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

Int J Clin Pharmacol Ther. 2017 Aug;55(8):639-642. doi: 10.5414/CP203073.

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 <bold>10-D assessment,</bold> which comprises peer review criteria to determine if: 1. <bold>d</bold>esign of the study, 2. <bold>d</bold>iagnoses employed, 3. <bold>d</bold>rug molecules involved, 4. <bold>d</bold>osages applied, 5. <bold>d</bold>ata collected, 6. <bold>d</bold>iscussion of the findings, 7. <bold>d</bold>eductions made, 8. <bold>d</bold>ocumentation, 9. <bold>d</bold>eclarations, and 10. <bold>d</bold>HS (drug hypersensitivity syndrome) risk assessment is in accord with the objectives of the study and meet the requirements of EBM and GPP.

Conclusions: The <bold>10-D assessment</bold> 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. .

MeSH terms

  • Biomedical Research / methods
  • Evidence-Based Medicine / methods*
  • Humans
  • Peer Review, Research / methods*
  • Pharmacology, Clinical / methods*
  • Publishing