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Reporting Guidelines for Clinical Pharmacokinetic Studies: The ClinPK Statement

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Abstract

Background and 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 ite mized 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.

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References

  1. Upton D, Upton P. Knowledge and use of evidence-based practice of GPs and hospital doctors. J Eval Clin Pract. 2006;12:376–84.

    Article  PubMed  Google Scholar 

  2. Moher D, Liberati A, Tetzlaff J, Altman DG, Prisma Group. Preferred reporting items for systematic reviews and meta-analyses: the PRISMA statement. BMJ. 2009;339:b2535.

    Article  PubMed Central  PubMed  Google Scholar 

  3. Schulz KF, Altman DG, Moher D, CONSORT Group. CONSORT 2010 statement: updated guidelines for reporting parallel group randomized trials. Ann Intern Med. 2010;152:726–32.

    Article  PubMed  Google Scholar 

  4. Rowland M, Tozer T. Clinical pharmacokinetics and pharmacodynamics: concepts and applications. 4th ed. USA: Lippincott Williams and Wilkins; 2010.

    Google Scholar 

  5. Li AM, Gomersall CD, Choi G, Tian Q, Joynt GM, Lipman J. A systematic review of antibiotic dosing regimens for septic patients receiving continuous renal replacement therapy: do current studies supply sufficient data? J Antimicrob Chemother. 2009;64:929–37.

    Article  CAS  PubMed  Google Scholar 

  6. Moher D, Schulz KF, Simera I, Altman DG. Guidance for developers of health research reporting guidelines. PLoS Med. 2010;7:e1000217.

    Article  PubMed Central  PubMed  Google Scholar 

  7. Guideline on reporting the results of population pharamacokinetic analyses. 2007. Available at: http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/09/WC500003067.pdf. Accessed 30 Jan 2013.

  8. Note for guidance on the evaluation of the pharmacokinetics of medicinal products in patients with impaired renal function. 2004. Available at: http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/09/WC500003123.pdf. Accessed 30 Jan 2013.

  9. ICH guidance E6: good clinical practice. Consolidated guideline. 2004. Available at: http://www.hc-sc.gc.ca/dhp-mps/alt_formats/hpfb-dgpsa/pdf/prodpharma/e6-eng.pdf. Accessed 31 Jan 2013.

  10. Clinical pharmacokinetic studies of pharmaceuticals. 2001. Available at: http://www.nihs.go.jp/phar/pdf/ClPkEng011122.pdf. Accessed 30 Jan 2013.

  11. Guidance for industry: population pharmacokinetics. 1999. Available at: http://www.fda.gov/cder/guidance/. Accessed 30 Jan 2013.

  12. Murphy MK, Black NA, Lamping DL, et al. Consensus development methods, and their use in clinical guideline development. Health Technol Assess. 1998;2:1–4, 1–88.

  13. Jonsson EN, Wade JR, Karlsson MO. Comparison of some practical sampling strategies for population pharmacokinetic studies. J Pharmacokinet Biopharm. 1996;24:245–63.

    Article  CAS  PubMed  Google Scholar 

  14. Gerlowski LE, Jain RK. Physiologically based pharmacokinetic modeling: principles and applications. J Pharm Sci. 1983;72:1103–27.

    Article  CAS  PubMed  Google Scholar 

  15. Karlsson MO, Jonsson EN, Wiltse CG, Wade JR. Assumption testing in population pharmacokinetic models: illustrated with an analysis of moxonidine data from congestive heart failure patients. J Pharmacokinet Biopharm. 1998;26:207–46.

    Article  CAS  PubMed  Google Scholar 

  16. Brendel K, Dartois C, Comets E, et al. Are population pharmacokinetic and/or pharmacodynamic models adequately evaluated? A survey of the literature from 2002 to 2004. Clin Pharmacokinet. 2007;46:221–34.

    Article  PubMed Central  PubMed  Google Scholar 

  17. Dartois C, Brendel K, Comets E, et al. Overview of model-building strategies in population PK/PD analyses: 2002–2004 literature survey. Br J Clin Pharmacol. 2007;64:603–12.

    Article  CAS  PubMed Central  PubMed  Google Scholar 

  18. Cockcroft DW, Gault MH. Prediction of creatinine clearance from serum creatinine. Nephron. 1976;16:31–41.

    Article  CAS  PubMed  Google Scholar 

  19. Levey AS, Bosch JP, Lewis JB, Greene T, Rogers N, Roth D. A more accurate method to estimate glomerular filtration rate from serum creatinine: a new prediction equation. Modification of Diet in Renal Disease Study Group. Ann Intern Med. 1999;130:461–70.

    Article  CAS  PubMed  Google Scholar 

  20. Diamandopoulos A, Goudas P, Arvanitis A. Comparison of estimated creatinine clearance among five formulae (Cockroft–Gault, Jelliffe, Sanaka, simplified 4-variable MDRD and DAF) and the 24 hours-urine-collection creatinine clearance. Hippokratia. 2010;14:98–104.

    CAS  PubMed Central  PubMed  Google Scholar 

  21. Green B, Duffull SB. What is the best size descriptor to use for pharmacokinetic studies in the obese? Br J Clin Pharmacol. 2004;58:119–33.

