The 10-D assessment and evidence-based medicine tool for authors and peer reviewers in clinical pharmacology .

Abstract

Background: Peer reviewers and authors of clinical pharmacology manuscripts need to meet the standards for Evidence-Based Medicine (EBM) and Good Publication Practices (GPP), and editors of clinical pharmacology journals have to maintain an overview of the peer review process. Methods and results: The peer review process can be monitored and facilitated using the 10-D assessment, which comprises peer review criteria to determine if: 1. design of the study, 2. diagnoses employed, 3. drug molecules involved, 4. dosages applied, 5. data collected, 6. discussion of the findings, 7. deductions made, 8. documentation, 9. declarations, and 10. dHS (drug hypersensitivity syndrome) risk assessment is in accord with the objectives of the study and meet the requirements of EBM and GPP. Conclusions: The 10-D assessment tool, although easy to apply, requires a high level of clinical pharmacology expertise, especially in the fields of drug disposition, pharmacokinetics, and drug action. Its application will facilitate the peer review of clinical research and clinical trial reports and thus promote safety in drug development and pharmacotherapy and meet the needs of Good Publication Practices.