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Clinical trials might offer help

Trial volunteers help with tests, get free care

Trial volunteers help with tests, get free care

January 28, 2008|By JULIE E. GREENE

Got a medical problem that won't go away despite everything you try?

Perhaps there's a clinical trial that might help.

Clinical trials are the required, final step in the process of getting new drugs or medical devices approved by the Food and Drug Administration, according to Tom F. Pianta, director of health management and clinical research for Washington County Hospital. Clinical trials assess the efficacy, or effectiveness, of a proposed medical treatment.

Clinical trials take different forms, according to local medical officials and the FDA's Web site. A trial might compare the effectiveness of a new drug to a placebo; or it might compare multiple drugs to see which is most effective against a certain medical condition; or it might test an drug approved by the FDA for Disease A as a treatment for Disease B.

For participating patients, clinical trials are a way to find a possible solution to a medical problem plus get free medical care related to the study, Pianta said.

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The Center for Clinical Research at Washington County Hospital is involved in 30 active clinical trials - some already under way in which medical officials are following patients' progress, and some trials that are still accepting enrollees.

How a trial works

To get approval to begin a clinical trial for a new drug, FDA spokesman Christopher DiFrancesco said, preliminary evidence must be presented that the drug is likely to be safe for people. In most cases, that evidence includes testing on two other animal species or experience with the drug in another country.

Volunteers often have coincerns about participating in a trial. While there have been instances of clinical trial participants dying, DiFrancesco said, the death might not have been related to the trial and might have occurred even if that person wasn't in the clinical trial. Rarely, a participant's death is related to side effects from the trial.

Pianta said another issue that causes some clinical trial participants to be nervous are trials that involve a placebo. Everyone wants the drug that is being tested, rather than the placebo, even though medical officials don't know if the drug works until the study is done, Pianta said.

A benefit some clinical trials offer is allowing participants to take the drug being tested once their trial period is done, said Angela Angstadt, clinical research coordinator for several trials offered through the clinical research center. This is called an open-label period or extension. Trial participants are allowed to take the actual drug, whether they were getting the drug or a placebo during the trial.

Depending on when and whether the FDA approves the drug, there might be a period of time when those participants do not have access to the drug, Angstadt said.

Local cancer research

Last fall, the Center for Clinical Research became an affiliated member of Cancer & Leukemia Group B Research Cooperative through the University of Maryland Greenbaum Cancer Center in Baltimore, Pianta said. This gives five of the hospital's doctors access to National Cancer Institute-sponsored clinical trials. So local residents who are eligible to participate in the NCI-sponsored clinical trials in which those doctors are involved can do so without traveling to big cities, Pianta said.

Participants do not have to live in Washington County. Usually participants live within a 30- to 40-minute drive, though some have driven two hours to participate, Pianta said.

With all clinical trials, enrollees are informed about the possible risks, Pianta said, and asked to sign a consent form. Some people find the consent process, which informs enrollees about the study's processes, intimidating, Pianta said. But medical officials want to answer volunteers' questions before they commit to participating in the study.

See sidebar to learn about clinical trials taking place in the Tri-State area.

To learn more ...



City Hospital

The WVUH-East Regional Cancer Program is offering some cancer clinical trials involving four chemotherapy drugs through City Hospital in Martinsburg, W.Va. Call Tammy Ware at 304-264-1287, ext. 2010.

Frederick Memorial Hospital

To find out about clinical trials available through Frederick Memorial Hospital, call Shelley Francella, coordinator of the clinical trial program, at 301-668-7043.

Summit Health

To find out about clinical trials available through Waynesboro Hospital or Chambersburg Hospital, call Summit Health's MedQuest line at 888-318-7855.

Online resources

To find clinical trials contact your local hospital or check out these Web sites:

Center for Clinical Research at Washington County Hospital - 800-411-3901 or go to www.washingtoncountyhospital.com/clinical.

CenterWatch Clinical Trials Listing Service at Centerwatch.com - can search for clinical trials by disease and state.

ClinicalTrials.gov - As of last week, this site listed more than 50,000 trials with locations in 153 countries.

Trials that are available in the Tri-State area



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