Should staff education should be a major focus?

Cancer doctor describes teaching session

All clinical trial sites, including small sites in physicians’ clinics, need to provide formal education for clinical trial professionals, who are the front-line ambassadors to the world of human subjects research, an expert says.

"It’s the obligation of the clinical trial site to educate them," says James Atkins, MD, a principal investigator with the Southeast Cancer Control Consortium, which has a central office in Winston-Salem, NC.

Clinical research professionals also have an obligation to educate themselves, using all of their resources to expand their knowledge about why clinical trials are important, Atkins says.

Atkins is in private practice at the Southeastern Medical Oncology Center in Goldsboro, NC. He received the National Cancer Institute’s Harry Hynes Award for community clinical oncology program research on March 9, 2006, at the Community Clinical Oncology Program and Research Base Meeting in Washington, DC.

There are tangible benefits to educating clinical trial staff, and it can take place in a three-hour session, Atkins notes.

For example, Atkins recently spoke about clinical trial research and education to a small group that included a nurse who assisted a radiation oncologist.

The nurse had been unable to enroll patients in a clinical trial, but she didn’t realize the problem was her own bias. Atkins says.

The woman thought of clinical trial participants as guinea pigs, so while she would talk with patients about the trial, they were turned off by the messenger, Atkins says.

"She’d been working at the radiation oncologist’s office for several months, and she had not accrued one patient to the trial, he says.

"Whatever biases she had from her previous existence were interfering with her ability to get the clinical trial information across to the patients," Atkins explains.

After attending the educational session, the same nurse returned to work and was able to enroll several patients into the trial, " Atkins says.

Atkins offers these tips on educating clinical trial staff:

Explain why we do clinical trials.

Explain to clinical trial staff why researchers conduct clinical trials, Atkins says.

"What is the value? What’s in it for me, for the patient, for the doctor?" Atkins says. "We try to get people to understand the significance of what’s going on and why it’s important."

Clinical trial staff should be encouraged to sit with physician investigators to listen to how they describe a study to patients, Atkins says. "If they don’t know what the doctor is telling patients, they don’t know what to reinforce or to explain or to put into their own words," he explains. "The clinical trial staff’s job also is to educate patients."

Empower the research team.

Research is a team effort, so clinical trial professionals need to know how to work with the laboratory, the radiation therapy department, the front office billing, chemotherapy, and all of the different departments or staff who contribute to a clinical trial, Atkins says.

In Atkins’ private practice there are five full-time data managers, who are clinical research professionals, Atkins says. "We have 160 people enrolled on clinical trials each year and 1,000 in follow-up in a small town of 32,000. We’re very involved and strongly believe in clinical trials, so it makes it easy when everyone is reading from the same page of the hymnal."

Talk about the finances.

"We also talk about finances and how a research site can break even," Atkins says. "You’re not going to make any money doing clinical trial studies, but we don’t want to lose money." So explain to clinical trial staff how they can contribute to a goal of breaking even, he suggests.

Discuss research and ethics.

Any educational session with clinical trial staff needs to include a discussion of research ethics and the history of ethical problems. The staff should understand that ethical lapses can lead to fraud and misconduct, as well as to greater risk and harm to study volunteers, Atkins says. "People can make mistakes, and it is important we try to be ethical and talk about those [past] problems."

Likewise, trial education should cover the IRB process and the IRB’s role in research. For most cancer research studies, the IRB’s primary role is to make certain the study is appropriate for the local community in which participants live, and the IRB will be less involved in the scientific value of the clinical trial, because that has already been thoroughly reviewed by national cancer groups and centers, Atkins says.

Encourage a new way to view the disease under study.

For cancer research and treatment, Atkins encourages staff and patients to think of it from a different perspective. "I try to make people think outside the box a little bit," Atkins says. "One other thing we do with all of our patients is to audiotape the patient’s very first visit. We’ve been doing that for over 15 years because patients won’t remember what you say."

This same technique could be used during the informed consent process of a clinical trial, but Atkins’ data managers typically do not tape these sessions, he notes.

At the first visit with a cancer patient, Atkins will discuss the type of cancer they have, as well as give them information about treatment. The session may last more than an hour, and it would be difficult for a patient and his or her spouse to recall many details from the session without the audiotape as a reminder.

"I taped a session for a pathologist patient, who had lung cancer, and six months later his wife called me to say, Do you realize you said such and such on the tape?’" Atkins recalls. "She said, I’ve listened to the tape four times, and that was the first time I heard you say it.’"

This example shows how important the tape could be even to patients who are very knowledgeable about medicine, Atkins notes.

"One colleague who has breast cancer and is active in patient advocacy says she remembers her oncologist’s mouth moving up and down, but not any words coming out," Atkins says. "The reason I started audiotaping is because some patients would bring in an audiotape, and I always felt like there was a lawyer outside the door. Then I decided to give an audiotape to patients as a gift to them."

Although some lawyers will discourage doctors from audiotaping sessions, Atkins says that the discussions he has with patients are so routine that the audiotape will only help the patients understand better and will prevent communication problems down the road. "I can justify the words I use, but I can’t justify the words they thought they heard."