If more physicians worked to increase their patients’ awareness about the value of clinical trials, participation might increase and help advance treatments for cancer, according to new research on patient attitudes about such studies, published in the August Journal of Clinical Oncology (Vol. 19, No. 15: 3554-3561).

Clinical trials are considered the best way to determine whether promising treatments work as well or better, or in some cases less well, than more established ones. In such a trial, or study, some patients are randomly (by chance) allocated to receive the standard treatment, while others receive new therapies. Sometimes neither the patient nor the physician will know which treatment the patient receives so that the two therapies can be compared objectively.

Hundreds of trials are launched annually by medical groups, universities and private firms, yet only a small percentage of people who are eligible enroll in clinical trials, observes Ralph Vogler, MD, the American Cancer Society ’s (ACS) scientific program director, who deems this situation “a big problem.”

“It takes longer to get answers than it should, and some studies have to be dropped because they never reach their goal of number of people enrolled,” Vogler tells ACS News Today.

In this new study, researchers at the Hamilton Regional Cancer Center in Ontario, Canada, the University of Sydney, Sydney University and other colleagues in Australia, surveyed 545 patients about whether they would join a clinical trial if they had breast cancer. The women were on average aged 49 and were attending a breast clinic in Sydney.

Although 86% of the women said they thought patients should be offered the opportunity to participate in a trial, only 33% said they themselves would do so. The rate was lower among women who actually had cancer at that time compared to women who were attending the clinic for mammograms or other appointments.

The reasons women gave for wanting to join included the “possibility of a greater chance of cure, furthering medical research, and benefiting others.” Fear that the side effects and treatment might be worse than standard treatment, and “the doctor may not know as much about the treatment,” were reasons women cited for declining to join a trial. Women also were asked questions to assess their level of understanding about trials.

“The point that comes out of this research which is different than previous research, and also encouraging, is that women who were more likely to consider trial participation appeared to have a better understanding of the issues about trial participation and were more active participants in decision-making,” says Peter Ellis, PhD, with Hamilton Regional Cancer Center. “This at least suggests that people do not passively acquiesce to participate in a clinical trial.

“The message from this study is that people in the community may have preconceived ideas about randomized clinical trials that are based in misunderstandings about clinical trials. They should keep an open mind about clinical trials and talk to their physician to see if there are any trials that would be appropriate to their situation,” Ellis adds.

“The study does suggest that there is a need to raise awareness in the community of the need for and manner in which clinical trials are conducted,” Ellis says.

“The strongest arguments for participating in a well-conducted, randomized clinical trial are that the patient will receive the current best standard treatment or something considered to be as good or potentially better,” Ellis says. “Therefore, they will receive treatment effective for their [disease], and at the same time, they will contribute to future knowledge. In addition, they will be monitored closely during the course of the trial.”

Drawbacks of participation, he says, are “neither the physician nor the patient will select the treatment, there may be additional or unknown side effects from the experimental treatment arm, and there may be more frequent visits and tests.”

Vogler tells ACS News Today when he talks to patients about such matters, he tries to address any concerns and let them know they are not getting substandard care. He also tries to make the purpose of the study more clear.

“I think the professional field has to better educate people,” Vogler says. “You have to point out, first of all, that the study is not intended to do any harm, and it may be of benefit because the treatment they receive might be a little better than what is usually being offered. The purpose is to improve treatments. I also emphasize that they have the right to withdraw from a trial at any time and it will not [negatively] affect they way they are treated.”