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Journal of General Internal Medicine

, Volume 33, Issue 6, pp 792–794 | Cite as

Application and Impact of Run-In Studies for the Evaluation of Statin Efficacy and Safety

  • Michael Fralick
  • Jerry Avorn
  • Jessica M. Franklin
  • Emily Bartsch
  • Abdurrahman Abdurrob
  • Aaron S. Kesselheim
Concise Research Reports

KEY WORDS

run-in statin clinical trial study design 

Notes

Authors’ Contributions

Study concept and design: Fralick M, Kesselheim A, and Avorn J

Acquisition of data: Fralick M, Abdurrob A, and Bartsch E

Analysis/interpretation of data: Fralick M, Kesselheim A, Franklin J, Avorn J, and Bartsch E

Drafting of the manuscript: Fralick M

Critical revision of the manuscript: Kesselheim A, Franklin J, Avorn J, Abdurrob A, and Bartsch E

Statistical analysis: Fralick M and Franklin J

Funding

Dr. Fralick receives funding from the Eliot Phillipson Clinician-Scientist Training Program and the Clinician Investigator Program at the University of Toronto and from The Detweiler Travelling Fellowship funded by the Royal College of Physicians and Surgeons of Canada. This study is also funded by The Laura and John Arnold Foundation. Dr. Kesselheim’s work is also supported by the Harvard Program in Therapeutic Science and the Engelberg Foundation.

Compliance with Ethical Standards

Conflict of Interest

Dr. Franklin is the principal investigator on a grant from Merck. All remaining authors declare that they do not have a conflict of interest.

References

  1. 1.
    Pablos-Méndez A, Barr RG, Shea S. Run-in periods in randomized trials: implications for the application of results in clinical practice. JAMA. 1998;279(3):222–225.CrossRefPubMedGoogle Scholar
  2. 2.
    Rothwell PM. Factors that can affect the external validity of randomised controlled trials. PLoS Clin Trials. 2006;1(1):e9.CrossRefPubMedPubMedCentralGoogle Scholar
  3. 3.
    Fralick M, Avorn J, Franklin JM, Abdurrahman A, Kesselheim AS. Application and impact of run-in studies. JGIM. 2018.Google Scholar
  4. 4.
    Chou R, Dana T, Blazina I, Daeges M, Jeanne TL. Statins for prevention of cardiovascular disease in adults. JAMA. 2016;316(19):2008–2024.CrossRefPubMedGoogle Scholar
  5. 5.
    Dersimonian R, Laird N. Meta-analysis in clinical trials. Stat Med. 1986;188:177–188.Google Scholar

Copyright information

© Society of General Internal Medicine 2018

Authors and Affiliations

  • Michael Fralick
    • 1
    • 2
    • 3
  • Jerry Avorn
    • 1
    • 3
  • Jessica M. Franklin
    • 1
    • 3
  • Emily Bartsch
    • 3
  • Abdurrahman Abdurrob
    • 3
  • Aaron S. Kesselheim
    • 1
    • 3
  1. 1.Program on Regulation, Therapeutics, and Law (PORTAL), Division of Pharmacoepidemiology and Pharmacoeconomics, Department of MedicineBrigham and Women’s Hospital and Harvard Medical SchoolBostonUSA
  2. 2.Eliot Phillipson Clinician-Scientist Training ProgramTorontoCanada
  3. 3.Division of Pharmacoepidemiology and Pharmacoeconomics, Department of MedicineBrigham and Women’s Hospital and Harvard Medical SchoolBostonUSA

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