The recently announced international Children's Vaccine Initiative and the persisting demand for a safer pertussis vaccine have substantially increased the Division's responsibility for supporting development and testing of vaccines. In turn this requires better, more efficient methods to initiate and implement clinical trials through the Division's network of Vaccine and Treatment Evaluation Units (VTEUs), particularly multicenter rials. The Division has therefore established a Clinical Trials Support Effort to assist with all phases of clinical trials. Three contracts are being awarded in order to accomplish this goal. This contract will support data management, coordination, and analysis, while a second contract (RFP #91-36) will be for a facility to make and distribute test vaccines and drugs and serve as a repository for clinical specimens, and a third contract (RFP #91-37) will support clinical monitoring and the preparation and distribution of protocol and regulatory information. In particular, the purpose of this contract is to provide a Data Coordinating Center for managing several of DMID's multicenter clinical and/or epidemiologic studies, including a five year clinical trial of new pertussis vaccines in approximately 60,000 infants and approximately three other trials of vaccines or treatments for infectious diseases, each involving a few hundred subjects and of approximately two years duration. Working with NIAID supported clinical investigators and the NIAID Project Officers, the Contractor will participate in a key way as a coordinating center during the various phases of each study. The Contractor's major responsibilities will be to (1) support the Division and its investigators with appropriate research design, (2) develop and implement data management procedures and customized software programs, and use these to enter, correct, assemble and store study data, (3) monitor the conduct of studies to ensure data accuracy, integrity and uniformity, (4) provide interim statistical analyses and timely reports as specified during the trials, (5) assist in the final data analysis, and (6) assist in writing manuscripts or other reports on study results.
