RSO VITAL STATISTICS AND SIXTH ANNUAL REPORT. In 2003, the RSO assisted investigators in reviewing or preparing 73 clinical trial proposals. This number of formal reviews is decreased from the 115 proposals reviewed in 2002. However, the number of studies declined or ultimately withdrawn by the sponsor was only 23, compared with 65 the previous year. Thus, a greater fraction of RSO staff time was devoted to evaluating and preparing projects that were actually initiated. In other words, effectiveness increased last year.

These clinical trials are in various stages of development at the AHC. At the end of 2003, there were 100 active trials involving the RSO in some capacity, compared with 88 at the end of 2002. The number of projects for which the RSO was providing full services was 35. The number of projects in the pipeline at years' end was 42. Of these, 26 projects are in the final initiation stages and have an estimated contract value of $3.7 million. During 2003, RSO services for 34 projects were completed. To handle this volume of work, the RSO staff assigned to this function included 3.4 FTE research process managers, 3.3 FTE nurse research coordinators, 0.5 FTE administrative assistant, and one secretary.

These active research projects have an estimated contract value of > $10.9 million. An additional 26 projects in the final initiation stages (waiting final approvals or budget negotiation; final budgets are not yet available for several of these projects) have an estimated contract value of $3.7 million.

Twenty-three clinical trials were reviewed, but not undertaken. In four cases (17%), an adequate budget could not be negotiated. There was too little time to undertake the study in one case. Trials were not undertaken because of insufficient PI interest in the project in 5 cases (22%), and in 10 cases (43%) the sponsor withdrew the protocol (various or unknown reasons).

Researchers continue to commend RSO staff on the quality of their work. In 2003, the RSO worked with more than 59 different faculty members on their research projects. These faculty belong to 13 different departments in the Medical School, and to the College of Pharmacy, and School of Dentistry. The disciplines represented include rheumatology, endocrinology, pulmonary, hematology/oncology, gastroenterology, infectious diseases, cardiology, pediatrics, neurology, neurosurgery, urologic surgery, anesthesiology, psychiatry, dermatology, surgery, obstetrics/gynecology, therapeutic radiology, otolaryngology, and laboratory medicine and pathology.

The RSO began to provide some services at no expense to investigators in order to enhance the faculty's efficiency and effectiveness in competing for NIH funds for clinical research. These key pre-award services include protocol review and assistance with protocol development, budget development, preparation of IRB and other regulatory documents, and management of the approval process.

The RSO initiated a training program for research coordinators consisting of several modules, each with a different focus. Thus far more than 50 research coordinators have participated in and more than 30 research staffers are pre-registered for the March 2004 course.

The RSO staff completed development and implementation of standard operating procedures (SOPs) for all of the major activities in which the RSO is involved, both initiation and performance of clinical trials. These SOPs have been shared with at least three medical school departments.

The IND/IDE Assistance Program helped investigators with IND (Investigational New Drug application) or IDE (Investigational Device Exemption application) submissions and ongoing FDA communications when the investigators also serve as the sponsor of an IND or IDE. This program is unique among research universities. In 2003, more than 40 requests for assistance were received. There were 32 determinations regarding the necessity of filing an IND or IDE for a specific project, often in consultation with FDA officials. Five IND applications were submitted and 17 are in the process of being prepared.