Romano Law Nurse Corner COVID-19 #20
A Vaccine Trial in Palm Beach County, FL
More and more cases…Palm Beach County, FL is one of the “hot spots” in Florida and nationally for new cases of COVID-19. This is not good news for anyone. However, there is a bit of positive news that has emerged.
Last week, it was announced that Palm Beach County, FL will be the site of a clinical trial for a COVID-19 vaccine in early August! This trial is one of many trials currently going on throughout the country. It is one of 2 two COVID-19 vaccine trials in Florida. This trial will require 1500 volunteers and will be run by JEM Research Institute, one of the sites for Headlands Research, a California based company. Locally their office is near JFK Medical Center in Atlantis, FL. They have chosen Dr. Larry Bush, an infectious disease specialist and research investigator in Wellington, FL as the principal investigator.
Being a hot spot makes Palm Beach County a perfect place for this clinical trial. The country needs a vaccine to put this pandemic behind us, said Dr. Bush. Further, if you are going to be able to show that your vaccine works, you have to be testing in an area where people have a high risk of being infected. The numbers say we are having a serious amount of disease.
What exactly is a clinical study?
A clinical study is research using human volunteers that is intended to add to medical knowledge. A principal investigator, most often a medical doctor, leads each one. Common reasons for conducting clinical studies include:
- Evaluating one or more interventions (for example, drugs, medical devices, approaches to surgery or radiation therapy) for treating a disease, syndrome, or condition
- Finding ways to prevent the initial development or recurrence of a disease or condition. These can include medicines, vaccines, or lifestyle changes, among other approaches.
- Evaluating one or more interventions aimed at identifying or diagnosing a particular disease or condition
- Examining methods for identifying a condition or the risk factors for that condition
- Exploring and measuring ways to improve the comfort and quality of life through supportive care for people with a chronic illness
Clinical studies are often sponsored/funded by pharmaceutical companies, academic medical centers, or other organizations, doctors, health care providers, or individuals in addition to Federal agencies such as the National Institutes of Health, the U.S. Department of Defense, U.S. Department of Veterans Affairs, etc. Oftentimes, there are collaborations between these entities.
Generally, there are two main types of clinical studies.
Clinical trials (interventional studies)-participants receive specific interventions according to a pre-approved protocol. Strict regulations govern clinical trials.
Observational studies-investigators assess health outcomes in groups of participants. These participants are not assigned interventions by the investigator however they may receive interventions in their routine medical care.
The trial here in Palm Beach County is a phase 3 clinical trial.
There are 4 phases of clinical trials.
Phase 1 clinical trial is the first time a new treatment or vaccine is tested in humans. It involves a small number, usually 20-100 healthy volunteers or people with the disease/condition. It usually lasts several months and its main purpose is safety and dosage. These trials are closely monitored to gather information about how the drug interacts with the human body. Researchers adjust dosing schemes based on data and answer questions related to how it works in the body as well as the side effects associated with increased dosage. Phase 1 also provides early information about how effective it is and how to best administer it, all of which are important to design the next phase of studies. Approximately 70% of drugs move to the next phase.
Assuming phase 1 is successful, approval is sought to move to phase 2 trials which involve a larger number of people, up to several hundred. This phase lasts anywhere from several months to 2 years and its purpose is overall efficacy and monitoring side effects. This phase provides researchers with additional safety data to refine further questions, develop research methods and design phase 3 protocols. Approximately 33% of drugs move to the next phase.
Phase 3 studies include 300 to 3,000 participants and last 1 to 4 years. Phase 3 provides most of the safety data. In previous studies, less common side effects could go undetected, however because these are larger and longer studies they are more likely to show up. Approximately 25-30% of drugs move to the next phase.
Phase 4 clinical trials are carried out once the FDA has approved the drug during the Post-Market Safety Monitoring
How will it work?
According to Dr. Bush, half of the participants will be given the vaccine while the other half will get a placebo. Doctors will then wait to see who gets sick, what is the immune response of those getting well and what are the side effects. Since this is a phase 3 trial, these vaccines have already gone through human safety checks in early trials. Dr. Bush says the vaccine of this particular trial is going to be using does not carry a live virus as far as COVID, therefore you cannot get infected with the (virus).
Dr. Bush also said if the trial goes well, it is possible the vaccine could gain government approval early next year.
So, in the midst of this hot spot there is some light of hope for combatting this deadly virus. We must continue to be steadfast in our mask wearing and social distancing, the new norm. My mask protects you, your mask protects me.
We are Susan Ramsey and Amie Goldberg, both practicing attorneys and nurses here at the Romano Law Group. Here is a little more about each of us:
Susan Ramsey is both an attorney and an RN. Ms. Ramsey’s professional experience began as a Registered Nurse in the Intensive Care Unit at Yale New Haven Hospital. While pursuing her Bachelor’s Degree, she was a counselor with the New Haven Rape Crisis Program. During her time with the Program, Ms. Ramsey counseled sexual assault survivors and performed seminars for local police departments, universities, and high schools. During her time working as a registered nurse, Ms. Ramsey decided to attend law school. Ms. Ramsey graduated from CUNY Law School, and has practiced law in several different State and Federal Courts. She is a Florida Heath Care Risk Manager and a member of the Palm Beach County Sober Home Task Force. Ms. Ramsey actively litigates cases involving catastrophic injuries and wrongful death on behalf of survivors, cases include injuries suffered by victims of professional negligence, product liability and medical negligence.
Amie Goldberg is both an attorney and a certified APRN. After completing a Bachelor of Arts Degree at Whittier College, Ms. Goldberg attended nursing school at Emory University. Ms. Goldberg’s professional experience started as a Registered Nurse at Egleston Children’s Hospital taking care of children with congenital heart disease. After a few years, she continued working in all areas of the hospital while attending Kennesaw State University on weekends in order to get her Master’s Degree in Nursing with a specialty of Primary Care Nurse Practitioner/Family Nurse Practitioner. During her time as an APRN, Ms. Goldberg decided to attend law school at St. Thomas University in Miami, Florida. Since graduating, she has mainly practiced in the areas of personal injury and worker’s compensation, fighting for the rights of injured people. Since joining the Romano Law Group, Ms. Goldberg has been the Director of the Opioid Litigation Project. Ms. Goldberg also practices in the area of medical malpractice and nursing home negligence, bringing an inside perspective and knowledge to help get justice for our clients.