Adequacy of published oncology randomized controlled trials to provide details needed for clinical application

Abstract

6536 Background: Randomized control trials (RCTs) provide evidence for life-saving and supportive therapies. Although manuscript submissions follow a standard scientific format, major oncology journals have minimal standards for reporting treatment administration. Published data investigating chemo and biologic therapy often lack details needed for effective and safe clinical application. Methods: All therapy-based phase III oncology RCTs published between 2005–2008 in the Journal of Clinical Oncology (JCO), The New England Journal of Medicine (NEJM), Journal of the National Cancer Institute (JNCI), Blood, and Cancer were eligible for inclusion. Physicians and oncology pharmacists were surveyed for details needed for clinical practice. Each article was evaluated for these mandatory elements ( Table ). Differences were calculated using the Chi-squared test. Results: Literature search identified 339 eligible articles, 77 were reviews or meta-analyses. 262 were included in the final analysis (165 JCO; 31 NEJM; 27 Cancer; 20 JNCI; 19 Blood). Only 31 (12%; median score 7.3) met the main objective of complete data reporting. The most consistently reported and missing elements are described in Table 1. Premedications, growth factor support, and dose adjustments for hematologic or organ toxicity were reported less than half the time (p<0.0001). The presence of an online appendix did not significantly improve the results (data not shown). Conclusions: RCTs published in top tier oncology journals fail to consistently report full details needed for clinical application. Manuscript submission guidelines should be modified to promote consistent reporting with potential use of online appendices. Standardized editorial policy may allow safe and effective translation of trial drug findings into clinical practice. [Table: see text] No significant financial relationships to disclose.