Sharing Study Results With Trial Participants: Time for Action
Authors: Ann H. Partridge, Eric P. Winer
Journal: Journal of Clinical Oncology (2009)

A growing body of research suggests that individuals treated for cancer are interested in learning results of clinical trials in which they have participated. Despite this research, return of research results to clinical trial participants is rarely pursued. There has been increasing interest among patient advocates, researchers, and ethicists in altering the current landscape. Research has consistently demonstrated that the majority of patients are interested in being offered trial results, and believe they have a right to the information. However, concerns about adverse psychological consequences of communicating trial results have limited the enthusiasm. Moreover, there are logistic concerns. Who should provide the results? When should we provide the results? How should we provide them? In an ideal world, each of these questions would be addressed definitively through research before a system for routinely providing results were implemented. In this issue of Journal of Clinical Oncology, Fernandez et al report their investigation of the views of potential trial participants about the disclosure of research results. Their survey of more than 500 adolescent patients or parents of children with cancer reveals that the vast majority of pediatric cancer survivors or their parents would want results of clinical trials. Although only a minority of respondents (or their children) had participated in a clinical trial, a number of previous studies have revealed similar interest in receiving study results among actual trial participants. The work of Fernandez et al also delineates the type of information desired, and how patients and their families would like to learn results. Should we be worried about the negative psychological impact of sharing results? For good reason, the greatest concern is for those individuals who either did not benefit from therapy or had a bad outcome as part of a trial. In a recent study, a summary letter was sent to all study participants. Women who had been randomly selected to receive the inferior treatment were found to have greater dissatisfaction with the manner in which results were shared, and reported increased anxiety about their disease after receiving results. These findings, in conjunction with the survey results of Fernandez et al, suggest that more careful and controlled disclosure of results is necessary among patients who received the less effective treatment or had a poor outcome. For these patients, mailed or Web-based information may be inadequate, and a plan should be in place to offer direct contact with a medical professional who can provide more detailed explanations, answer questions in a timely manner, and assess the patients’ level of emotional distress. However, it would seem ill advised to shield patients—even those who may have received a treatment that in retrospect was not the best approach—from trial results. We should remember that once presented at a meeting, the results of a trial are in the public domain, and in the case of large trials, the results are often covered extensively by the lay media. Patient advocacy groups have expressed dismay at the paternalistic, and somewhat unrealistic, desire of researchers to protect their patients from anxiety about their disease. We believe a plan to share results should be included in the design of all phase III clinical trials. In general, this plan should involve a two-step process. First, participants should be offered an opportunity to learn the results, with a clear option to decline receipt, because it is recognized that not all patients want trial results. The second step should involve the provision of results, either by mail, Internet, telephone call, or in-person meeting. Optimally, flexibility should be built into the process to allow patients with different learning styles and potentially divergent trial experiences to receive the results in the manner that is best for them individually. The strategy to share results should be written into the protocol and delineated for participants in the informed consent process at the outset of the trial. Instituting mechanisms to routinely share trial results has several potential direct and indirect benefits. Sharing results may facilitate communication between clinicians and patients, increase patient satisfaction with study participation, and ultimately lead to greater public understanding and greater clinical trial participation. Not only does sharing show appreciation and respect for patients involved in research, but it also provides an opportunity for participants to receive new information that might be of great concern directly from their health care team. Sharing results has the potential to decrease both anxiety and misinterpretation of the data. Whenever possible, an effort should be made to disseminate trial results to study participants just before or at the same time that the data are released to the media and the general public, because there have been some trial participants who have expressed anger at learning results from media sources rather than from their providers. Early efforts to share results, which include posting study summaries in plain language on cooperative group Web sites and mailing results from both cooperative group and institutional studies, are underway. Given the natural history of certain cancers, the issue of whether next of kin should be offered results when a study participant has died is a topic for additional study. There is little question that the entire process will require commitment on the part of the investigators and have associated costs. Yet the resources required are likely to be JOURNAL OF CLINICAL ONCOLOGY E D I T O R I A L VOLUME 27 NUMBER 6 FEBRUARY 2