in Hampton Roads in Hampton Roads - Eastern Virginia Medical ...
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e so generous that money alone becomes the incentive to participate. If all thatpasses muster, the trial is granted approval.During the trial, those running it must submit a renewal application at leastonce a year, although it may be required more frequently, Dr. Williams says.Any adverse event — a negative side effect — during the trial must beimmediately reported to the IRB, which examines the event to determine if itis isolated, part of a pattern or has nothing to do with the trial.“We look for anything unexpected,” Dr. Williams says.Some side effects can be predicted, and participants are always warned inadvance. But if the side effects occur more often than predicted, the board willinvestigate.Board auditors regularly inspect the trials, and if corporate sponsors areinvolved, they may also send in people to monitor the trial.To ensure that participants always know at least one person to contact withconcerns, Dr. Williams’ name and phone number are listed on all consent formsso participants can contact him directly, though that rarely happens.The board protects not just participants’ physical safety but legal rights as well,advising them on possible issues of civil and criminal liability and keeping theirmedical data safe and confidential.“We talk a lot about physical safety, but there are all kinds of risks that wehave to take into account,” says review board manager Betsy Conner.There is constant monitoring of all trials, and they can be stopped at any time.Beneath the layers of protocol and the mountains of data, clinical trialsrely on the altruism of those who take part. Gillian Durham heardabout the trials through a friend. Ms. Durham teaches English as asecond language at TCC. She has participated in a number of clinical trials atEVMS, involving women’s health and others, between 2001 and 2008.At first, her motivation was purely selfish - free medical care.“The ultimate goal of clinical trials is totranslate basic research into new productsand practices in order to improve medicalcare. It benefits society and advancesmedical knowledge and understanding.William Wasilenko, PhDAssociate Dean for Research“18Fall 2009 www.eVMS.EDU clinical trials
“I have dual citizenship in the U.S. and Australia, and over there I had freemedical care,” she says. “I was uninsured when I moved here, and I had somehealth concerns.”During her first trial for a contraceptive, she received free care for women‘sissues.“You get a complete medical workup,” she says. “In fact, it was the best healthcare I ever got.”The trials can be, well, a trial. During the tests she had to keep meticulousrecords, and for one even had a biopsy.“You have to take it seriously,” she says.She was compensated for her time (payment varies depending on howinvolved the trial is). The more she took part the more she discovered how thetrials would help other people down the road.“I was told some of the products we were testing could be used to help peoplein Africa and other continents avoid sexually transmitted diseases like AIDS,”she says. “That really made it seem worthwhile and valuable.”Over time the recruitment process has changed. When the EVMS ClinicalResearch Center began, Dr. Archer would recruit women from his own practicewho fit the profile. Now, researchers advertise through TV, radio and fliers tolook for a target population. Some centers have a full-time recruiter. Dependingon the trial, screeners can talk to a few people or 100 to get one participant forthe trial.Dr. Archer himself has taken part in a doctor’s health study since 1984.“It’s something I felt like I should do,” he says.EVMS has been a leader in a wide range of medical trials, says WilliamWasilenko, PhD, associate dean for research.“The school is very involved in advancing basic research, fromcontraception and women’s and infant health and fertility to infectious diseasesand diabetes,” he says.Examples include the contraceptive Seasonal, a new software for ultrasoundmachines and a method of detecting blood proteins as a way to screen for certaintypes of cancer.The school’s research benefits students and the community, Dr. Wasilenkosays.“For students it’s an opportunity for scientific inquiry and keeping themomentum going for future discoveries,” he says. “The school brings tothe community a unique opportunity to participate in clinical trials for newtherapies. People can benefit from cutting-edge research and treatments, eitherdirectly or by contributing to necessary data.”It can be an exciting feeling for everyone involved, he says.“The ultimate goal of clinical trials is to translate basic research into newproducts and practices in order to improve medical care,” Dr. Wasilenko says.“It benefits society and advances medical knowledge and understanding.”Nurse Candice Williams gives Patty Collins the second of two vaccinationsfor H1N1 during a test of the vaccine at the EVMS Glennan Center inAugust. Testing at the Glennan Center and at other sites around thecountry demonstrated that one injection was sufficient, helping to makethe most of limited amounts of the vaccine early in the flu season.clinical trials www.eVMS.EDU fall 2009 19
