Risks & Benefits of Clinical Trials Often Misunderstood

Clinical Trials' Risks and Benefits Often Misunderstood

Clinical trials are usually designed to benefit future patients. People who join clinical trials help doctors learn which treatments work best.

Yet, some patients and doctors don't understand that participants don't always benefit, according to a new study on informed consent in The Lancet (Vol. 358, p. 1772-1777).

Informed consent is permission from patients who have been told about their experimental treatment and understand what might or might not happen. Earlier studies have raised questions about how well informed patients are. Some experts questioned whether they really understood enough to make a decision.

Study Looks at Patients' and Doctors' Views

Researchers in Boston developed a questionnaire to see how well newly enrolled study participants understood their trials. The researchers also wanted to see how they could help the patients understand better.

The survey was created by Steven Joffe, MD, MPH, of the Dana-Faber Cancer Institute and at Boston Children’s Hospital, and his colleagues from two other hospitals.

"While many clinical trial participants will benefit directly from participation, this is not the trials' primary purpose," Joffe said. "Cancer patients today do, however, benefit from what has been learned in previous trials. By participating in trials, they can help to ensure that treatment continues to improve for future generations of patients.”

Joffee and his colleagues surveyed 207 patients who had recently agreed to participate in clinical trials. They also looked at 240 physicians who took part in getting the patients to join the studies. The patients and physicians all had used consent forms that had been developed by the National Cancer Institute. While 90% of patients said they were “satisfied” with how the informed consent process was handled and that they felt well informed, they not clear on other significant points. And their physicians were uncertain as well, said the researchers.

Joffe reports that doctors seemed to be under a “therapeutic misconception." This means they believed that there might be more benefit to patients than there really could be from the trial.

Expert Suggests Looking at All the Possible Avenues

But, he said, “There were a lot of positive findings in our study, including the high levels of satisfaction among participants as well as the fact that almost nobody felt pressured” to join a trial.

He said that two important messages came from the findings regarding patients considering joining in a trial.

“First, when considering a clinical trial, make sure you know what the main alternatives are,” Joffe said. “Then, make sure you understand how being in the clinical trial differs from those alternatives. Make sure you understand how the risks are different, how the benefits are different, how the procedures are different.”

Joffe said that this way of choosing whether to join “is important because often the treatment you will receive on a clinical trial has much in common with the standard therapy. By focusing on the differences, you will be able to make an informed choice between your options.”

Joffe said that it shouldn’t be assumed patients wouldn't want to participate in trials if they realize they might not gain from the experience. In fact, this concept might appeal to their sense of altruism. This might encourage greater involvement, he said.

American Cancer Society article, 1/02

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