Clinical Trial Reports publishes not only positive phase II trials in brief but also phase II trials that do not have positive therapeutic outcomes but provide valuable insight into pharmacology, drug interactions, and reasons for drug failure.  This information should not be lost to the community of investigators and practitioners.

Clinical Trial Reports and all supportive documentation will be published online at www.TheOncologist.com. In these reports, we ask that the sponsor, coordinating site, participating sites and investigators be clearly identified.  Extended abstracts of approximately 400 words and a single salient graphic, such as a table, schema, waterfall plot, image, or graph will also be published in the Journal’s print edition. Each abstract should consist of four sections: Background, Methods, Results, and Discussion.

Review Process

Only well-executed studies, as attested by peer review, will be accepted for publication. These manuscripts will be rigorously reviewed by The Oncologist’s internationally recognized editorial board (www.TheOncologist.com/misc/edboard.dtl), as well as by ad hoc reviewers with relevant expertise.

The criteria used by reviewers to evaluate the potential value of the study include the number of patients in the study, differences or trends seen in patient subsets, p-values, primary outcome(s) of the study, and statistical analyses.

Time from submission to publication

Since it is essential that the results of these studies be reviewed and published with dispatch, peer review will be completed within 3 weeks of manuscript receipt. Accepted papers will then be published ahead-of-print online within 2 weeks. Hence, the gestation from manuscript submission to online publication will be approximately 5 weeks.

NOTE: As standard practice, submitting authors will complete a Potential Conflict of Interest and Financial Disclosure.

Instructions for Submission

We hope you find the process user-friendly. As this is a new process, we anticipate making changes and welcome your feedback.

Report Overview – Please provide all details in this section to properly identify the trial

• Abstract (structured abstracts requested)
• ClinicalTrials.gov identifier
• Sponsor
• Collaborators
• Principal Investigators and co-authors

Report Information

• All are optional pull-down menus, with exception of Additional Details of Endpoints or Study Design.

Patient Characteristics

• A combination of pull-down menus and fill-ins.

Primary Assessment Method

• A combination of pull-down menus and fill-ins.
• Note: If you choose to have a waterfall plot drawn, it will automatically appear in the Figures/Tables Section, and you will be able to assign it the figure number you choose.

Secondary Assessment Method

• To be used for secondary methods such as PSA or CA125 values, secondary imaging methods, or other novel assessments.
• A combination of pull-down menus and fill-ins.

Adverse Events

• Generally, adverse events occurring in 5% or 10% of enrolled patients should be included.
• Enter the number of patients who experienced or did not experience the adverse event and the program will calculate the percentages in a summary table provided in the report.
• NA/NC: No adverse event or no change from baseline.

Pharmacokinetics/Pharmacodynamics

• Report PK/PD information in text box format.

Figures/Tables

• If a waterfall plot was selected in the Primary Assessment Method section, it will appear here.
• Please include beside the figure, a relevant figure legend.

Assessment/Analysis/Discussion

• Choose from the pull-down menus to describe whether the study was completed, considered active or inactive, and the investigator’s analysis of that assessment.

• Discussion — A brief discussion addresses the findings of the study, shortcomings, if any, and reasons why the results might have been negative, and explores possible next steps regarding how and why this study may be useful to patient care and further research. Include in the discussion a response to this question: “If this could be done over again, would you use the same or different design?” If the trial did not complete planned accrual, a calculation of the statistical power of the incomplete trial to answer the question posed should be provided.

• Key references, defined as those that are essential for the review process or for reader understanding, can be included. References should be in The Oncologist format and inserted in the Discussion text box at the end of the brief discussion.