Clinical Trials
Miami Beach Community Health Center has partnered with Community Medical Research to bring the benefits of clinical research participation to our patients. The Medical Directors of CMR are Dr. Mark Rabinowitz, the Chief Medical Officer of MBCHC and Dr. Jeffrey Rosen, a family physician with 27 years of experience in clinical research having successfully completed more than 500 studies enrolling over 6,000 patients.
The following will explain what clinical research is, why you should participate and answer many of your questions. If you are interested in participating in clinical research or have any questions about it please contact Community Medical Research at (305) 866-8915.
What is a clinical trial?
A clinical trial (also called clinical research) is a research study in human volunteers to answer specific health questions. Carefully conducted clinical trials are the fastest and safest way to find treatments that work in people and ways to improve health. Interventional trials determine whether experimental treatments or new ways of using known therapies are safe and effective under controlled environments. Observational trials address health issues in large groups of people or populations in natural settings.
Why participate in a clinical trial?
If you have ever taken medicine, then you have most likely benefited from someone else taking the time and making the effort to volunteer for a clinical trial. Scientists are working to improve medications and treatments, but no medical treatment can improve without research and volunteers. No one wants to be diagnosed as ill, but we all want a successful treatment when a diagnosis occurs. By volunteering you can help advance knowledge about future treatments that someday you or a loved one may benefit from.
In addition to helping others, participation in a clinical study may benefit you. In a research study you have the ability to take an active role in your own health and access a possible investigational medication that is not otherwise available. No treatment may reach clinical testing unless there is evidence that there might be an improvement over current therapies. Participants often benefit from the added care and attention a clinical study offers.
In clinical research, all investigational-related care and medications are provided at no cost to the patient. Along with the investigational-related labs, medications, and exams most studies also offer compensation to the participants in return for their time and travel.
Participants in clinical trials can play a more active role in their 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. Using inclusion/exclusion criteria is an important principle of medical research that helps to produce reliable results. The factors that allow someone to participate in a clinical trial are called "inclusion criteria" and those that disallow someone from participating are called "exclusion criteria". These criteria are based on such factors as age, gender, the type and stage of a disease, previous treatment history, and other medical conditions. Before joining a clinical trial, a participant 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 inclusion and exclusion criteria are not used to reject people personally. Instead, the criteria are used to identify appropriate participants and keep them safe. The criteria help ensure that researchers will be able to answer the questions they plan to study.
What happens during a clinical trial?
The clinical trial process depends on the kind of trial being conducted (See What are the different types of clinical trials?) The clinical trial team includes doctors and nurses as well as social workers and other health care professionals. They check the health of the participant at the beginning of the trial, give specific instructions for participating in the trial, monitor the participant carefully during the trial, and stay in touch after the trial is completed._Some clinical trials involve more tests and doctor visits than the participant would normally have for an illness or condition. For all types of trials, the participant works with a research team. Clinical trial participation is most successful when the 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. It is also a continuing process throughout the study to provide information for participants. To help someone decide whether or not to participate, the doctors and nurses involved in the trial explain the details of the study. If the participant's native language is not English, translation assistance can be provided. 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 participant then decides whether or not to sign the document. Informed consent is not a contract, and the participant may withdraw from the trial at any time.
What are the benefits of participating in a clinical trial?
Clinical trials that are well-designed and well-executed are the best approach for eligible participants to:
- Play an active role in their own health care.
- Gain access to new research treatments before they are widely available.
- Help others by contributing to medical research.
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 the participants. The trial follows a carefully controlled protocol, a study plan which 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. Individual participants' names will remain secret and will not be mentioned in these reports (See Confidentiality Regarding Trial Participants).
What should people consider before participating in a trial?
People should know as much as possible about the clinical trial and feel comfortable asking the members of the health care team questions about it, the care expected while in a trial, and the cost of the trial. The following questions might be helpful for the participant to discuss with the health care team. Some of the answers to these questions are found in the informed consent document.
- What is the purpose of the study?
Who is going to be in the study?
- Why do researchers believe the new treatment being tested may be effective? Has it been tested before?
- What kinds of tests and treatments are involved? How do the possible risks, side effects, and benefits in the study compare with my current treatment?
- How might this trial affect my daily life?
- How long will the trial last?
- Will hospitalization be required?
- Who will pay for the treatment?
- Will I be reimbursed for other expenses?
- What type of long-term follow up care is part of this study?
- How will I know that the treatment is working?
- Will results of the trials be provided to me?
- Who will be in charge of my care?
- Diabetes Mellitus If you have Diabetes Type 2 you might be eligible to participate in this study. Your diabetes must be NOT adequately controlled with diet and exercise alone, and/or metformin.
- This study involves 14 clinic visits in a 18-week period.
- You will receive study-related acre and investigational medication at no cost to you.
- Human Papiloma Virus (HPV) Vaccine If you have children between the ages of 11 to 15 years they might benefit from an investigational vaccine that prevents multiple infections cause by the HPV.
- Infant Formula If you have an infant (15 days old or younger), your baby may qualify for an infant formula study.
For any of these trials, call 305.866.8915 to obtain more information.
Previous Studies:
1. Zostavax Vaccine to prevent shingles
2. H1N1 Vaccine to prevent H1N1 flu or swine flu
3. Human Papiloma Virus (HPV) and PAP Smear Detection of HPV during screening PAP smears
