Selection of Appropriate Endpoints
May 22-23, 1997, Bethesda, MD Wasting and cachexia are two variants of a similar derangement in metabolism that ravages those individuals affected. Seen most often in patients with HIV infection, cancer, chronic renal and gastrointestinal diseases and in the elderly, wasting and cachexia are significant factors in the morbidity and mortality associated with these conditions. Many new treatments are now available, however both the pharmaceutical and regulatory communities have been limited by their inability to accurately assess their efficacy due to the lack of sensitive and specific endpoints.
Using the workshop model employed previously to address key issues in health care, the LSRO along with a consortium of supporters from the intramural and extramural NIH communities, the clinical/academic community, the pharmaceutical community and the FDA, convened a workshop to address our current knowledge about wasting and cachexia and their impact on five clinical groups, patients with HIV infection, cancer, chronic renal and gastrointestinal disease, and the elderly. Special consideration was also given to the evaluation of new treatments in children with these conditions.
The LSRO has produced a proceedings of this workshop which includes presentations of extant knowledge, gaps in that knowledge, and the reports of working groups designated to address specific questions and develop agendas for resolution. In addition to bridging gaps between key stakeholder groups and advancing the scientific agenda, this workshop resulting in the formation of a permanent working group that has already issued guidelines for clinical trials that will have an immediate impact on the speed and effectiveness with which new treatments will be evaluated. It is particularly gratifying to note that as a consequence of this effort, LSRO was a co-recipient of the 1998 Department of Health and Human Services, Distinguished Service Award.
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