Good publication practices in clinical pharmacology: transparency, evidence-based medicine and the 7-D assessment

Abstract

Transparency and evidence-based medicine are cornerstones of good publication practices (GPP), and concern publishers, editors, research investigators, and reviewers alike. Methods for implementing these principles within the framework of GPP are described. The main aspects include obtaining a Manuscript Agreement Contract, a Statement on Transparency of Authorship and a Declaration of Conflicts of Interest from the authors. Assessing whether a manuscript meets the requirements of EBM is demonstrated using the “7-D assessment”. The main purpose of this tool is to established that the (1) right Design, (2) right Diagnosis, (3) right Drug molecule, (4) right Dosage, (5) right Data, (6) right Deductions, and (7) right Documentation have been implemented in order to meet the objectives of the investigation. If the findings from any one of these assessments is questionable, the compliance of the research with EBM principles will be weakened and the reviewers and editors will make recommendations to the publisher accordingly. The guidelines described will help to provide a fair and transparent process of scientific publication and foster the freedom of clinical pharmacological research.

Essential Characteristics of Pharmacogenomics Study Publications

“…Second, a recent article by Woodcock and Harder proposes the “10D assessment,” suggesting the following criteria should be fully described by authors publishing studies of clinical pharmacology that also apply to clinical PGx: 1. d esign of the study, 2. d iagnoses employed, 3. d rug molecules involved, 4. d osages applied, 5. d ata collected, 6. d iscussion of the findings, 7. d eductions made, 8. d ocumentation, 9. d eclarations, and 10. d HS (drug hypersensitivity syndrome) risk assessment (9). The article concludes that the assessment will help articles meet the standards for Evidence-Based Medicine (EBM) (10) and Good Publication Practices (GPP) (11).…”

“…9 The article concludes that the assessment will help articles meet the standards for evidencebased medicine 10 and good publication practices. 11 Third, publications reporting PGx studies should follow the FAIR principles: the FAIR principles are a commitment to make data Findable, Accessible, Interoperable, and Reproducible (FAIR). 12 Briefly, FAIRness is achieved by describing studies with rich metadata that use standardized vocabularies, identifiers that are stable and maintained, protocols that are freely available and well described, and data that can be retrieved and retested.…”

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

“…The herein described 10-D assessment tool for peer reviewers, authors, and publishers of clinical pharmacology manuscripts is a further development of the 7-D assessment [ 1 ] and 8-D assessment reported previously [ 2 ].…”

“…The publication of clinical findings is a driving force in pharmacotherapy, and therefore the peer review process is a determinant for safety in drug development and pharmacotherapy. The peer review process must therefore meet the requirements of Evidence-Based Medicine (EBM) [ 5 ] and Good Clinical Practices (GPP) [ 1 ].…”

Peer review in Clinical Pharmacology using the 8-D Assessment

“…Peer review criteria for clinical pharmacology were recently put forward by Woodcock and Luger [ 5 ]. This tool, now slightly modified, is described here.…”