    Article  PubMed Central  PubMed  Google Scholar 

  22. Ette EI, Sun H, Ludden TM. Ignorability and parameter estimation in longitudinal pharmacokinetic studies. J Clin Pharmacol. 1998;38:221–6.

    Article  CAS  PubMed  Google Scholar 

  23. Keizer RJ, Zandvliet AS, Beijnen JH, Schellens JH, Huitema AD. Performance of methods for handling missing categorical covariate data in population pharmacokinetic analyses. AAPS J. 2012;14:601–11.

    Article  CAS  PubMed Central  PubMed  Google Scholar 

  24. Kim A, Chung I, Yoon SH, et al. Effects of proton pump inhibitors on metformin pharmacokinetics and pharmacodynamics. Drug Metab Dispos. 2014;42:1174–9.

    Article  PubMed  Google Scholar 

  25. Ritschel WA. Bioavailability/bioequivalence of modified release drug delivery systems: which pharmacokinetic parameters to determine, single or multiple dose studies, pretests, conditions and other aspects. Methods Find Exp Clin Pharmacol. 1992;14:469–82.

    CAS  PubMed  Google Scholar 

  26. Als-Nielsen B, Chen W, Gluud C, Kjaergard LL. Association of funding and conclusions in randomized drug trials: a reflection of treatment effect or adverse events? JAMA. 2003;290:921–8.

    Article  PubMed  Google Scholar 

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Acknowledgments

We would like to extend our sincere thanks to all of the Delphi panellists for their participation and commitment to the development of these guidelines. We greatly appreciate the time and effort they invested into this Project as the Project could not have been successful without their continued involvement. This work was funded in part by a research Grant from the Canadian College of Clinical Pharmacy. Jason A. Roberts is funded by a Career Development Fellowship from the National Health and Medical Research Council of Australia (APP1048652). David Moher is supported by a University of Ottawa Research Chair. No other real or potential conflicts of interest are declared by the authors.

Author information

Authors and Affiliations

  1. Department of Pharmacy, The Ottawa Hospital and Ottawa Hospital Research Institute, 501 Smyth Rd, Ottawa, ON, K1H 8L6, Canada

    Salmaan Kanji

  2. The Ottawa Hospital, Ottawa, ON, Canada

    Meghan Hayes

  3. University of Waterloo, Waterloo, ON, Canada

    Adam Ling

  4. The Ottawa Hospital Research Institute, Ottawa, ON, Canada

    Larissa Shamseer & David Moher

  5. University of Ottawa, Ottawa, ON, Canada

    Larissa Shamseer

  6. St. Michael’s Hospital, Toronto, ON, Canada

    Clarence Chant

  7. Leslie Dan Faculty of Pharmacy, University of Toronto, Toronto, ON, Canada

    Clarence Chant & Brian Hardy

  8. School of Pharmacy, University of Waterloo, Waterloo, ON, Canada

    David J. Edwards

  9. Eastern Health, Memorial University of Newfoundland, St. Johns, NL, Canada

    Scott Edwards

  10. Faculty of Pharmaceutical Sciences, University of British Columbia, Vancouver, BC, Canada

    Mary H. H. Ensom

  11. Pharmacy Department, Children’s and Women’s Health Centre of British Columbia, Vancouver, BC, Canada

    Mary H. H. Ensom

  12. College of Pharmacy, Purdue University, West Lafayette, IN, USA

    David R. Foster

  13. Sunnybrook Health Sciences Center, Toronto, ON, Canada

    Brian Hardy & Scott Walker

  14. Department of Clinical Pharmacy, University of Colorado, Aurora, CO, USA

    Tyree H. Kiser

  15. Janssen-Cilag BV, Tilburg, The Netherlands

    Charles la Porte

  16. Burns Trauma and Critical Care Research Centre, The University of Queensland, Brisbane, QLD, Australia

    Jason A. Roberts

  17. Royal Brisbane and Women’s Hospital, Brisbane, QLD, Australia

    Jason A. Roberts

  18. Institute of Translational Medicine, The University of Liverpool, Liverpool, UK

    Jason A. Roberts

  19. University College London Hospitals NHS Trust, London, UK

    Rob Shulman

  20. College of Pharmacy, University of Manitoba, Winnipeg, MB, Canada

    Sheryl Zelenitsky

  21. Faculty of Medicine, University of Ottawa, Ottawa, ON, Canada

    David Moher

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  1. Salmaan Kanji
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  2. Meghan Hayes
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  3. Adam Ling
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  4. Larissa Shamseer
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  7. Scott Edwards
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  8. Mary H. H. Ensom
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  9. David R. Foster
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  10. Brian Hardy
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  11. Tyree H. Kiser
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  12. Charles la Porte
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  13. Jason A. Roberts
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  14. Rob Shulman
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  15. Scott Walker
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  16. Sheryl Zelenitsky
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  17. David Moher
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Corresponding author

Correspondence to Salmaan Kanji.

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Kanji, S., Hayes, M., Ling, A. et al. Reporting Guidelines for Clinical Pharmacokinetic Studies: The ClinPK Statement. Clin Pharmacokinet 54, 783–795 (2015). https://doi.org/10.1007/s40262-015-0236-8

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  • DOI: https://doi.org/10.1007/s40262-015-0236-8

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