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Journal of Clinical Oncology, Vol 24, No 6 (February 20), 2006: pp. 846-847 © 2006 American Society of Clinical Oncology. DOI: 10.1200/JCO.2005.04.5120
Increasing Trial GeneralizabilityPrevention and Control Program, Cancer Research Center of Hawaii, Honolulu, HI The percentage of American cancer patients who enroll on clinical trials is only a small fraction of the total number of patients—as low as 1.7% according to a recent report of participation in clinical trials for the most common cancers.1 A Comments and Controversies article by Wright et al2 draws attention to this important issue and suggests that more complete information about the total patient pool and the proportions that are eligible and enrolled on trials would be useful in understanding barriers to accrual. This kind of data could be informative. However, it is only readily available in certain settings, where an institution or health care system has a defined cancer patient catchment population and a process to document all cancer care and decision-making about trials. It is perhaps not surprising that the only two examples that Wright et al found that met their recruitment reporting criteria were based in Japan and Sweden, two countries with a centralized approach to health care. In a decentralized health care system with multiple reimbursement options, such as that found in the United States, collecting such information is very challenging. In many communities, cancer patients are evaluated and enrolled on clinical trials across multiple locations. More than one hospital, clinic, and oncologist office often serves the same cancer patient population, and boundaries between the different institutions are porous. For example, patients may be diagnosed in one medical center and treated in another, seek second (and third opinions), and receive different modalities in different locations. Furthermore, patients may receive treatment in distant cities near family members or seek specialized care at tertiary referral centers. Discussions and evaluations for clinical trial participation can occur at any point or at multiple points along the treatment trajectory. This calculating the "denominator" (the number of patients potentially eligible and meeting eligibility criteria for a trial in a particular center) is very hard to do when there are multiple points of entry and exit within the health care system. It is possible that the increased use of standardized electronic medical records, and linkage among various sources of data may facilitate this process at some point in the future. Wright et al also raise another important concern that has received far too little attention—examining the extent to which clinical trials results can be used in the broader context of cancer care outside the trial itself. There are at least two approaches that can be taken to answer the question, "How can trial results be applied to patients in clinical practice?" Conducting Effectiveness Studies Most phase III cancer clinical trials are studies of efficacy that examine whether a therapy can work under certain circumstances, as opposed to examining effectiveness; that is, how an intervention works in clinical practice.3 Effectiveness research such as studies of patterns of care and barriers to implementing trial results can be very informative in identifying the conditions for applying trial results more broadly. For example, considerable attention has been given to understanding why the use of breast-conserving surgery plus radiation for early-stage breast cancer is not higher, despite compelling clinical trial findings. A recent review indicated that age, comorbidity, and geography, as well as changes in practice patterns over time, all were associated with the receipt of breast conserving therapy.4 Continued investigation is needed to see how results of clinical trials are translated into nontrial care and with what results. Developing Trials That Fit Patients Seen in Practice To the extent that trial participants share the same characteristics as the majority of patients, the application of trial results to practice should be facilitated. This could be achieved if trials had few restrictions on eligibility, allowing almost all patients to participate. Such "large simple trials" have been suggested for cancer research.5,6 However, this approach has not been common in cancer therapy research to date. Another strategy is the development of trials that are targeted and appropriate to the needs of special populations. Elderly patients have been identified as such a group, which makes up the majority of cancer patients but only a small percentage of clinical trial participants.1,7,8 Recent attention has focused on new trials for elderly patients that are tailored to particular characteristics of this population, such as the presence of comorbid conditions. A search of the current National Institutes of Health clinical trials database revealed no fewer than 179 cancer trials directed at "older" patients currently recruiting in the United States.9 New cancer treatment recommendations for the elderly should be available when these trials are completed. In sum, Wright et al2 have raised issues that are important to enhancing the completion of clinical trials and the dissemination of study findings. Cancer patients await improved cancer therapies, and identifying ways to achieve faster and more generalizable clinical trial findings is an imperative. Author's Disclosures of Potential Conflicts of Interest The author indicated no potential conflicts of interest. Author Contributions
REFERENCES
1. Murthy VH, Krumholz HM, Gross CP: Participation in cancer clinical trials race-, sex-, and age-based disparities. JAMA 291:2720-2726, 2004 2. Wright JR, Bouma S, Dayes I, et al: The importance of reporting patient recruitment details in phase III trials. J Clin Oncol 24:843-845, 2006 3. Wells KB: Treatment research at the crossroads: The scientific interface of clinical trials and effectiveness research. Am J Psychiatry 156:5-10, 1999 4. Edwards BK, Brown ML, Wingo PA, et al: Annual report to the nation on the status of cancer 1975-2002, featuring population-based trends in cancer treatment. J Natl Cancer Inst 97:1407-1427, 2005 5. Peto R, Colins R, Gray R: Large-scale randomized evidence: Large, simple trials and overviews of trials. J Clin Epidemiol 48:23-40, 1995[CrossRef][Medline] 6. Report of the National Cancer Institute Clinical Trials Program Review Group. August 26, 1997. Available at http://deainfo.nci.nih.gov/advisory/BSA/bsa_program/bsactprgmin.htm 7. Hutchins LF, Unger JM, Crowley JJ, et al: Underrepresentation of patients 65 years of age or older in cancer-treatment trials. N Engl J Med 341:2061-2067, 1999 8. Yee KW, Pater JL, Pho L, et al: Enrollment of older patients in cancer treatment trials in Canada: Why is age a barrier? J Clin Oncol 21:1618-1623, 2003 9. ClinicalTrials.gov Web site. Available at http://www.clinicaltrials.gov This article has been cited by other articles:
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Copyright © 2006 by the American Society of Clinical Oncology, Online ISSN: 1527-7755. Print ISSN: 0732-183X
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