Providing Protocol Information for Journal of Clinical Oncology Readers: What Practicing Clinicians Need to Know

Abstract

Soon, readers of Journal of Clinical Oncology (JCO) will have access to information that has heretofore been available only to the editors and the reviewers. For those of you who have submitted manuscripts to JCO, you have noted the following requirement that has been in place since 2009: “JCO believes that, for the editors and reviewers to properly peer review a submission, a redaction of the protocol or the entire protocol for all (randomized) phase II and III studies must be provided. This applies to reports of primary, planned end points of the study, as well as planned or unplanned subset analyses, at the discretion of the editors. The protocol information must include the eligibility criteria, schema and dose modifications, and a statistical section (including end points). Authors should upload this material as a supplemental file. It will only be available to the editors and reviewers during the peer review process.” Why was this added to the long list of requirements for manuscript submission? Many aspects of protocols that describe the reported research are greatly simplified in the published papers because of space requirements. Without knowing information such as the full eligibility criteria, for instance, it is difficult to determine whether a given patient would have been eligible, or whether the results of the protocol might be broadly applicable to patients seen in a clinician’s typical practice. The same can be said for the rules followed for dose modifications on protocol, which are frequently described only briefly in the text. For reviewers in particular, having knowledge of the full original statistical requirements for the study—especially the predefined end points—is mandatory to adequately assess the manuscript. Although the editors were initially concerned that requiring redacted portions of phase II and III protocols might cause some authors to avoid manuscript submissions to JCO, this appears to have not occurred, and indeed, most investigators have even been willing to submit the entire protocol as a supplemental file for our review. However, the editors felt that the requirement for even a redaction of a protocol might be problematic for phase I and some translational studies, because many investigators and sponsors might be wary of releasing potentially proprietary information. Given that such studies report on drugs or techniques not generally available to practitioners, the editors felt that this exclusion did not violate the spirit of redacted protocol submission for randomized phase II and III studies. We now feel that it is time to set a new standard in medical journal reporting by allowing readers to access this information online for all randomized phase II and III trials. Each file will be preceded by a disclaimer, noting that the protocol information is provided solely to describe how the authors conducted the research underlying the published report. The information provided may not reflect the complete protocol or any previous amendments or modifications, and it is not intended to replace good clinical judgment in selecting appropriate therapy and in determining drug doses, schedules, and dose modifications. As always, the treating physician or other health care provider is ultimately responsible for determining the best treatment for the patient. Individuals seeking additional information about the protocol are encouraged to consult with the authors directly. In summary, for randomized phase II and III trials, JCO will now permit readers access to the following redacted portions of the most recent protocol: selection of patients, including both eligibility and ineligibility criteria; schema and treatment plan, including administration schedule; rules for dose modification; measurement of treatment effect, including response criteria, definitions of response and survival, and methods of measurement; reasons for early cessation of trial therapy; and objectives and the entire statistical section, including end points. The editors believe that this initiative will allow JCO to evolve its already high standards for credibility and transparency of clinical trials reporting and to maintain its reputation as the authoritative resource for clinical hematologists and oncologists.