Clinical trials evaluate new medications and therapies before they are approved for use in the general population. Amid concerns about the safety of participants, Sharon Smith, RN, BSN, CDE, Director of Recruitment at Jacksonville Center for Clinical Research, explains the many reasons why people choose to participate: "Clinical trials move medicine forward. Patients who participate in clinical research receive many advantages including treatment at no cost, physician expertise, and access to resources such as expensive tests. Research volunteers shape the future and can have fun while helping others and themselves."
The vast majority of those who participate have positive experiences, says Smith, "In fact, 98% of people who participate in their first clinical trial state their willingness to participate in another study." She lists the reasons why people choose to participate in clinical research studies.
- Connectivity with physician and research center staff
- Possible relief from suffering
- Legacy: altruistic element where they are giving something back to the community
- Helping advance science and the treatment of disease
- Helping others who may suffer from the same disease
- The amount of care and attention the patients receive
- The information that they learn about their disease
- Free medical procedures, diagnostics, and care that they receive
There is no cost to participants for clinical research, as all expenses are paid for by research grants. In most cases, says Smith, there is a stipend for the participant, as well as free treatment for the condition being studied. Clinical trials are funded by study grants from pharmaceutical companies, governments and foundations. The Jacksonville Center for Clinical Research has conducted more than 1,000 clinical trials over 20 years and has gained worldwide recognition.
"Current projects", says Smith, "... cover many therapeutic areas, including cholesterol, Alzheimers and memory loss, diabetes, migraines, osteoarthritis of the knee and hip, hypertension, congestive heart failure, angina, C. Difficile, and COPD. Our studies in these various medical modalities have contributed to brand new treatments, such as PCSK9s (injectable medicines for cholesterol that were approved by the FDA in the fall of 2015). Our CEO, Dr. Michael Koren, is a lead investigator in many of our studies and is a global speaker on PCSK9s. We have also recently begun several Phase 1 studies, some of which may involve overnight stays at JCCR. These studies involve more intense monitoring and testing and also reimburse the patient at a higher level than other studies."
The safety of participants is a primary concern for researchers as well, Smith adds: "Patient safety is our number one concern. As a proven research organization, we take every precaution to assure the safety of our research volunteers. Qualified doctors, nurses and study coordinators are on staff to provide support and care throughout the research trial. Participation is always voluntary, and we appreciate the time and effort that research subjects bring to this important process." Studies can last from a few weeks to years. Participants know in advance how long the study will last, and they are free to withdraw at any time if they choose.
Jacksonville Center for Clinical Research is a member of Encore Research, a network of sites in Jacksonville, Fleming Island, St Johns County, Jacksonville Westside, and the Nature Coast.
They sponsor regular "Learn with the Leaders" sessions which involve expert physicians speaking on health issues (ex: cholesterol, diabetes, heart disease, COPD, etc). These events are no cost, open to the public, and provide a complimentary lunch. Go to their website www.jaxresearch.com to see the schedule and call or email to reserve your spot!