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De-mystifying clinical trials…… 


There are several phases of clinical trials, and it is useful to understand the process and progression. Here is a breakdown of the basics, although there are exceptions and overlap when it comes to final trial design:


Preclinical studies involve laboratory and/or animal investigations of a potential new drug or treatment.  Mode of action and safety are tested extensively before a new drug is approved by the FDA to begin trials in humans.


Phase I trials involve the testing of a new drug or treatment in a small group of people (18-20) for the first time to evaluate safety, determine a safe dose range, and identify side effects. Participants in these studies are often healthy individuals. Phase I studies typically involve a lot of evaluations, tests and monitoring.


In phase II trials, the study drug or treatment is given to a larger group of people (100-300) to see if the therapy is effective, determine best dosing regimen, and to further evaluate safety. Often these are individuals with the particular diagnosis that the drug or treatment is targeting. Phase II trials continue with close monitoring and can also involve lab tests to measure how the investigational drug is metabolized over specific time periods.


Phase III trials are designed to enroll an even larger group of participants (1,000 to 3,000) to confirm effectiveness, monitor side effects, compare it to commonly used treatments, and collect data that will allow the drug or treatment to be used safely. These trials are often placebo-controlled and include patients with other medical problems and medications. Outcome studies typically involve many thousands of subjects over several years to evaluate the end results of a treatment in terms of illness or benefit to society.


After a drug or treatment has FDA-approval, Phase IV trials are conducted to collect additional information, including risks, benefits and optimal use. These are also known as Post-marketing trials.

Posted by Amy Autry Bush Thursday, January 16, 2014 2:33:00 PM Categories: Insider Corner

Investigational Vaccine for Prevention of Clostridium difficile (C. diff) 

Recent news release......

Jacksonville Center for Clinical Research Participates in Phase III Trial of Investigational Vaccine for Prevention of Clostridium difficile (C. diff)


Cdiffense trial to evaluate vaccine against a leading cause

of life-threatening, healthcare-associated infections worldwide


Jacksonville, FL  December 5, 2013 – Jacksonville Center for Clinical Research (JCCR) announced today that it is participating in a clinical study to evaluate the safety, immunogenicity and efficacy of an investigational vaccine for the prevention of primary symptomatic Clostridium difficile (C. diff) infection (CDI). C. diff is a potentially life-threatening, spore-forming bacterium that causes intestinal disease. While most types of healthcare-associated infections (HAIs) are declining, C. diff is emerging as a leading cause of life-threatening, HAIs worldwide. The infection poses the greatest danger for older adults in hospitals or long-term care facilities who take broad-spectrum antibiotics.[i]

JCCR joins more than 200 sites across 17 countries from around the world in the Cdiffense clinical trial, a Phase III randomized, observer-blind, placebo-controlled study. Volunteers for the study should be age 50 or older and planning an upcoming hospitalization of more than 72 hours for a surgical procedure. People in this age group who have had at least two hospital stays, each lasting more than 72 hours, and have received systemic antibiotics in the past year are also eligible. 

“With the emergence of difficult-to-manage strains of C. diff, CDI has become more frequent, more severe and more difficult to treat in recent years, raising concerns about how to control it and prevent transmission,” explained Alpa Patel, MD of JCCR. “Vaccination could be an efficacious, cost-effective and important public-health measure to protect individuals from C. diff.”

In 2010, the U.S. Food and Drug Administration (FDA) granted fast-track designation to the investigational C. diff vaccine candidate being developed by Sanofi Pasteur. The fast-track program of the FDA is designed to facilitate the development and expedite the review of new investigational drugs and vaccines that are intended to treat or prevent serious or life-threatening conditions and demonstrate the potential to address unmet medical needs.

For more information about the Cdiffense Phase III trial, please contact the JCCR study coordinator at (904) 730-0166, or visit www.Cdiffense.org.


About C. diff

Clostridium difficile (C. diff) is a potentially life-threatening, spore-forming bacterium that causes intestinal disease. According to the Centers for Disease Control and Prevention (CDC), approximately 500,000 Americans are infected with C. diff,[ii] and at least 14,000 fatalities are attributed to C. diff each year.[iii] The risk of C. diff increases with age, antibiotic treatment and time spent in hospitals or nursing homes, where multiple cases can lead to outbreaks.1 A main source of C. diff is infected patients who release spores into the environment that can then infect other people. When antibiotics disrupt the gut’s normal flora and a person has ingested C. diff spores, the C. diff bacteria multiply and release potent toxins that can damage a person’s intestinal lining and cause C. diff disease.[iv]


About Alpa Patel, MD

Dr. Alpa Patel is a Board Certified physician specializing in Internal Medicine. She has been practicing with JCCR for five years. Dr. Patel earned her degree from The University of Florida College of Medicine, Gainesville and was trained at Shands Hospital Department of Internal Medicine, Jacksonville.


The clinical trial facility is located at 4085 University Blvd. S., Ste. 1; Jacksonville, FL 32216 For more information, please call (904) 730-0166 or www.jaxresearch.com



[i] Centers for Disease Control and Prevention. Frequently Asked Questions about Clostridium difficile for Healthcare Providers. Centers for Disease Control and Prevention. http://www.cdc.gov/HAI/organisms/cdiff/Cdiff_faqs_HCP.html. Last Updated March 6, 2013. Accessed May 30, 2013.


[ii] Rohlke F and Stollman N. Fecal microbiota transplantation in relapsing Clostridium difficile infection. Therap Adv Gastroenterol. 2012 November; 5(6): 403–420. http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3491681/#bibr37-1756283X12453637. Accessed May 30, 2013.


[iii] Centers for Disease Control and Prevention. Clostridium difficile Infection. Centers for Disease Control and Prevention. http://www.cdc.gov/hai/organisms/cdiff/cdiff_infect.html. Last Updated March 1, 2013. Accessed May 30, 2013.


[iv] Delmee M and Warny M. (1995). Clostridium difficile colitis: recent therapeutical and immunologicalconsiderations. Acta Gastroenterol Belg, 58 (3-4), p. 313-317.


Posted by Amy Autry Bush Thursday, January 16, 2014 1:43:00 PM Categories: Breakthroughs
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