Stem Cell and Gene Therapy Clinical Trial Program
Stem Cell and Gene Therapy Clinical Trial Program (SCGT-CTP)
The SCGT-CTP is made up of 17 staff and has a main objective of supporting and executing cell and gene therapy clinical trials at Stanford, either industry-sponsored or Stanford investigator-sponsored. Many of the gene therapy clinical trials at Stanford hospitals that are sponsored by industry entities have been managed and run through the CTP. The SCGT CTP covers 4 main areas of research that range from pre-clinical development to fulfilling all sponsor related roles for enrolling clinical trials. The Regulatory portion aids in clinical protocol and eCRF development, is responsible for all FDA interactions and filings from the pre-IND phase through IND close out and works with all internal regulatory bodies. The regulatory team has Stanford internal, industry and FDA regulatory experience. Because of the range of expertise and experience, the team is also involved in the development of School of Medicine and LPCH wide related policy and protocol development, which not only benefits the CDCM, but the University as a whole. The second main area is the Budget and Research Financials portion, which covers budget development, pre and post contracting budget management, internal and external vendor management, invoicing and patient account reconciliation. In addition, this team aids in the preclinical development.
The team develops budget predictions performs pre-clinical to completed clinical trial project management and aids in all aspects of study implementation. The third area of expertise is Quality Assurance and Safety. This area performs all monitoring for our investigator initiated trials, regulatory document management, quality auditing, SOP and guideline development, DSMC Coordination and Safety and Pharmacovillegence Surveillance. The final area is the Clinical Operations portion of the SCGT CTP, which is responsible for the execution of the clinical trial at the patient level. Clinical operations is responsible for all informed consent preparations, data collection and entry, adverse even surveillance and reporting, patient logistics coordination, manufacturing coordination, investigational product management and Good Clinical Practice and protocol adherence.
The SCGT-CTP has also attracted further partnership conversations with biotech companies which see an advantage in a savvy academic medical center with its own dedicated staff for cell and gene therapy. The FDA regulatory knowledge and clinical trial expertise has created substantial valuable institutional knowledge that cannot easily be replicated and allows for Stanford’s investigators to receive crucial guidance in trial design data points and considerations. The CTP staff has a wide range of expertise with both academic and industry experience, as well as basic and clinical research backgrounds, which allows the team to assist investigators in all aspects of their bench to bedside projects. Currently, the SCGT CTP is running 11 phase I or II clinical trials, 3 of which are Stanford investigator-initiated trials. There are a total of 19 active clinical trials managed by the CTP ranging from standard industry sponsored trials of experimental drug treatments to novel cellular and gene therapies. There are currently seven investigator-initiated INDs in development. The SCGT-CTP has established itself as the gold standard in development and execution of clinical trials at Stanford University. Because of the expertise and reputation that has been built, many members of the team serve on School of Medicine and LPCH boards and working groups that are improving the way research is performed at the hospitals and University.