To: Duke Medicine Faculty and Staff
From: Victor J. Dzau, MD, Chancellor for Health Affairs and CEO, Duke University Health System; Sally Kornbluth, PhD, Vice Dean for Research, Duke University School of Medicine; Robert M. Califf, MD, MACC, Vice Chancellor for Clinical Research; Director, Duke Translational Medicine Institute
Subject: Translational Medicine Quality Framework Document -- Review Requested
Attached you will find an an important document, as well as an accompanying slide set, that we hope you will take a moment to read and, more importantly, provide us with any comments or suggestions you might have. 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, we convened a multidisciplinary group of faculty to develop a quality framework related to this kind of work. Chancellor Dzau charged this group to move rapidly but with due deliberation.
Over the past six months, this Translational Medicine Quality Framework (TMQF) Committee produced a 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. The TMQF Committee and External Review Panel members are listed in the document. This report has also been shared with the Basic Science and Clinical Department Chairs and Center/Institute Directors. An implementation plan will follow.
We recognize the outstanding quality of your work and seek through this effort to establish an improved institutional approach to supporting it. The proposed framework comprises four key elements:
- Improved bioinformatics support for our laboratories;
- Improved access to biostatistical collaboration and support;
- An enhanced system of accountability within the operational research units; and
- A formal assessment of studies before they move into human trials, one that will involve a degree of rigor far exceeding current standards.