If animal tests go well, the next
trials will be with
humans, a process that involves three stages — one for safety, the next to see if the protein kills cancer in a limited
number of people, and the last to turn it loose in a large group.
In a substudy, review outcomes were also compared across different types
of clinical research, based in large part on the designations and definitions derived from a
number of sources, including a report by Nathan, 14 the Institute
of Medicine, 20 the NIH Director's Panel on Clinical Research, 9 the Association
of American Medical Colleges and American Medical Association, 21 and the Agency for Healthcare Research and Quality.22 All 3599 R01 applications involving
human subjects that were submitted to NIH for the October 2002 council were categorized into 1
of the following: (1) patient - oriented studies
of mechanisms
of human disease (bench to bedside); (2) clinical
trials and other clinical interventions; (3) patient - oriented research focusing on development
of new technologies; (4) epidemiological studies; (5) behavioral studies (including studies
of normal
human behavior); (6) health services research; and (7) use
of deidentified
human tissue.
While there have been a
number of human clinical studies, we need larger, randomized, properly - controlled clinical
trials that look specifically at these suspects.