title: Reporting Guidelines for Clinical Pharmacokinetic Studies: The ClinPK Statement.
abstract: OBJECTIVE
  Transparent reporting of all research is essential for assessing the validity of any study. Reporting guidelines are available and endorsed for many types of research but are lacking for clinical pharmacokinetic studies. Such tools promote the consistent reporting of a minimal set of information for end users, and facilitate knowledge translation of research. The objective of this study was to create a guideline to assist in the transparent and complete reporting of clinical pharmacokinetic studies.
  
  
  METHODS
  Preliminary content to be considered was identified from a systematic search of the literature and regulatory documents. Stakeholders were identified to participate in a modified Delphi exercise and a virtual meeting to generate consensus for items considered essential in the reporting of clinical pharmacokinetic studies. The proposed checklist was pilot tested on 100 recently published clinical pharmacokinetic studies. Overall and itemized compliance with the proposed guidance was determined for each study.
  
  
  RESULTS
  Sixty-eight stakeholders from nine countries consented to participate. Four rounds of a modified Delphi survey and a series of small virtual meetings were required to generate consensus for a 24-item checklist considered to be essential to the reporting of clinical pharmacokinetic studies. When applied to the 100 most recently published clinical pharmacokinetic studies, 45 were determined to be compliant with at least 80 % of the checklist items. Explanatory text was prepared using examples of compliant reporting from these and other relevant studies.
  
  
  CONCLUSIONS
  The reader's ability to judge the validity of pharmacokinetic research can be greatly compromised by the incomplete reporting of study information. Using consensus methods, we have developed a tool to guide transparent and accurate reporting of clinical pharmacokinetic studies. Endorsement and implementation of these guidelines by researchers, clinicians and journals would promote more consistent reporting of these studies and allow for better assessment of utility for clinical applications.
authors: Department of Pharmacy, The Ottawa Hospital and Ottawa Hospital Research Institute, 501 Smyth Rd, Ottawa, ON, K1H 8L6, Canada, skanji@ottawahospital.on.ca.
authors: Salmaan
authors: S
authors: Kanji
authors: Meghan
authors: M
authors: Hayes
authors: Adam
authors: A
authors: Ling
authors: Larissa
authors: L
authors: Shamseer
authors: Clarence
authors: C
authors: Chant
authors: David J
authors: DJ
authors: Edwards
authors: Scott
authors: S
authors: Edwards
authors: Mary H H
authors: MH
authors: Ensom
authors: David R
authors: DR
authors: Foster
authors: Brian
authors: B
authors: Hardy
authors: Tyree H
authors: TH
authors: Kiser
authors: Charles
authors: C
authors: la Porte
authors: Jason A
authors: JA
authors: Roberts
authors: Rob
authors: R
authors: Shulman
authors: Scott
authors: S
authors: Walker
authors: Sheryl
authors: S
authors: Zelenitsky
authors: David
authors: D
authors: Moher
mesh_terms: D035843:Biomedical Research / Q000592:standards*; D057189:Checklist; D003697:Delphi Technique; D005104:Expert Testimony; D017408:Guidelines as Topic; D006801:Humans; D010599:Pharmacokinetics; D010601:Pharmacology, Clinical / Q000592:standards; D010865:Pilot Projects
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