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Protocol information provides opportunity for patient safety and quality improvement.

TO THE EDITOR: We enthusiastically support and applaud the recent decision by the editors of Journal of Clinical Oncology (JCO) to make available for online readers the entire protocol for published randomized phase II and III trials. This landmark event in clinical trial reporting will not only improve the dissemination of medical knowledge, but will likely simultaneously improve the safe translation of clinical trial data to that of practicing hematologists and oncologists. Noting the details of clinical trial protocol design, statistical methodology, and measurable end points has long been recognized as a critical responsibility of the scientific community. Analysis of such detail is imperative to gauge the scientific merit and accuracy of the data and subsequent conclusions. However, it has recently been recognized that the lack of information in trial publications about patient selection, treatment, monitoring, and management may impact the quality of cancer care that is delivered after publication. The generalizability of published study results to individual patients with any degree of certainty is dependent on many more variables than can possibly be included in an article limited to 3,000 words. Vague exclusion criteria, limited clinical monitoring information, and scarce information on dose modifications for toxicity each create opportunities for disparate outcomes in translating the science to the clinic. If schedule-dependent treatments are not made explicitly clear, differences in efficacy may result. In our study of 262 oncologybased therapeutic randomized controlled trials published in JCO, Journal of the National Cancer Institute, Blood, Cancer, and New England Journal of Medicine, only 11% consistently reported essential therapeutic details. By including the complete protocol for readers as a requirement for publication in JCO, a new standard for quality of cancer care in the oncology community has been established. Having immediate and convenient access to the protocol will make it more likely that practicing clinicians will be able and willing to review the study details relevant to the provision of high-quality, safe clinical care. Our hope is that other journals will follow the lead provided by JCO.