Written by Charles F. Lovell, Jr., MD, FACP, Medical Director, Sentara Medical Group Clinical Research.
Sentara Medical Group Clinical Research is actively engaged in medical and surgical innovation and discovery. At our research sites, we are evaluating new drugs and devices and improving existing ones.
Do you know what are the most important characteristics of a drug or medical device? They are safety and efficacy.
First do no harm
The Hippocratic Oath taken by all our physician/researchers admonishes us Primum non Nocere – Latin for “first do no harm”. Sentara Medical Group Clinical Research collaborates with many other research sites nationally and world-wide to assure that drugs and devices are safe. Many therapeutic claims are made for substances popularized by broadcast and print media, and often endorsed by celebrity spokespersons. An important distinction exists between such agents and licensed pharmaceuticals. By not seeking Food and Drug Administration (FDA) licensure, and by often obtaining classification as foods, rather than as drugs, these substances escape formal evaluation under FDA scrutiny. Caveat Emptor – Latin for let the buyer beware – is the prudent public posture relative to these substances.
Modern clinical trial designs assess safety, and endeavor to demonstrate with statistical rigor that a drug or device in development provides the benefits it is intended to provide. The drug or device must confer one or more benefits than would occur by chance or serendipity. The research Sentara Medical Group engages in is characteristically, randomized, double-blinded, controlled, prospective, and often intention-to-treat design. Clinical endpoints for the studies are chosen in advance, as well as the statistical methodologies to be utilized in assessing efficacy. These design features minimize bias, and assure safety and efficacy.
Our areas of focus
The Sentara Medical Group Clinical Research team of study coordinators and investigators conducts studies in diabetes, hypertension,vascular medicine and surgery, asthma, coronary heart disease, irritable bowel disease, neurology, cancer, bariatric medicine, rheumatology, and other clinical areas.
Sentara Medical Group Clinical Research spans many medical and surgical specialties and is committed to Shaping Tomorrow’s Healthcare through Innovation and Discovery.
Stay tuned because next month, I will discuss the importance of the research volunteer.
Take a virtual tour of the Sentara Medical Group Clinical Research lab.