The primary mission of the Clinical Services Program (CSP) is to perform sequential
studies of immune function in patients with cancer, HIV/AIDS, and other diseases
where the immune response plays a central role in disease development or where the
disease results from genetic defects that alter the immune response. In cancer and
HIV/AIDS, the clinical trials supported by the program involve treatment of patients
with immune modulators including vaccines. These clinical trials are designed with
primary or secondary endpoints being to identify changes in immunologic parameters
that may be involved in clinical responses. Results are used to design second-generation
clinical studies and guide basic research into the agent's mechanism(s) of
action. Studies of HIV/AIDS also require the capacity to sequentially monitor the
viral burden of patients during therapy to quickly identify development of resistance.
The commitment to a strong virology program also permits an opportunity to study
genetic alterations in the virus that confer drug resistance. It is recognized that
downstream applications for clinical samples are not possible without appropriate
sample preparation that involves the reproducible preparation of samples for testing
or cryopreservation. It is also a mission of the program to participate in natural
history and long term epidemiologic studies of cancer in normal or at risk populations.
The program participates in both internal and external proficiency testing programs
and individual laboratories are certified for high complexity testing under the
Clinical Laboratory Improvement Amendment of 1988 (CLIA).