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.
Additional Files
- 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.aac7019This 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.