Document 1089
 DOCN  M94A1089
 TI    New methodologies for clinical trials.
 DT    9412
 AU    Cheng B; Project Inform, San Francisco, CA 94103.
 SO    Int Conf AIDS. 1994 Aug 7-12;10(2):211 (abstract no. PB0858). Unique
       Identifier : AIDSLINE ICA10/94371486
 AB    Twelve years into the AIDS pandemic and we continue to have minimal
       knowledge on how to best use currently approved antiretroviral
       therapies. Clinical studies of these therapies have commonly produced
       confusion rather than clarification on use of these drugs. New
       methodologies for clinical trial designs are needed. Although surrogate
       markers have proven to be unrellable predictors of survival, they remain
       good predictors for disease progression. Clinical endpoint studies are
       problematic because the endpoints differ in severity (survival outcome
       for pneumocystis carinii pneumonia (PCP) is different than that for
       progressive multifocal leukoencephalopathy (PML)). Additionally, most
       clinical endpoint studies only count the first opportunistic infection
       and ignore all subsequent infections. A scaling system based on the
       severity of the infection is needed and should be updated annually, or
       as new preventative and treatment therapeutics become available. If this
       scaling system were incorporated with baseline antiviral resistance
       data, baseline viral phenotype, knowledge of potential drug
       interactions, immunological markers, and the recording of all cases of
       all opportunistic infections during an antiretroviral drug study, then
       such a study would provide us with more meaningful and useful data for
       the best use of these drugs.
 DE    Acquired Immunodeficiency Syndrome/*THERAPY  Clinical Trials/*METHODS
       Human  Research Design  MEETING ABSTRACT

       SOURCE: National Library of Medicine.  NOTICE: This material may be
       protected by Copyright Law (Title 17, U.S.Code).