Symposium examines best practices in trials process

March 6 , 2006
Symposium examines best practices in clinical trials process

BY Alfred Charles

Nearly 100 people gathered this week for a daylong seminar to explore ways to strengthen the process used by Emory researchers to conduct medical research.

The symposium, “Ethics in Action: Building Trust and Effectiveness in the Clinical Trial Process—Are We Doing Our Best?” was held March 1 at Cox Hall. The event was sponsored by the School of Medicine Clinical Trials Office and the Emory Center for Ethics Training, and featured a list of speakers, all of whom lectured on ways to improve the clinical trial experience. Conference attendees also broke into smaller groups to complete a variety of case study exercises to explore how they would handle a series of hypothetical situations.

Organizers worked for a year to create the conference. The officials decided to hold the symposium partly out of a fear that some groups, including minorities, the poor and disabled, were not getting adequate opportunities to take part in Emory’s clinical trials, which allow participants to sample new drugs and medical devices or try new treatment methods.

“We didn’t feel like we were reaching all the people that we could have,” said Carol Means, an event organizer in the clinical trials office. “We need to rethink how we’re presenting studies to the different communities.”

The main topics of the program included lectures by speakers on how to avoid coercion when searching for research participants, how to better recruit minorities, how to use the news media to publicize the research process and how to improve the form given to people who agree to be a part of the trials.

Carlos del Rio, professor of medicine for infectious diseases who also works with patients at Grady Hospital, led the session on how to boost the number of minorities who participate in clinical trials.

“Recruitment is not just putting fliers out there,” he said. “There is a whole science behind it.”

In his position at Grady’s Hope Clinic, del Rio works with patients who are suffering from infectious diseases. He said workers at the clinic formed a promotional advisory committee to craft ways to reach out to the sick, many of whom are minority. Some of the patients are suspicious of efforts to get them to participate in clinical trials.

The distrust spurred a proactive plan to engage the patients, including outreach efforts that linked to third-party groups, the Internet and special events, del Rio said.

Ezekiel Emanuel, department chair of clinical bioethics at the National Institutes of Health, led a rousing discussion on how researchers can avoid coercion or exploiting research participants.

Emanuel said the ultimate solution was for researchers to ensure that they were focusing on the details of the study first, specifically the risks and benefits, before discussing what the research program had to offer.
Randy Martin, professor of medicine who also works as a health reporter for WSB-TV/Channel 2, led the session on how researchers can better use the news media when promoting their cause.

“The media can be your best friend, but the media can also be your worst enemy,” said Martin, who worked for the television station since 1994. He suggested that researchers find real people to make their case for the necessity of the research. For example, he said instead of having a doctor talk about the need for a particular treatment, have a patient talk about their experience.

“Using the media can be advantageous if you know how to go at it in the right direction,” Martin said. “The media can be a very, very powerful vehicle to tell our story, which I don’t think has been properly told.”
Part of the event focused on how researchers can make the consent form given to potential research participants more user-friendly.

“The language has always been very technical,” Means said.

James Keller, chairman of the Emory Institutional Review Board, gave a detailed description of what tips to follow when devising the consent form, including keeping terms simple enough for an eighth grade student to understand.

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