VA Cooperative Studies Program (CSP)

CSP Coordinating Center - Palo Alto, CA

Palo Alto CSP Coordinating Center is located at the Mountain View Division of the VA Palo Alto Healthcare System. The center was established in September 1978 under the direction of Dr. Kenneth James. In 1992, Dr. Philip Lavori became the Director and oversaw many accomplishments including the upgrading and streamlining of the center's data collection system. The center's academic relationship was also strengthened with Stanford University, enabling greater collaboration with both VA and Stanford investigators. Dr. Lavori's renown in clinical trials added to the prominence of CSP as a whole when he was appointed Acting CSP Director from 2002-2004. Dr. Javaid Sheikh was Center Director from 2005-2006, and led the center through its successful application for funding renewal in 2006. In 2007 Dr. Mark Holodniy became the Acting Director. Dr. Holodniy is Professor of Medicine (Infectious Diseases & Geographic Medicine division) at Stanford University. He directed the HIV clinical program and AIDS Research Center at VA Palo Alto Health Care System since 1991. Dr. Holodniy is also a staff member in the VHA Office of Public Health and Environmental Hazards, and directs the Office of Public Health Surveillance & Research. He led Palo Alto's efforts on CSP-wide projects to increase standardization across CSP Centers. In September 2009, Dr. Ying Lu was recruited from the University of California San Francisco to take the permanent center Director position. Dr. Lu was also accepted as Professor of Biostatistics in the Department of Health Research and Policy at Stanford University. In March 2021, Dr. Ying Qing Chen became the Center Director. He is Professor of Medicine from the Stanford Prevention Research Center at Stanford University.

The center's record and experience in clinical trials has changed or has the potential to change the practice of medicine in VA and nationally across several disciplines. Since its inception, the center has conducted over 30 cooperative studies. Notable studies coordinated by the Palo Alto CSPCC include:

• Stroke prevention in non-valvular atrial fibrillation
• Strategies for reducing non-Q-wave mortality and morbidity
• Enhancing the quality of informed consent for clinical trials
• Cognitive behavioral treatment for post-traumatic stress disorder in women
• A thyroid hormone analog to treat heart failure (the first CSP Phase II trial)

Facilities, Staff, and Equipment

Palo Alto CSPCC has a staff of more than forty people consisting of biostatisticians, statistical programmers, project managers, project coordinators, data managers, research assistants/coordinators, information technologists, clinical data associates, a quality assurance specialist and administrative support personnel. For each cooperative study, a biostatistician and a project manager head a study team consisting of one or more statistical programmers, data managers, and research assistants.

Palo Alto Information Technology (IT) group provides full support to the statistical Coordinating Center, as well as support to several other local research centers including the Health Economics Resource Center, the Program Evaluation and Research Center and the Center for Health Care Evaluation. This combined support allows for maximum utilization of IT staff and computing systems. IT group maintains a secure, environmentally-controlled computing facility for the centers and other local research groups.

Data collection capabilities at the Palo Alto CSPCC have been developed to efficiently manage multiple studies. In 2009 the center began using the CSP Electronic Data Capture and Clinical Trial Management System, which involves Microsoft SharePoint and InfoPath software and will be the CSP-wide standardized method for data collection.

The Palo Alto CSPCC is also unique in its operation and management of the CSP DNA Bank Coordinating Center (DNACC). The DNA Bank is a program-wide genetic tissue databank for CSP and was developed to provide a consistent method to collect and store DNA from CSP studies. DNACC staff are responsible for the administrative and regulatory aspects of the genetic tissue banking trials, such as working with investigators to develop banking proposals, working with participating sites to answer local IRB issues, and assisting in the coordination of the oversight committees that deal with the ethical, legal, and social issues of banking and using genetic tissue. DNACC maintains the database with the clinical study data, the DNA assay results and the "crosswalk" that links the patient study ID to the bank specimen code. The Genetic Tissue Core Laboratory, housed at the Massachusetts VA Epidemiological Research and Information Center (MAVERIC) in Boston, serves as the central repository for specimens.

Academic Affiliations

• Stanford University School of Medicine
• Stanford University Department of Health Research and Policy

Updated April 2021

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