The research community is constantly seeking new treatment options for diseases and medical conditions. To make sure new medications and devices are safe and effective, they are tested by volunteers in clinical trials at facilities like Meridien Research at 5411 Beaumont Center Blvd., #760, Tampa and 120 Medical Blvd., #103, Spring Hill, FL 34609.
A clinical trial is a medical research study in which volunteers receive investigational treatments under the supervision of a board certified medical doctor. These treatments are developed by pharmaceutical and biotechnology companies who choose qualified physicians, also known as principal investigators, to conduct clinical trials to determine whether or not there are benefits to new investigational drugs.
The phases of a clinical trial
Drug and device testing begins with extensive laboratory research which can involve years of experiments in animals and human cells. If the initial laboratory research is successful, researchers send the data to the Food and Drug Administration (FDA) for approval to continue research and testing in humans.
Once approved, human testing of experimental drugs and devices can begin and is typically conducted in four phases (I, II, III and IV). Each phase is considered a separate trial and, after completion of a phase, investigators are required to submit their data for approval from the FDA before continuing to the next phase. Only a small number of people participate in phase I trials while the later phases involve a larger number of volunteers. It is estimated that 70% to 90% of drugs that reach phase III studies successfully complete this phase of testing. Once phase III testing is complete, a pharmaceutical company can request FDA approval for marketing the drug.
“The majority of the studies we see at Meridien Research are phase III and IV. This means they have been in testing for months, if not years, which should help our subjects feel more comfortable with their decision to participate in a trial,” said Cynthia Huffman, MD and Principal Investigator at Meridien Research.
Who can participate in a clinical trial?
All clinical trials have guidelines about who can participate. Before joining a trial or research study, a volunteer must qualify. The factors that let volunteers to participate in a clinical trial are called “inclusion criteria” and the factors that prevent volunteers from participating are called “exclusion criteria.” These criteria can include age, gender, the type and stage of a disease, previous treatment history and other medical conditions.
Who pays for clinical trials?
Funding for clinical research comes from the federal government such as the National Institutes of Health, the Department of Defense, the Department of Veteran’s Affairs, and private industry such as pharmaceutical and biotech companies, medical institutions, and foundations.
Benefits of participating in a clinical trial
By participating in a clinical trial, people may benefit by:
– gaining access to new treatments that are not yet available to the public
– testing drugs and procedures at no cost
– obtaining improved medical care at a leading health care facility
– playing an active role in their own health care
– improving their quality of life
– helping others by contributing to medical research
“We have seen an increase in the number of subjects who are willing to participate in a medical research study because they don’t have health insurance,” said Jennifer McCaffrey, Site Director for Meridien Research. “Some of our studies last years, so they are guaranteed treatment they otherwise couldn’t afford.”
New research studies begin almost every month. In Tampa, currently enrolling clinical research studies include those for Alzheimer’s disease, multiple sclerosis, traumatic brain injury and headaches.
For more information on Meridien Research or the studies enrolling now, call 813-563-6009 or visit www.newstudyinfo.com today!
About Meridien Research
Meridien Research has been conducting clinical research trials and studies since 2000 in the Tampa Bay area. All studies are administered by board certified doctors and highly trained medical personnel in St. Petersburg, Tampa, Bradenton, Spring Hill, Orlando and Lakeland.