Core--Administration, Biostatistics, Data Management

Baylor Research Institute, Dallas TX

Investigators

Linked publications & trials

Abstract

This program will interface clinical and tissue culture studies that will exploit dendritic cells in the[unreadable] induction of strong immunity to melanoma. An administrative core will carry out functions that interface with[unreadable] the 3 subprojects and with the cores for cell production and for immunologic monitoring. The administrative[unreadable] core will include administrative assistants in Dallas and New York who will function to: (1) Ship patient[unreadable] samples and sera that are to be assayed in the cores and in the interactive experimental aims; (2) To[unreadable] arrange joint meetings between the investigators and external advisors in New York and Dallas; (3) Prepare[unreadable] protocol submissions and annual renewals to the institutional review boards; (4) Arrange contacts and[unreadable] prepare reports to the NCI; (5) Procure and maintain informed consents for therapies, blood, and tissue[unreadable] sampling; (6) Help to prepare, submit, and track manuscripts; (7) Enter and maintain a shared reference data[unreadable] base; (8) Monitor budgets; (9) Manage personnel including immigration, stipends, benefits and housing; (10)[unreadable] Coordinate equipment maintenance and repair. The administrative core will support centralized biostatistics[unreadable] and data management personnel in New York, and Dallas. A Contract has been signed between Baylor[unreadable] Research Institute and biostatistical firm, Statistics Collaborative, to address all the biostatistics matter[unreadable] needed at BUR. The president of the company, Janet Wittes, PhD, is a respected Biostatistician who will[unreadable] serve as a collaborator to the Program Project. This group has had a major input in the design of the trials[unreadable] proposed in this revised application. A five person external advisory committee has agreed to serve the[unreadable] program and includes outstanding investigators in the fields of dendritic cells, immunotherapy of human[unreadable] melanoma, biology of Regulatory T cells, and immunotherapy of human myeloma.