- 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 16 and 17: But what exactly are clinical trial
- 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
“I have dual citizenship <strong>in</strong> the U.S. and Australia, and over there I had freemedical care,” she says. “I was un<strong>in</strong>sured when I moved here, and I had somehealth concerns.”Dur<strong>in</strong>g her first trial for a contraceptive, she received free care for women‘sissues.“You get a complete medical workup,” she says. “In fact, it was the best healthcare I ever got.”The trials can be, well, a trial. Dur<strong>in</strong>g the tests she had to keep meticulousrecords, and for one even had a biopsy.“You have to take it seriously,” she says.She was compensated for her time (payment varies depend<strong>in</strong>g on how<strong>in</strong>volved the trial is). The more she took part the more she discovered how thetrials would help other people down the road.“I was told some of the products we were test<strong>in</strong>g could be used to help people<strong>in</strong> Africa and other cont<strong>in</strong>ents avoid sexually transmitted diseases like AIDS,”she says. “That really made it seem worthwhile and valuable.”Over time the recruitment process has changed. When the EVMS Cl<strong>in</strong>icalResearch Center began, Dr. Archer would recruit women from his own practicewho fit the profile. Now, researchers advertise through TV, radio and fliers tolook for a target population. Some centers have a full-time recruiter. Depend<strong>in</strong>gon the trial, screeners can talk to a few people or 100 to get one participant forthe trial.Dr. Archer himself has taken part <strong>in</strong> a doctor’s health study s<strong>in</strong>ce 1984.“It’s someth<strong>in</strong>g I felt like I should do,” he says.EVMS has been a leader <strong>in</strong> a wide range of medical trials, says WilliamWasilenko, PhD, associate dean for research.“The school is very <strong>in</strong>volved <strong>in</strong> advanc<strong>in</strong>g basic research, fromcontraception and women’s and <strong>in</strong>fant health and fertility to <strong>in</strong>fectious diseasesand diabetes,” he says.Examples <strong>in</strong>clude the contraceptive Seasonal, a new software for ultrasoundmach<strong>in</strong>es and a method of detect<strong>in</strong>g blood prote<strong>in</strong>s as a way to screen for certa<strong>in</strong>types of cancer.The school’s research benefits students and the community, Dr. Wasilenkosays.“For students it’s an opportunity for scientific <strong>in</strong>quiry and keep<strong>in</strong>g themomentum go<strong>in</strong>g for future discoveries,” he says. “The school br<strong>in</strong>gs tothe community a unique opportunity to participate <strong>in</strong> cl<strong>in</strong>ical trials for newtherapies. People can benefit from cutt<strong>in</strong>g-edge research and treatments, eitherdirectly or by contribut<strong>in</strong>g to necessary data.”It can be an excit<strong>in</strong>g feel<strong>in</strong>g for everyone <strong>in</strong>volved, he says.“The ultimate goal of cl<strong>in</strong>ical trials is to translate basic research <strong>in</strong>to newproducts and practices <strong>in</strong> order to improve medical care,” Dr. Wasilenko says.“It benefits society and advances medical knowledge and understand<strong>in</strong>g.”Nurse Candice Williams gives Patty Coll<strong>in</strong>s the second of two vacc<strong>in</strong>ationsfor H1N1 dur<strong>in</strong>g a test of the vacc<strong>in</strong>e at the EVMS Glennan Center <strong>in</strong>August. Test<strong>in</strong>g at the Glennan Center and at other sites around thecountry demonstrated that one <strong>in</strong>jection was sufficient, help<strong>in</strong>g to makethe most of limited amounts of the vacc<strong>in</strong>e early <strong>in</strong> the flu season.cl<strong>in</strong>ical trials www.eVMS.EDU fall 2009 19
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