Abstract

There has been a recent trend in medical research towards a more collaborative relationship between statisticians and clinical investigators. This has led to an increased focus on the most efficient and effective ways to structure, conduct, and measure the impact of organizations that provide statistical services to clinical investigators. Several recent guidelines and recommendations on the conduct of statistical consulting services(SCSs) have been made in response to this need, focusing on larger SCSs consisting primarily of faculty and staff statisticians. However, the application of these recommendations to consulting services primarily staffed by graduate students, which have the dual role of providing a professional service and training, remains unclear. Guidelines and recommendations, primarily from the Clinical and Translational Science (CTSA) consortium, were applied to a SCS staffed primarily by graduate students in an academic health center. A description of the organizational structure and outcomes after 3 years of operation is presented. The guidelines recommended by the CTSA consortium and other groups were successfully incorporated into the graduate consulting laboratory. At almost one new project request per week, the consulting laboratory demonstrated a large bandwidth and had an excellent feedback from investigators. Guidelines developed for larger statistical consulting organizations are able to be applied in student-led consultation organizations. Outcomes and recommendations from 3.5 years of operation are used to describe the successes and challenges we have encountered.

Highlights

  • There has been a recent trend in medical research towards a more collaborative relationship between statisticians and clinical investigators

  • Recommendations describing the operational structure, metrics, and the evaluation of statistical consulting services (SCSs) have been provided [4,5,6,7,8]. These guidelines are intended for relatively large SCSs, including academic departments, Biostatistical, Epidemiology, and Research Design (BERD) cores of Clinical and Translational Science Awards (CTSA), and SCSs within National Cancer Institute-designated Cancer Centers (NCICC), all of which focus primarily on furthering the research profile of the Institutes of higher learning (IHL) or academic health centers (AHCs)

  • The primary consultant performs the analysis described in the statistical analysis plan (SAP), with all work reviewed by the secondary consultant and Biostatistical Consulting Laboratory (BCL) Supervisor

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Summary

Introduction

There has been a recent trend in medical research towards a more collaborative relationship between statisticians and clinical investigators. Recommendations describing the operational structure, metrics, and the evaluation of SCS have been provided [4,5,6,7,8] These guidelines are intended for relatively large SCSs, including academic departments, Biostatistical, Epidemiology, and Research Design (BERD) cores of Clinical and Translational Science Awards (CTSA), and SCSs within National Cancer Institute-designated Cancer Centers (NCICC), all of which focus primarily on furthering the research profile of the IHL or AHC. This included the original draft as well as responding to BCL Associate and Supervisor comments

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