In 1998, the National Surgical Adjuvant Breast and Bowel Project initiated a massive undertaking to inform more than 13,000 study participants of preliminary results from the Breast Cancer Prevention Trial. The study found that women taking tamoxifen experienced almost a 50% decrease in breast cancer risk compared with women taking a placebo.
The NSABP ended the trial early and sent results to each woman who participated in the trial. In addition, investigators made numerous phone calls to make sure each woman had received the information. "The NSABP had never taken on an effort of this magnitude," said Larry Wickerham, M.D., NSABPs vice-chairman. Following notification, many of the women in the placebo group began taking tamoxifen.
This situation was unique in that the results affected participants willingness to continue in the trial. Under these circumstances, clinicians are obligated to share the results with the patients. More often than not, however, trial results are not known until after a trial has ended, and the reality is that many participants leave trials never knowing how the study turned out. In contrast, patients are offered enormous amounts of information before they agree to enter a trial.
"We dont do a good job of telling patients what we learned from [clinical trials]," said Ezekiel J. Emanuel, M.D., Ph.D., chief of clinical bioethics at the National Institutes of Health. "We publish [the results] in the academic journals and, if were lucky, it gets picked up in the New York Times, but do we tell our patients what was learned in general? Very very rarely."
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The idea for the guidelines came from the Coalition of National Cancer Cooperative Groups, which drafted the guidelines several years ago for the dissemination of results when a trial closes early. The group has since been lobbying its member groups (which includes ECOG) to adopt these guidelines for their trials. So far, the Cancer and Leukemia Group B and the Gynecologic Oncology Group have taken up the guidelines. ECOG is the first group to take the guidelines one step further and apply them to all trials, not just ones that close early.
Researchers conducting national NCI-funded trials are also encouraged to share trial results; however, it is done on a trial-by-trial basis and is not done in a consistent way for all trials, said Ellen Feigal, M.D., acting director of NCIs Division of Cancer Treatment and Diagnosis.
She said that each trial has its own approach to communicating results and acknowledged that ECOGs recent approval and expansion of the coalitions guidelines demonstrates the push to formalize the process. "I think its a good thing to try and be more systematic about how we communicate our results in a way thats usable by investigators and by patients," she said. "Its a matter of focusing on this as an issue and developing a plan and making it go forward."
Part of the process will involve talking to patients to find out what percentage would like to receive the results and then the best approach to doing sowhether it is through their physician, a letter, a Web site, or some other means.
At the annual meeting of the American Society of Clinical Oncology in May, Ann H. Partridge, M.D., of the Dana-Farber Cancer Institute in Boston, presented results of a survey of women enrolled in a phase II breast cancer treatment trial regarding their preferences about receiving results of clinical trials.
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Moreover, the survey revealed that 89% of the respondents wanted their families to be informed of the results if the individual died during the trial. Eighty-five percent of the respondents said they wanted to hear the results from their physicians, and 70% said they would be willing to receive the results by mail.
The next phase of the study will involve giving patients the results and then surveying their attitudes. Another part of the study will involve surveying physicians and nurses attitudes about sharing results and their current practices.
One reason some researchers cite for not routinely providing results is a simple one. "For me personally, when Ive done my research, I just didnt even think of it," Emanuel said. "It just didnt occur to me. But unless it does occur to you, you just pass over it."
Another reason may be the length of time that passes before aggregate results become availablesometimes years after a trial has ended. By then, many patients may have lost contact with the physician that treated them, said Jeffrey Abrams, M.D., a senior investigator in the Cancer Therapy Evaluation Program at NCI.
Partridge cautioned against disseminating results without carefully considering the implications. This month in the Journal of the American Medical Association, Partridge and her colleague Eric Winer, M.D., also at the Dana-Farber Cancer Institute, discuss the steps needed before results can be disseminated routinely.
While sharing results might lead to a better understanding of clinical trials and increased participation in the trials, they say, it could also remind patients of a disease or treatment they would rather forget.
"One of the worries I have as an investigator is that some governing body or committee is going to say you need to tell people results without carefully evaluating what the results might mean to people," said Partridge.
She suggested that the choice of whether to learn about results should be built into the informed consent process so that patients have the opportunity to decline future contact. Also, guidelines should be developed for determining the best time to offer the results. In addition, future studies should look at different approaches to sharing results.
One successful approach is the one taken by the Nurses Health Study, a study of 120,000 women that is looking at various factors associated with cancer. Investigators from this ongoing epidemiologic study, which began in 1976, send out annual newsletters to all its participants, highlighting the studys major findings.
Graham Colditz, M.D., a professor at Harvard Medical School in Boston, and lead investigator of the Nurses Health Study, said he is convinced that sharing results is both worthwhile for maintaining the integrity of the studies and for providing participants with a sense of appreciation and understanding for how the data they are providing is being used.
Despite the challenges ahead, many researchers agree that sharing results is important. "We need to commit ourselves to doing this and to the idea that this is a good thing and a good idea for us to be engaged in," said Emanuel. "I think thats what we so far dont have, is people saying we ought to be doing this."
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