Spectrum builds upon the 46-year history of the Stanford GCRC, and efforts to support clinical and translational research through the ACCESS office which was established in 1998, and later became SPCTRM in 2005.
In 2006, the SoM conducted a detailed survey of the faculty to identify major challenges both to our mission and to meeting the intent of the CTSA. We also initiated an intense series of discussions and committee meetings, involving a diverse cross-section of Stanford and the surrounding community, to identify areas in need of improvement or that required full-scale transformation. This culminated in the formation of the Stanford Center for Clinical and Translation Education and Research (SCCTER), a new Independent Academic Center to accelerate the application of scientific discoveries to patient care and improvements in human health. SCCTER is now known as Spectrum.
History of SPCTRM (Stanford/Packard Clinical and Translational Research in Medicine)
In 1997 a Dean's task force on clinical research recommended establishing a centralized office for clinical research at Stanford University, unanimously approved by the clinical department chairs. Funded by the Office of the Dean of the School of Medicine, ACCESS opened in 1998 to facilitate clinical research and collaborations between academia and industry that result in advancement of knowledge and improvement in health. ACCESS - Academic Consortium for Clinical Excellence in Scientific Studies.
Timeline of SPCTRM Initiatives (formerly ACCESS Clinical Trials Office)
2005
- First Annual SPCTRM Holiday Open House- 7 December (over 100 attended).
- SPCTRM, in association with the Department of Health Research and Policy, offers Pre-award Statistical Consultations
- SPCTRM Launch - 1 November.
- Nick Gaich named as the new SPCTRM Chief Operating Officer.
- ACCESS Clinical Trials Office is now known as "SPCTRM," Stanford/Packard Center for Translational Research in Medicine, 1 September
2004
- Fifth Annual ACCESS Educational symposium, "Innovations in Clinical Research," featuring keynote speaker Philip Pizzo, MD, Dean of the School of Medicine, Stanford University - 4 October (over 200 attended).
- ACCESS launched (initially as a pilot) an internship program with UCSC, so that trained/skilled UCSC students in the Clinical Trials Design and Management Certificate Program have the opportunity to gain some Stanford work experience that could lead to potential employment, benefiting both the students and the preceptor here at Stanford.
2003
- A separate Working Group of representatives from key faculty departments (referenced in the Dean's newsletter, 11/15/04) met throughout 2003 to assist the Dean in this process. The name: Stanford/Packard Center for Translational Research in Medicine (SPCTRM) was suggested by a member of this group, Branimir Sikic, MD.
- Offers two CME/CE approved educational series: "Fundamentals of Clinical Trials, Start to Finish" and "Understanding and Applying Principles of Good Clinical Practice (GCP)."
- Fourth annual ACCESS symposium, "Compliance and Integrity in Clinical Research at Stanford," The Rules of the Road for 2003, featuring keynote speaker Arthur Rubenstein, MBBCh, Vice President and Dean, University of Pennsylvania School of Medicine, 20 October (219 attend).
- Helps to organize and implement a School-wide Health Screening Safety and Compliance (HSSC) program for University clinical research staff involved with human subjects.
2002
- Begins hosting ACRP (Association of Clinical Research Professionals) CCRC and CCRA Examinations and Preparation Classes at Stanford University
- Third annual clinical trials symposium: Safety and Accountability in Clinical Research at Stanford, featuring keynote speaker Greg Koski, MD, PhD, Director, Office for Human Research Protections, Department of Health and Human Services, 7-October (over 350 attend)
2001
- ACCESS institutes CME/CE-approved workshops to provide continuing education and professional development for clinical research staff
- Introduces CME/CE-approved Research Coordinator Roundtable networking events "Trials and Tribulations"
- Steven Alexander, MD, Professor of Pediatrics/Nephrology named ACCESS Medical Director
- Second ACCESS symposium for clinical research personnel: Conducting Clinical Trials: The Stanford Experience , 17- September (over 250 attend)
2000
- ACCESS Clinical Trials Center (H-104) opens
- Initiates orientation to clinical research for new staff members
- Roll out of ACCESS study-related services to investigators and coordinators
- ACCESS web page redesigned to offer information for faculty investigators, research coordinators, patients and sponsors
1999
- First ACCESS clinical trials symposium at Stanford: Conducting Clinical Trials: The Stanford Experience, 13 July (over 150 attend)
- Creation of Clinical Research Staff Database to network clinical researchers at Stanford
1998
- ACCESS Clinical Trials office opens
- Charles Prober, MD, Professor Pediatrics/Infectious Diseases and of Microbiology and Immunology named ACCESS Medical Director
- University approves lowering the clinical research indirect cost rate from 31% to 25%
- Focused efforts to establish Clinical Trial Master contract agreements with as many sponsors as possible to streamline contract negotiation time
- Negotiates research discounts on multiple Hospital-based tests and procedures
- Development and implementation of software application for the Research Management Group (RMG) to produce accurate clinical trial budgets, including up-front fixed expenses, realistic effort reporting, per patient expenses, and line-item contingency
1997
- Clinical chairs unanimously approve Clinical Research Task Force recommendation to establish a centralized office for clinical research
1996
- University policy change that acknowledges industry ownership of intellectual property contained in clinical research protocols
1995
- Publication of faculty ad hoc committee's "Barriers Report" underscores potential impediments to industry-academic relationships in the conduct of clinical research
- Appointment of Clinical Research Task Force by Dean Bauer to evaluate methods to facilitate conduct of industry-sponsored clinical research