Memorandum of Understanding Between
The United States Food and Drug Administration
Office of Critical Path Programs
This Memorandum of Understanding (MOU) between the U.S. Food and Drug Administration (FDA) and Duke University (Duke) formalizes an agreement to develop collaborative activities in the areas of research, education, and outreach.
The purpose of this MOU is to establish terms of collaboration between FDA and Duke, beginning with an initiative to reexamine the clinical trials process. To this end, Duke will be the convener of a Public Private Partnership (PPP), to which FDA will be a founding partner, to systematically modernize the clinical trial process. This initiative will add a unique aspect to the training being provided to the next generation of health care professionals at Duke, and provide FDA with a mechanism to promote one aspect of their Critical Path agenda, the modernization of clinical trials. Participants will have the opportunity to participate in a program that will focus on clinical trial quality. FDA and Duke will explore the possibilities of other collaborative activities including: sabbaticals, pre-doctoral and post-doctoral fellowships and student internships as this partnership develops.
FDA and Duke have a shared interest in strengthening human subject protection by modernizing the conduct of clinical trials to ensure that design, execution, and analysis are of optimal quality. Duke’s mission includes a commitment to help those who suffer, cure disease and promote health through sophisticated medical research and thoughtful patient care. This mission is consistent with a fundamental part of FDA’s mission to protect and promote public health. Both FDA and Duke endorse scientific training for government employees, academicians, and students to establish a solid foundation in interdisciplinary science and medicine.
III. Substance of MOU
For this initiative, participants may include Duke students, residents, fellows, and faculty or FDA staff.
Through the PPP described above, this national effort will focus on developing generalizable standards to ensure that clinical trials are as efficient as possible, without compromising the reliability of the inferences drawn. The primary focus will be on clinical trial conduct in the United States, but global implications will be considered.
The parties agree to the following in support of this effort:
• The creation of PPP, consisting of the following components:
• Executive Committee to be composed of members from involved parties;
• Steering Committee to provide direction and guidance in support of this effort; and
• Core functional groups to implement strategies to achieve the outlined deliverables.
• To collaborate in order to achieve short-term deliverables, such as:
• Standards for monitoring and auditing;
• Standards for data quality and quantity;
• Standards for case report forms; and
• Identification of pragmatic research topics (research on research).
• To collaborate in order to achieve long-term deliverables that reeaximine the clinical trial enterprise, such as:
• Developing a functional definition of clinical trial types with descriptions of optimal quality parameters;
• Developing a model for the "ideal" clinical research site;
• Developing metrics for evaluating site functionality;
• Developing metrics for evaluating site quality (cleanliness of data, inclusiveness of enrollement, HSP, etc.);
• Developing best practices for key processes (Clinical Trial Management Systems);
• Developing best practices for interface of the site with key components of research enterprise;
• Exploring the concept of a clinical trial site accreditation program (including training);
• Exploring the concept of Individual investigator and support personnel credentialing program; and
• Assess customer (i.e., public, industry, and regulators) satisfaction.
FDA Office of Critical Path Programs (OCPP) will provide the following:
• Scientific and regulatory expertise related to the objectives of the partnership;
• Project management to achieve the short-term and long-term deliverables;
• Opportunities to participate in certain training courses and seminars at FDA or web-based training provided through FDA or Center Staff College’s, as resources permit;
• Communication with OCPP staff via face-to-face meetings, conference calls or teleconference; and
• Communication of this collaborative effort through web pages, press releases, informal conversations with colleagues, faculty and students, joint conferences and symposia.
Duke will provide the following:
• Function as a host of the PPP;
• Proactive efforts in establishing collaborative research efforts;
• Continuing and frequent communication with Duke faculty and staff, to include face-to-face communication and teleconferences;
• Welcome to FDA staff wishing to visit relevant Duke programs and laboratories;
• Communication of this collaborative effort through web pages, press releases, informal conversations with colleagues, faculty and students, joint conferences and symposia;
• Encouragement of graduate students/residents to elect short-term opportunities at FDA; and
• Opportunities to attend graduate courses.
Duke and FDA may decide to enter into a Cooperative Research and Development Agreement (CRADA) at a future time to conduct collaborative research and projects of mutual interest. The terms of such a CRADA will address Intellectual Property rights.
Finances and Resources
Duke and FDA agree that this MOU does not commit either to make specific levels of financial or personnel support or to provide specific office or laboratory space for the programs and that the provision of such support will be based on available resources and provided in accordance with the laws,, regulations and policies under which each entity operates.
Citizenship and Security Clearance
Duke participants in the collaboration envisioned in this MOU will be United States citizens or permanent residents. Information may be obtained from participants by the Agency for security clearance or access to FDA facilities and offices. The information obtained may be re-disclosed to the other Federal agencies for in fulfillment of official responsibilities to the extent that such disclosure is permitted by law.
Protection of Non-Public Information
As a condition of their participation, Duke participants whose involvement will require access to any information that is not customarily releasable by FDA to the public will be required to sign an appropriate commitment to protect non-public information, to be provided by FDA.
IV. Liaison Contact
The individual to whom all inquiries to FDA should be addressed is:
Senior Regulatory Program Manager
Office of Critical Path Programs
Office of the Commissioner
Food and Drug Administration
The individual to whom all inquiries to Duke should be addressed is:
Deborah A. Roth
Associate Dean for Clinical Research Administration
Chief Operating Officer
Duke Translational Medicine Institute
Approved and Accepted
for Duke University
Signed by: R. Sanders Williams, M.D.
Dean, School of Medicine
Date: September 20, 2007
Approved and Accepted
for the Food and Drug Administration
Signed by: Janet Woodcock, M.D.
Deputy Commissioner and Chief Medical Officer
Date: September 22, 2007
and Duke University
Durham, North Carolina