in Hampton Roads in Hampton Roads - Eastern Virginia Medical ...
in Hampton Roads in Hampton Roads - Eastern Virginia Medical ... in Hampton Roads in Hampton Roads - Eastern Virginia Medical ...
But what exactly are clinical trials?Most people know trials are tests on human subjects designed to seewhether a drug or treatment works. It’s not as well known just whatgoes into producing clinical trials, how they work and how important they arein medical research.David Archer, MD, EVMS professor of obstetrics and gynecology anddirector of the school’s Clinical Research Center, has overseen some 230 clinicaltrials involving more than 10,000 participants since 1987.“We’re the guys who get to see the previews of coming attractions,” Dr.Archer says. “And we see it with all the warts — if there are problems weknow about it.”At any given time, there are more than 1,000 trials under way at the downtownNorfolk campus. Clinical trials are an indispensable step in the development ofnew treatments and therapies, a key testing ground for medical breakthroughs.It’s because of such research that modern medicine can manage diabetes andfight cancer — or even soothe a pounding headache.“The average American, when they have a problem, goes to a pharmacyand picks up something on the shelf that claims to help with their symptom —At any given time, there are morethan 1,000 trials under way at thedowntown Norfolk campus.The EVMS volunteerreview boardsinclude physiciansand scientists aswell as lay peoplefrom within andoutside EVMS.16Fall 2009 www.eVMS.EDU clinical trials
New Productor TreatmentOnce a product has been developed inthe laboratory and tested successfully onanimals, then clinical trials on humanscan begin.Submitted forreviewIRB ReviewEnsuring safetyand effectivenessheadache, warts, what have you,” Dr. Archer says. “Clinical trials are how weprove that those products are effective.”In other words, to see if they do what they say they do.The products or treatments being tested may come from an EVMS researcher,a pharmaceutical company or other sources. Once a product has been developedin the laboratory and tested successfully on animals, then clinical trials onhumans can begin.“It’s a long process,” says Aaron I. Vinik, MD, scientific director at the EVMSStrelitz Diabetes Center, another physician with decades of research experience.“There is a need for vigilance and attention to make sure the drugs are safeand effective.”Research on humans takes place in sequential phases. In Phase I trials,researchers test the drug or treatment on a small number of people —sometimes as few as a dozen — to gauge safety and effectiveness andlook for side effects. In Phase II and Phase III, the test groups are progressivelylarger. Phase III trials may also compare the product to others already on themarket as a way of ensuring the new concept improves upon what’s alreadyavailable. Phase IV trials may take place after the product is on the market, togather more information and ensure its long-term safety.Fewer and fewer drugs make it to the later stages of testing, as ineffective orunsafe products are weeded out. It is a rigorous, time-consuming process, butresearchers say it’s all to ensure only the best treatments reach the market. Thetremendous rate of attrition means as few as one in 20 new compounds makesit to the final phase of testing.Every step of the process is overseen by the Food and Drug Administration,the researchers and the EVMS Office of Research Subjects Protection. TheEVMS office oversees two Institutional Review Boards (IRB), which are chargedwith protecting the safety and legal rights of participants in clinical trials.The volunteer review boards are made up of physicians from a variety ofEVMS departments as well as scientists, administrators and people outside ofthe school.Before any clinical trial can begin, investigators must apply to the reviewboard.“We look at what are the risks versus the benefits to society,” says Robert F.Williams, PhD, associate dean for research subjects protection. “The benefitsmust outweigh the risks.”Before the IRB approves a trial, its members look into everything from thetrial’s procedures to the recruitment process to compensation, which must notPhase I TrialsSmall control grouptestingPhase II TrialsTest group expandsPhase III TrialsTest group expandsagain and includescomparisons toexisting productsPhase IV TrialsMarket placementfollow-upclinical trials www.eVMS.EDU fall 2009 17
- Page 7: Scientists awarded nearly half a mi
- Page 10 and 11: First-year medical students Rachel
- Page 12 and 13: Name change reflectsart therapist
- Page 14 and 15: Clinical TrialsGillian Durham first
- Page 18 and 19: e so generous that money alone beco
- Page 20 and 21: Turning theTide onDiabetes research
- Page 22 and 23: “ Those of us who are fortunate e
- Page 24 and 25: “ They’ve beenawfully goodto me
- Page 26 and 27: Since opening in 1987, the Strelitz
- Page 28: Claudia Keenan Hough,EVMS’ first
- Page 31 and 32: She rose to marketing director for
- Page 33 and 34: alumniDan Neumann, MD, Left,Class o
- Page 35 and 36: Graduate named toleadership post at
- Page 37 and 38: philanthropyCosmopolitan Internatio
- Page 39 and 40: Faculty and staffinvest in EVMScont
But what exactly are cl<strong>in</strong>ical trials?Most people know trials are tests on human subjects designed to seewhether a drug or treatment works. It’s not as well known just whatgoes <strong>in</strong>to produc<strong>in</strong>g cl<strong>in</strong>ical trials, how they work and how important they are<strong>in</strong> medical research.David Archer, MD, EVMS professor of obstetrics and gynecology anddirector of the school’s Cl<strong>in</strong>ical Research Center, has overseen some 230 cl<strong>in</strong>icaltrials <strong>in</strong>volv<strong>in</strong>g more than 10,000 participants s<strong>in</strong>ce 1987.“We’re the guys who get to see the previews of com<strong>in</strong>g attractions,” Dr.Archer says. “And we see it with all the warts — if there are problems weknow about it.”At any given time, there are more than 1,000 trials under way at the downtownNorfolk campus. Cl<strong>in</strong>ical trials are an <strong>in</strong>dispensable step <strong>in</strong> the development ofnew treatments and therapies, a key test<strong>in</strong>g ground for medical breakthroughs.It’s because of such research that modern medic<strong>in</strong>e can manage diabetes andfight cancer — or even soothe a pound<strong>in</strong>g headache.“The average American, when they have a problem, goes to a pharmacyand picks up someth<strong>in</strong>g on the shelf that claims to help with their symptom —At any given time, there are morethan 1,000 trials under way at thedowntown Norfolk campus.The EVMS volunteerreview boards<strong>in</strong>clude physiciansand scientists aswell as lay peoplefrom with<strong>in</strong> andoutside EVMS.16Fall 2009 www.eVMS.EDU cl<strong>in</strong>ical trials
Change language