Physicians host open forum about clinical trials

by JONATHAN ERDMAN | 11/7/08 4:09am

Physicians at Dartmouth-Hitchcock Medical Center's second annual Clinical Research Awareness Day emphasized the importance of that clinical trials have for testing new medications. The day-long event, held Thursday, aimed to educate employees and the local community about current research projects and clinical trials at the hospital.

"When we or a family member takes a medicine, it was tested on humans somewhere in the world," Sandy Soho, who co-chaired the event this year, said. "We must be extremely grateful to all the clinical research participants."

In one of two keynote speeches to an audience of approximately 100 hospital employees and community members, Ethan Dmitrovsky, a professor at Dartmouth Medical School and College President James Wright's senior advisor for science and technology, stressed the importance of clinical trials.

"Making a drug is hard and can take a long time," he said, adding that 15 years can pass between a researcher's initial experiments and approval from the Food and Drug Administration. Ultimately, this process requires over $1 billion and 700 clinical trial participants, Dmitrovsky said.

This year's event was much larger than last year's, Soho said. The hospital also decided to invite outside organizations, such as the Food and Drug Administration and the Committee for the Protection of Human Subjects, to help educate those who attended.

The CPHS distributed copies of the Research Participants' Bill of Rights, a list of federal laws that outlines how a research participant must be treated. In a clinical trial, participants must be protected from coercion and informed of all possible risks, and are allowed to withdraw from the study at any time.

Brendan Slagle, the clinical research coordinator at DHMC's Norris Cotton Cancer Center, said that whenever a research participant is admitted to the hospital because of complications, the incident is defined as a "serious adverse event." The FDA must be immediately notified and the consent form that lists side effects must be revised to include these possible problems, Slagle said.

Thirty posters also detailed research currently underway at DHMC, including projects in rehabilitation medicine and clinical pharmacology. The researchers were available for questions for an hour at the end of the day.

One research project on display compared the effectiveness of three different bronchodilators, a drug that opens the airways of those suffering from a respiratory disorder, Dean Jarvis, one of the researchers, said. All three medications were found to be equally effective in treating this disorder, Jarvis explained.

This type of study, which was conducted at the Children's Hospital at Dartmouth, has never been conducted before and will be published in Pediatric Critical Care Medicine Magazine next month, according to Jarvis.

Another project is examining new methods of administering drugs. There are certain drugs that can only dissolve in fat, such as some medicines that treat lung and breast cancer, but injecting patients with fat is detrimental, Lionel Lewis, a researcher on the project, said. However, Acusphere, Inc., a pharmaceutical company co-founded by Sherri Oberg '82 Tu '86, developed a technique in which the drug is attached to a microscopic particle of sugar and inserted into an artery. Once in the bloodstream, the sugar dissolves and the drug is released into the body, Lewis explained.

The event was organized by the Clinical Trials Office, which oversees all research projects at DHMC by providing education, tracking participation and ensuring federal guidelines are met by researchers, according to Soho.