participants during the course of the study. Members of the research team explain the details of the study to help individuals decide whether or not to participate. 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 further 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 to 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 within the University of Miami 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.
An institutional clinical trial is defined for purposes of this plan 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).
What Are the Phases of Clinical Trials?
Most clinical research that involves the testing of a new drug progresses in an orderly series of steps, called phases. This allows physicians 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. In addition, this phase assesses the best way to administer treatment (by mouth, injected into the blood, or injected into the muscle). A phase I trial usually enrolls only 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, 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 – These studies use the results from Phase I trials regarding maximum tolerated dosages and does-limited toxicities. Phase II trials continue to test the safety of the drug, and begins to evaluate how well the new drug works. Treatment is targeted at the population of volunteer patients which responded most favorably in Phase I. Usually, only a small number of patients participate in Phase II trials, focused on a particular type of cancer.
- Phase III Trials – Test a promising new drug, a new combination of drugs, or a new surgical procedure that may increase cure rates or decrease side effects or late effects of treatment in comparison to the current standard. A participant will be 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 – Include the continuing 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), to find more information about long-term side effects.
Phase 1 Clinical Trials Program at Sylvester
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 laboratory into the clinic for patient care. The Phase I Clinical Trials Program at Sylvester was created to fulfill this philosophy within a safe environment to provide patient care.
The program is comprised of a multidisciplinary team of physicians, scientists, pharmacists, laboratory technicians, nurses, statisticians, research coordinators, and data managers. This team has dedicated laboratory, pharmacy, and chemotherapy administration areas, which all work together to provide the highest standard of care to patients who participate in Phase I trials.
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 physicians 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 also has alex’s place, the only Pediatric Phase I Clinical Trials Program in South Florida, and the goal is to foster more collaboration between Sylvester scientists and pediatric oncologists. More than simply 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.
To search for specific cancer clinical trials, click » HERE » and Browse by Division/Therapeutic Area.
For information on pediatric cancer and alex’s place, click » HERE »
What Are the Benefits of Participating in a Clinical Trial?
Here are some benefits you could receive as a clinical trial subject:
- Access to promising drugs, medical devices, or treatment approaches before the general public
- 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. Many people with cancer are now living longer because of what was learned from past clinical trials. And if you decide to participate in a clinical trial at Sylvester, you will play in important role in advancing scientific knowledge and helping future cancer patients.
What Happens After A Clinical Trial Is Completed?
Once a clinical trial is completed, the information collected during the study is carefully examined by the principal investigator and the research team to make decisions about 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 particularly 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 is published to ensure that the analysis and conclusions are sound. Once a new approach has been 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. Published results for a clinical trial study are generally available in the National Library of Medicine’s PubMed database by searching for the official name of the study or for the Protocol ID number.
How Can I Find Clinical Trials for My Type of Cancer?
Visit the UHealth Clinical Trials website to search for clinical trials by diagnosis, physician, trial number, or keyword.
For more information on available cancer studies, speak to your patient care coordinator or call the Sylvester Information Center at 305-243-1000 or 800-545-2292.
Sylvester is a member of Florida Cancer Trials, which strives to increase the number of Floridians participating in cancer clinical trials.
Learn More About Clinical Trials
Cancer.Net from ASCO: About Clinical Trials
Coalition of Cancer Cooperative Groups
American Cancer Society: What You Need to Know About Clinical Trials
Myths & Facts about Cancer Clinical Trials – Coalition of Cancer Cooperative Groups
Cost of Clinical Trials – National Cancer Institute
Clinical Trials and Insurance Coverage – National Cancer Institute
States That Require Health Plans to Cover Patient Care Costs in Clinical Trials
Clinical Trials Home Page
Glossary of related terms