Dear Duke Medicine Faculty and Staff:

Attached you will find an important document, as well as an accompanying slide set, that we hope you will read carefully. As you are likely aware, Duke has been the focus of scrutiny recently because of issues surrounding several clinical trials, now stopped, in which genomic predictors were used to guide study treatment. In order to understand these issues, learn from this experience, and apply these learnings to the creation of a more comprehensive approach to ensuring the quality and integrity of research in this area, Chancellor Dzau convened a multidisciplinary group of faculty to develop a quality framework related to this kind of work.

In March 2011, this Translational Medicine Quality Framework (TMQF) Committee produced a draft report outlining the proposed principles for this framework. We also convened a distinguished group of outside advisors who reviewed the document and provided their perspectives and guidance. Following an open comment period, the principles were finalized on May 1, 2011. An implementation plan is currently in development.

We recognize the outstanding quality of your work and seek through this effort to establish an improved institutional approach to supporting it. The framework includes four key elements:  

1. improved bioinformatics support for our laboratories;
2. improved access to biostatistical collaboration and support;
3. an enhanced system of accountability within the operational research units; and
4. a formal assessment of studies before they move into human trials, one that will involve a degree of rigor far exceeding current standards.

 We have shared our report with the Institute of Medicine as they have initiated deliberations on this topic as well. We urge you to read it carefully and to engage with your leaders and colleagues in a serious discussion of its implications.

You may access the document and accompanying slides below. Please send any comments to tmqffeedback@duke.edu. We welcome your thoughts and suggestions as we strive to create a better system for supporting your research.

Thank you,

Victor J. Dzau, MD
Chancellor for Health Affairs and CEO, Duke University Health System

Robert M. Califf, MD, MACC
Vice Chancellor for Clinical Research and Director, Duke Translational Medicine Institute

Sally Kornbluth, PhD
Vice Dean for Research, Duke University School of Medicine

Principles from the Duke Medicine Translational Medicine Quality Framework Committee

Slides

Research Laboratory Assessment Tool