Reporting of clinical trial data: Are we fully utilizing the current clinical trial data to help manage the older adult cancer population?

Abstract

19546 Background: The number of older cancer patients will continue to increase as the population ages. Thus the demand for information on how to manage this population will continue to increase in importance. Clinical trials provide pertinent information to clinicians on treatment options, however, are the current available results matching the needs for the older cancer population? Methods: An evaluation was performed of published clinical trials to determine whether the data was analyzed, reported and discussed using age related criteria. Prospective studies involving 50 or more patients published from 01/2005–12/2006 in the Journal of Clinical Oncology (JCO), Cancer, and the Journal of the National Cancer Institute (JNCI) were reviewed. Results: There were 258 JCO, 58 Cancer, and 17 JNCI articles with the prespecified criteria. The median number of patients enrolled per trial is 212 (JCO), 77.5 (Cancer), and 954 (JNCI). The mean age of patients enrolled for all studies was 59.4 years (range 16 to 93 years). The number (%) of studies which stratified for age is 54 (20.9%) for JCO, 17 (29.3%) for Cancer, and 7 (41%) for JNCI. The number (%) of studies which included age in their analyses is 75 (29%) for JCO, 14 (24%) for Cancer, and 6 (35.3%) for JNCI. Age was mentioned in the discussion section in 40 (15.5%), 8 (13.8%), and 6 (35.3%), JCO, Cancer, and JNCI articles, respectively. Conclusions: The current clinical trials fail to provide ample data which clinicians need to best manage the older cancer population. Since there was a lack of age related analyses, valuable data may have gone unreported. ASCO and other organizations recognize the lack of data on the management of older cancer patients. The underrepresentation of this population in clinical trials certainly contributes to this lack of data. Data mining of these existing studies involving large numbers of patients may provide valuable age related information for clinicians. The continued development of trials involving the older cancer population will aid in increasing our knowledge. We would also like to put forth that journal reviewers and editors should require the incorporation and reporting of age related analyses in studies, especially those involving large number of patients. No significant financial relationships to disclose.