e so generous that money alone becomes the <strong>in</strong>centive to participate. If all thatpasses muster, the trial is granted approval.Dur<strong>in</strong>g the trial, those runn<strong>in</strong>g 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 — dur<strong>in</strong>g the trial must beimmediately reported to the IRB, which exam<strong>in</strong>es the event to determ<strong>in</strong>e if itis isolated, part of a pattern or has noth<strong>in</strong>g to do with the trial.“We look for anyth<strong>in</strong>g unexpected,” Dr. Williams says.Some side effects can be predicted, and participants are always warned <strong>in</strong>advance. But if the side effects occur more often than predicted, the board will<strong>in</strong>vestigate.Board auditors regularly <strong>in</strong>spect the trials, and if corporate sponsors are<strong>in</strong>volved, they may also send <strong>in</strong> 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,advis<strong>in</strong>g them on possible issues of civil and crim<strong>in</strong>al liability and keep<strong>in</strong>g theirmedical data safe and confidential.“We talk a lot about physical safety, but there are all k<strong>in</strong>ds of risks that wehave to take <strong>in</strong>to account,” says review board manager Betsy Conner.There is constant monitor<strong>in</strong>g of all trials, and they can be stopped at any time.Beneath the layers of protocol and the mounta<strong>in</strong>s of data, cl<strong>in</strong>ical 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 <strong>in</strong> a number of cl<strong>in</strong>ical trials atEVMS, <strong>in</strong>volv<strong>in</strong>g women’s health and others, between 2001 and 2008.At first, her motivation was purely selfish - free medical care.“The ultimate goal of cl<strong>in</strong>ical trials is totranslate basic research <strong>in</strong>to new productsand practices <strong>in</strong> order to improve medicalcare. It benefits society and advancesmedical knowledge and understand<strong>in</strong>g.William Wasilenko, PhDAssociate Dean for Research“18Fall 2009 www.eVMS.EDU cl<strong>in</strong>ical trials
“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