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Originally published as JCO Early Release 10.1200/JCO.2008.20.0865 on January 21 2009 © 2009 American Society of Clinical Oncology.
Sharing Study Results With Trial Participants: Time for ActionDana-Farber Cancer Institute; Brigham and Women's Hospital; and Harvard Medical School, Boston, MA 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.1 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.2 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.1,3,4 In this issue of Journal of Clinical Oncology, Fernandez et al5 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.6–9 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.10 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.9 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.5,9 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.7,11,12 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.13 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.14,15 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 trivial compared with the cost of actually treating a patient enrolled onto a study. In our view, the benefits far outweigh the risks. Additional editorials and commentaries about whether to offer trial results are not needed. We have sufficient evidence to incorporate results disclosure into the design of clinical trials. Additional research is critical, but we do not need to have all the answers before moving forward with implementation. The necessary research can be conducted within the context of ongoing efforts to share results. In the current era, we would not conceive of conducting a clinical trial without appropriate informed consent. Similarly, we believe that the time has come to require that phase III studies include a defined plan to share results with the very people who make clinical trials possible. AUTHORS' DISCLOSURES OF POTENTIAL CONFLICTS OF INTEREST The author(s) indicated no potential conflicts of interest. AUTHOR CONTRIBUTIONS Conception and design: Ann H. Partridge, Eric P. Winer Manuscript writing: Ann H. Partridge, Eric P. Winer Final approval of manuscript: Ann H. Partridge, Eric P. Winer REFERENCES
1. Partridge AH, Hackett N, Blood E, et al: Oncology physician and nurse practices and attitudes regarding offering clinical trial results to study participants. J Natl Cancer Inst 96:629–632, 2004. 2. Shalowitz DI, Miller FG: Communicating the results of clinical research to participants: Attitudes, practices, and future directions. PLoS Med 5:e91; 2008.[CrossRef][Medline] 3. Markman M: Providing research participants with findings from completed cancer-related clinical trials: Not quite as simple as it sounds. Cancer 106:1421–1424, 2006.[CrossRef][Medline] 4. Dixon-Woods M, Jackson C, Windridge KC, et al: Receiving a summary of the results of a trial: Qualitative study of participants' views. BMJ 332:206–210, 2006. 5. Fernandez CV, Gao J, Strahlendorf C, et al: Providing research results to participants: Attitudes and needs of adolescents and parents of children with cancer. J Clin Oncol 27:878–883, 2009. 6. Partridge AH, Burstein HJ, Gelman RS, et al: Do patients participating in clinical trials want to know study results? J Natl Cancer Inst 95:491–492, 2003. 7. Partridge AH, Wong JS, Knudsen K, et al: Offering participants results of a clinical trial: Sharing results of a negative study. Lancet 365:963–964, 2005.[CrossRef][Medline] 8. Johnson L, Barrett-Lee P, Ellis P, et al: How do patients want to learn of results of clinical trials? A survey of 1431 breast cancer patients. Br J Cancer 98:34–38, 2008.[CrossRef][Medline] 9. Partridge AH, Wolff AC, Marcom PK, et al: The impact of sharing results of a randomized breast cancer clinical trial with study participants. Breast Cancer Res Treat [epub ahead of print on June 10, 2008]. 10. Romond EH, Perez EA, Bryant J, et al: Trastuzumab plus adjuvant chemotherapy for operable HER2-positive breast cancer. N Engl J Med 353:1673–1684, 2005. 11. Oddens BJ, Algra A, van Gijn J: Informing patients about clinical trials. Clin Investig 71:572–573, 1993.[Medline] 12. Taylor KM, Kelner M: Informed consent: The physician's perspective. Soc Sci Med 24:135–143, 1987.[CrossRef][Medline] 13. Fernandez CV, Kodish E, Weijer C: Importance of informed consent in offering to return research results to research participants. Med Pediatr Oncol 41:592–593, 2003.[Medline] 14. Goodare H, Smith R: The rights of patients in research. BMJ 310:1277–1278, 1995. 15. Rich KR: Lives. Close to the bone 6:102; 1999 12 19, New York Times.
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Copyright © 2009 by the American Society of Clinical Oncology, Online ISSN: 1527-7755. Print ISSN: 0732-183X
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