Once mostly interested in young, healthy males, clinical researchers here say seniors now play an integral role in testing new drugs and medical devices.


Spokane has a large, fairly nontransient population of older adults, they say, allowing the research community here to take on studies that require participants with diverse age ranges.


Spokane is kind of this well-kept secret in that were often in the top 10 nationwide for enrolling patients, says Marian Fisher, research director for Empire Health Services. If you look at every site in most studies, we are in the top 10 for quality of data and quantity of people involved.


Both Fisher and Dennis Clifton, director of Sacred Heart Medical Centers clinical research center, say clinical research typically isnt geared toward seniors exclusively, but nonetheless often is focused on diseases and conditions that mostly affect seniors.


Clifton says that seniors participation can provide a study with more diversity, giving researchers a better chance of identifying serious adverse effects. Identifying those effects early, he says, can help to decrease the number of potentially unsafe drugs that make it to the market.


In early drug trials, he says, seniors involvement also can help determine proper dosing.


Marjorie Lefevre, a senior from Ritzville, Wash., is participating in one study here, and says, I thought that if it could help somebody, itd be worth it.


She says the free medications provided through the study also make it attractive.


Clifton says that finding participants for a study can be challenging, but seniors often are up to the task.


They tend to be able to look at it more from a societal perspective, he says. They can say, This might not benefit me, but it might benefit someone I know.


The inclusion of seniors in studies has evolved over the last 20 years or so due to a handful of factors, Clifton says.


In the late 1980s, he says, the U.S. Food and Drug Administration determined that elderly people werent represented well in most studies, and it developed guidelines so that more seniors would be included.


Investigators previously had conducted early-stage trials mostly on young, healthy men, because that demographic was less likely to have health conditions that could cloud a studys results, Clifton says. Healthy men still are used frequently in early trials, but more seniors now are brought into the mix as well, he says.


Federal legislation passed in the late 1990s that allows Medicare to pay for certain investigational devices, as well as the hospitalization involved with studies of such devices, has brought more seniors into research studies. Previously, Clifton says, Medicare wouldnt pay for experimental devices and could deny payment of an entire hospitalization associated with an experimental procedure.


That change, however, could present its own dilemma, Clifton says. With Medicare paying for some test procedures, its possible that certain types of research will end up with too heavy of a concentration of elderly patients, he says.


It sets up a unique problemthe opposite problem of when we had all younger people, Clifton says. The potential problem is that the predominance of research will be in the Medicare population.


Study phases


Clinical trials must be approved by a local review board before they can proceed. Here, the Institutional Review Board-Spokane reviews all studies proposed for Spokane-area hospitals.


Jan Eldredge, coordinator of that board, says it reviews about eight new studies a month, and at least half of those include adults with a broad range of ages.


Clifton and Fisher say clinical trials for experimental drugs fall into three phases.


Phase one trials typically involve a small number of participants and are designed to determine whether a drug has any adverse effects. Phase two trials often involve hundreds of people here, including some who are afflicted with the condition a drug is expected to address and some without the condition, and begin to look at the effectiveness of the drug. The third phase, also called a pivotal trial, typically involves thousands of patients at multiple test sites and compares a drugs effects to that of other forms of treatment and of a placebo.


At any given time, both Clifton and Fisher say, hundreds of clinical trials are under way in the Spokane medical community, at hospitals and at physicians offices. Most of them are phase three trials, though some phase one and two testing is being conducted here.


Clinical trials involving medical devices dont follow the same phased path, but also typically are tested in stages. Similar to drug trials, device studies conducted here typically are part of widespread testing late in the process, Clifton says.


Looking for seniors


Washington State University at Spokane currently is one of 70 sites for a National Institutes of Health study mostly involving seniors. The study is looking at the correlation between diabetes and cardiovascular disease and is called the Action to Control Cardiovascular Risk and Diabetes, or ACCORD, trial.


Debbie Weeks, WSU-Spokane research associate and lead coordinator here for the trial, says that unlike studies that look for young candidates, the researchers in the study are focusing almost exclusively on seniors who have diabetes and signs of cardiovascular disease. The study does accept young participants, but they must have diabetes and already have experienced a heart attack or stroke.


Weeks says the study accepts roughly one out of every four potential participants during an initial screening, and most who make it through that screening are allowed to enter the study.


WSU-Spokane has enrolled 76 participants so far, and hopes to enroll a total of 200 by June 2005. Weeks says nearly all who are screened and found eligible agree to join the study.


Clifton cautions that generally, researchers have to take extra steps in some instances to be certain that seniors are able to give informed consent to participate in a study. He says researchers have to make sure they dont enroll somebody who doesnt understand the benefits and risks of the research.


Fisher says researchers at Empire Health try not to treat seniors differently than other study participants, but many of the overall policies theyve developed regarding research are a result of working with seniors.


For example, she says, Empire Health educates all participants at different stages during a study and asks them to sign informed-consent forms at those times. Also, participants are called the day before an appointment as a reminder.