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Impact of guidance documents on translational large animal studies of cartilage repair

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Science Translational Medicine  21 Oct 2015:
Vol. 7, Issue 310, pp. 310re9
DOI: 10.1126/scitranslmed.aac7019
  • Fig. 1. Recommendations from regulatory agencies for appropriate descriptors and outcomes for translational large animal studies in cartilage repair.

    Color scheme indicates whether the documents provide detailed (green), loose (yellow), or no (red) recommendations in a category.

  • Fig. 2. Literature search, screening, and eligibility testing using the Preferred Reporting Items for Systematic Reviews and Meta-analyses (PRISMA) guidelines (29).
  • Fig. 3. Array depiction and quantification of adherence to guidance document recommendations.

    Each row indicates a different category (top, descriptors; bottom, outcomes), whereas each column represents an individual study. Green indicates full adherence, red indicates nonadherence, and yellow indicates partial adherence. Bars at right show average percentage adherence across all studies in a given category.

  • Fig. 4. Study number and adherence as a function of year, species, study duration, and number of animals.

    (A) Number of studies per year (*through 18 April 2014). (B) Overall adherence by study and year. Vertical lines indicate the time of publication of the *ASTM, #FDA, and §EMA documents. Regression shows slight increase in overall adherence with time (P = 0.004, R2 = 0.07, slope = 0.63%/year). (C) Mean adherence per year, broken out into overall, study descriptors, and study outcomes. Study descriptors were reported at a higher level than study outcomes. Standard deviation is shown for overall adherence only. (D) Adherence (in percent) across species (white bars, study descriptors; hatched bars, study outcomes; black bars, overall adherence; *P < 0.05). (E and F) Correlation between overall adherence and study duration (R2 = 0.075, P = 0.003) (E) and overall adherence and the number of animals (R2 < 0.001, P = 0.994) (F).

Supplementary Materials

  • www.sciencetranslationalmedicine.org/cgi/content/full/7/310/310re9/DC1

    Supplementary analyses: Species-specific findings (methods, findings, and figures).

    Fig. S1. Species-specific animals and study numbers.

    Fig. S2. Species-specific study design and treatment parameters.

    Table S1. Recommendations by regulatory agencies 1.

    Table S2. Recommendations by regulatory agencies 2.

    List of publications assessed in the systematic review and analysis.

  • Supplementary Material for:

    Impact of guidance documents on translational large animal studies of cartilage repair

    Christian G. Pfeifer, Matthew B. Fisher, James L. Carey, Robert L. Mauck*

    *Corresponding author. E-mail: lemauck{at}mail.med.upenn.edu

    Published 21 October 2015, Sci. Transl. Med. 7, 310re9 (2015)
    DOI: 10.1126/scitranslmed.aac7019

    This PDF file includes:

    • Supplementary analyses: Species-specific findings (methods, findings, and figures).
    • Fig. S1. Species-specific animals and study numbers.
    • Fig. S2. Species-specific study design and treatment parameters.
    • Table S1. Recommendations by regulatory agencies 1.
    • Table S2. Recommendations by regulatory agencies 2.
    • List of publications assessed in the systematic review and analysis.

    [Download PDF]

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